Worldwide Report: Immunoassay Plus - Lot 40440 - Exp 28 Feb 2026

July 2024
Conventional Units
Worldwide Report
Immunoassay Plus • Lot 40440 • Exp 28−Feb−2026
17−Alpha−Hydroxyprogesterone Chemiluminescence ng/mL

Level Mon Cum Level Mon Cum Level Mon Cum
Snibe MAGLUMI
Mean 0.410 0.565 1.59 1.92 4.96 5.94
SD
CV
1 0.000
0.0
0.064
11.2
2 0.000
0.0
0.206
10.7
3 0.000
0.0
0.482
8.1
# Points 1 26 1 22 1 25
# Labs 1 1 1 1 1 1
Snibe MAGLUMI Series

Mean 0.558 0.564 2.13 2.15 6.35 6.39
SD
CV
1
0.061
11.0
0.062
11.0
2 0.196
9.2
0.189
8.8
3 0.469
7.4
0.449
7.0
# Points 316 1142 316 1151 312 1130
# Labs 8 10 8 10 8 9
Snibe MAGLUMI Series • Snibe MAGLUMI 17−OH Prog. REF 130X98004M

Mean 0.643 0.570 2.28 2.03 −− −−
SD
CV
1
0.027
4.2
0.060
10.5
0.153
6.7
0.216
10.7
2 3 −−
−−
−−
−−
# Points 7 27 7 26 −− −−
# Labs 1 1 1 1
YHLO iFlash
Mean 0.490 0.541 1.87 2.02 6.01 6.45
SD
CV
1 0.030
6.1
0.041
7.6
2 0.130
7.0
0.132
6.5
3 0.250
4.2
0.377
5.8
# Points 20 199 20 199 20 198
# Labs 1 1 1 1 1 1
YHLO iFlash 3000

Mean 0.460 0.439 1.95 1.90 5.53 5.82
SD
CV
1 0.030
6.5
0.036
8.2
2 0.100
5.1
0.334
17.6
3 0.170
3.1
2.72
46.8
# Points 28 123 28 123 28 123
# Labs 1 2 1 2 1 2
Method Group • Chemiluminescence

Mean 0.548 0.551 2.10 2.11 6.26 6.35
SD
CV
1
0.066
12.1
0.067
12.2
2 0.203
9.6
0.214
10.2
3 0.502
8.0
0.906
14.3
# Points 372 1517 372 1521 361 1476
# Labs 12 15 12 15 11 13
17−Alpha−Hydroxyprogesterone EIA ng/mL

DRG International, Inc.
Mean −− 0.516 −− 2.33 −− 7.09
SD
CV
1 −−
−−
0.053
10.3
2 −−
−−
0.209
9.0
3 −−
−−
0.709
10.0
# Points −− 81 −− 76 −− 77
# Labs 1 1 1
DYNEX Technologies DS2 • Diagnostics Biochem Canada

Mean 0.150 0.150 1.31 1.38 −− −−
SD
CV
1
0.000
0.0
0.000
0.0
0.000
0.0
2 0.179
13.0
3 −−
−−
−−
−−
# Points 1 1 1 5 −− −−
# Labs 1 1 1 1
Monobind AccuBind
Mean 0.375 0.377 1.50 1.51 4.91 4.97
SD
CV
1
0.071
19.0
0.060
15.9
2 0.213
14.2
0.263
17.4
3 0.819
16.7
0.960
19.3
# Points 14 44 14 44 14 44
# Labs 1 1 1 1 1 1
The statistics in this report are derived from user−supplied data and are provided by Bio−Rad Laboratories as a service to its customers. Such action does not imply support of reported analytes and test methods. Refer to the package
insert for specific analyte claims and stability information. Qualitative percentages may not add up to 100 due to rounding. Peer group statistics contained in this report may not be used without the expressed written consent of Bio−Rad
Laboratories.
Copyright © 2017 Bio−Rad Laboratories, Inc. Generated 29−Aug−2024 17:06:28 Page 1

Worldwide Report July 2024
Immunoassay Plus • Lot 40440 • Exp 28−Feb−2026 Conventional Units
17−Alpha−Hydroxyprogesterone EIA ng/mL

Method Group • EIA
Mean 0.360 0.465 1.49 2.01 4.91 6.32
SD
CV
1 0.090
25.0
0.091
19.5
2 0.211
14.2
0.468
23.3
3 0.819
16.7
1.30
20.6
# Points 15 126 15 125 14 121
# Labs 2 3 2 3 1 2
17−Alpha−Hydroxyprogesterone RIA ng/mL

Beckman Coulter Immunotech
Mean 0.500 0.508 1.68 1.68 4.45 4.51
SD
CV
1 0.000
0.0
0.028
5.5
2 0.046
2.8
0.080
4.8
3 0.316
7.1
0.325
7.2
# Points 8 13 8 13 8 13
# Labs 1 1 1 1 1 1
DIAsource ImmunoAssays
Mean 0.521 0.521 2.29 2.29 4.91 4.91
SD
CV
1 0.026
5.0
0.026
5.0
2 0.126
5.5
0.126
5.5
3 0.303
6.2
0.303
6.2
# Points 10 10 10 10 10 10
# Labs 1 1 1 1 1 1
Method Group • RIA

Mean 0.512 0.514 2.02 1.95 4.71 4.68
SD
CV
1 0.022
4.3
0.027
5.3
2 0.329
16.3
0.323
16.6
3 0.381
8.1
0.370
7.9
# Points 18 23 18 23 18 23
# Labs 2 2 2 2 2 2
25−Hydroxy Vitamin D, Total Chemiluminescence ng/mL

Abbott ARCHITECT/Alinity (c, i, ci models)
Mean 17.82 17.51 25.83 25.07 20.26 19.93
SD
CV
1 1.37
7.7
1.46
8.3
2 1.85
7.2
1.64
6.5
3 1.34
6.6
1.49
7.5
# Points 22 133 37 134 36 90
# Labs 2 4 2 3 2 2
Abbott ARCHITECT/Alinity (c, i, ci models) • Abbott ARCHITECT 25−OH VIT D, REF 3L52
Mean 17.50 17.57 25.12 25.27 19.60 19.60
SD
CV
1 0.000
0.0
0.303
1.7
2
0.760
3.0
0.721
2.9
3 0.710
3.6
0.710
3.6
# Points 1 3 5 7 2 2
# Labs 1 1 1 1 1 1
Abbott ARCHITECT/Alinity (c, i, ci models) • Abbott ARCHITECT 25−OH VIT D, REF 5P02
Mean 18.08 17.20 24.73 24.68 19.17 18.94
SD
CV
1 0.510
2.8
1.12
6.5
2
0.740
3.0
0.836
3.4
3 0.590
3.1
0.794
4.2
# Points 4 12 3 13 3 13
# Labs 1 1 1 1 1 1
Autobio Autolumo Series Analyzers

Mean 21.13 23.20 31.20 34.73 39.99 30.09
SD
CV
1 3.42
16.2
2.75
11.8
2 4.69
15.0
4.37
12.6
3 0.000
0.0
14.01
46.6
# Points 12 50 11 48 1 2
# Labs 3 3 2 3 1 1
Beckman Coulter Access, LXi 725, DxC 600i IA Systems

Mean 18.30 17.31 24.41 23.90 18.25 17.25
SD
CV
1 2.76
15.1
2.85
16.5
2 2.38
9.7
3.62
15.1
3 2.66
14.6
2.89
16.8
# Points 51 158 45 143 37 126
# Labs 6 6 5 5 5 5

25−Hydroxy Vitamin D, Total Chemiluminescence ng/mL

Beckman Coulter UniCel DxI Series
Mean 13.61 15.00 25.91 30.66 −− −−
SD
CV
1 2.11
15.5
2.59
17.2
2 6.37
24.6
8.96
29.2
3 −−
−−
−−
−−
# Points 13 71 21 168 −− −−
# Labs 1 1 2 2
Mindray CL Series
Mean 21.96 22.77 31.96 33.25 21.19 21.80
SD
CV
1 1.79
8.1
2.03
8.9
2 1.66
5.2
2.40
7.2
3 1.17
5.5
1.51
6.9
# Points 32 58 32 58 32 58
# Labs 2 2 2 2 2 2
Siemens ADVIA Centaur Systems

Mean −− −− −− −− 28.10 28.10
SD
CV
1 −−
−−
−−
−−
2 −−
−−
−−
−−
3 3.23
11.5
3.23
11.5
# Points −− −− −− −− 59 59
# Labs 2 2
Siemens Atellica IM Analyzer

Mean 17.97 17.77 32.88 33.05 27.45 26.80
SD
CV
1 2.78
15.5
2.68
15.1
2 2.42
7.4
2.35
7.1
3 2.96
10.8
3.06
11.4
# Points 55 92 26 42 58 90
# Labs 2 2 1 1 2 2

Mean 19.46 18.09 −− 24.12 −− 21.52
SD
CV
1 6.57
33.7
5.24
29.0
2 −−
−−
3.22
13.3
3 −−
−−
3.04
14.1
# Points 5 10 −− 5 −− 4
# Labs 1 2 2 2
VITROS Microwell Series

Mean 30.57 27.75 29.26 27.99 31.52 31.52
SD
CV
1 4.86
15.9
4.11
14.8
2 4.74
16.2
3.45
12.3
3 2.83
9.0
2.83
9.0
# Points 15 67 12 64 2 2
# Labs 2 2 2 2 1 1

Mean 19.49 19.18 27.97 28.33 24.06 21.97
SD
CV
1 4.60
23.6
4.55
23.7
2 4.61
16.5
6.37
22.5
3 4.95
20.6
4.97
22.6
# Points 210 654 192 682 230 446
# Labs 21 24 18 22 17 19
25−Hydroxy Vitamin D, Total Electrochemiluminescence (ECL) ng/mL

Mean −− −− −− 24.52 −− −−
SD
CV
1 −−
−−
−−
−−
2 −−
−−
0.820
3.3
3 −−
−−
−−
−−
# Points −− −− −− 3 −− −−
# Labs 1
Roche cobas 6000/8000/c 311

Mean 11.46 11.76 24.57 24.57 18.60 18.69
SD
CV
1 0.747
6.5
0.942
8.0
2 3.54
14.4
3.91
15.9
3 3.66
19.7
3.97
21.2
# Points 9 32 39 137 39 135
# Labs 1 1 2 2 2 2
Roche cobas e 402/801 • Roche Elecsys Vitamin D total III REF 09038086
Mean 18.88 20.67 20.33 20.16 −− −−
SD
CV
1 1.47
7.8
1.57
7.6
2
1.52
7.5
1.53
7.6
3 −−
−−
−−
−−
# Points 22 93 525 2646 −− −−
# Labs 1 1 6 6

25−Hydroxy Vitamin D, Total Electrochemiluminescence (ECL) ng/mL

Roche Elecsys / cobas e 411 Series
Mean 20.00 19.24 36.78 37.34 17.10 18.00
SD
CV
1 1.66
8.3
2.27
11.8
2 2.46
6.7
4.77
12.8
3 0.000
0.0
1.50
8.3
# Points 5 97 5 63 1 66
# Labs 1 4 1 3 1 2
Roche Elecsys / cobas e 411 Series • Roche Elecsys Vit D REF 06506780
Mean −− 12.94 −− 34.75 −− 18.56
SD
CV
1 −−
−−
6.31
48.8
2
−−
−−
14.61
42.0
3 −−
−−
0.793
4.3
# Points −− 5 −− 3 −− 2
# Labs 2 2 1
Method Group • Electrochemiluminescence (ECL)

Mean 17.18 18.63 20.76 20.77 18.56 18.47
SD
CV
1 3.62
21.1
3.64
19.6
2 2.54
12.2
3.30
15.9
3 3.62
19.5
3.36
18.2
# Points 36 227 569 2852 40 203
# Labs 3 8 9 14 3 5
25−Hydroxy Vitamin D, Total FIA ng/mL

bioMérieux VIDAS Group
Mean −− 20.95 −− 36.35 −− 23.05
SD
CV
1 −−
−−
4.03
19.2
2 −−
−−
7.42
20.4
3 −−
−−
0.210
0.9
# Points −− 2 −− 2 −− 2
# Labs 1 1 1
Method Group • FIA

Mean −− 20.95 −− 36.35 −− 23.05
SD
CV
1 −−
−−
4.03
19.2
2 −−
−−
7.42
20.4
3 −−
−−
0.210
0.9
# Points −− 2 −− 2 −− 2
# Labs 1 1 1
Acetaminophen Chemiluminescence µg/mL

Mean 10.73 9.96 34.59 33.77 107.9 107.2
SD
CV
1 0.000
0.0
0.772
7.7
2 0.000
0.0
1.37
4.1
3 0.000
0.0
3.17
3.0
# Points 1 3 1 3 1 3
# Labs 1 2 1 2 1 2

Mean 10.73 9.96 34.59 33.77 107.9 107.2
SD
CV
1 0.000
0.0
0.772
7.7
2 0.000
0.0
1.37
4.1
3 0.000
0.0
3.17
3.0
# Points 1 3 1 3 1 3
# Labs 1 2 1 2 1 2
Acetaminophen EIA µg/mL

Beckman Coulter AU Series • Emit tox Acetaminophen REF OSR7A229
Mean 11.20 11.20 −− −− 104.0 104.0
SD
CV
1 1.000
8.9
1.000
8.9
−−
−−
2 −−
−−
3 4.00
3.8
4.00
3.8
# Points 30 30 −− −− 43 43
# Labs 1 1 1 1

Mean 9.89 10.34 31.32 32.46 98.40 100.3
SD
CV
1 0.550
5.6
0.436
4.2
2 1.19
3.8
1.16
3.6
3 4.50
4.6
4.21
4.2
# Points 218 1475 217 1474 218 1476
# Labs 4 4 4 4 4 4

Acetaminophen EIA µg/mL

Mean 10.05 10.35 31.32 32.46 99.32 100.4
SD
CV
1 0.752
7.5
0.470
4.5
2 1.19
3.8
1.16
3.6
3 4.88
4.9
4.25
4.2
# Points 248 1505 217 1474 261 1519
# Labs 5 5 4 4 5 5
Acetaminophen Electrochemiluminescence (ECL) µg/mL

Mean −− 10.42 −− 32.24 −− 97.62
SD
CV
1 −−
−−
0.429
4.1
2 −−
−−
0.991
3.1
3 −−
−−
3.26
3.3
# Points −− 47 −− 47 −− 47
# Labs 1 1 1

Mean −− 10.42 −− 32.24 −− 97.62
SD
CV
1 −−
−−
0.429
4.1
2 −−
−−
0.991
3.1
3 −−
−−
3.26
3.3
# Points −− 47 −− 47 −− 47
# Labs 1 1 1
Acetaminophen Enzymatic µg/mL

Abbott ARCHITECT/Alinity (c, i, ci models) • Sekisui Diagnostics SEKURE
Mean 10.66 10.66 35.45 35.09 110.7 109.8
SD
CV
1 0.602
5.6
0.670
6.3
2
0.624
1.8
0.851
2.4
3 1.05
0.9
1.85
1.7
# Points 32 190 31 188 31 187
# Labs 1 1 1 1 1 1
Roche cobas c 303/503

Mean −− 10.97 −− 34.25 −− 102.5
SD
CV
1 −−
−−
0.401
3.7
2 −−
−−
0.923
2.7
3 −−
−−
4.00
3.9
# Points −− 31 −− 31 −− 31
# Labs 1 1 1
Method Group • Enzymatic

Mean 10.66 10.70 35.45 34.97 110.7 108.8
SD
CV
1 0.602
5.6
0.647
6.0
2 0.624
1.8
0.909
2.6
3 1.05
0.9
3.43
3.2
# Points 32 221 31 219 31 218
# Labs 1 2 1 2 1 2
Acetaminophen Enzymatic, colorimetric µg/mL

Mean 10.81 10.78 34.39 34.39 107.7 108.1
SD
CV
1 0.461
4.3
0.489
4.5
2 0.558
1.6
0.558
1.6
3 2.50
2.3
2.32
2.1
# Points 46 74 9 9 46 74
# Labs 3 3 2 2 3 3
Abbott ARCHITECT/Alinity (c, i, ci models) • Sekisui Diagnostics SEKURE

Mean 8.89 10.22 33.00 35.84 105.5 109.2
SD
CV
1 1.20
13.5
0.611
6.0
2
0.949
2.9
1.17
3.3
3 3.02
2.9
2.25
2.1
# Points 13 176 12 176 7 170
# Labs 2 3 2 3 1 3

Mean 10.78 10.58 33.89 33.33 103.3 102.8
SD
CV
1 0.410
3.8
0.415
3.9
2 0.980
2.9
1.00
3.0
3 3.85
3.7
4.27
4.2
# Points 26 73 23 70 26 77
# Labs 1 1 1 1 1 1

Acetaminophen Enzymatic, colorimetric µg/mL

Siemens Dimension Series
Mean 14.59 14.02 −− −− 114.4 114.3
SD
CV
1 2.54
17.4
1.91
13.6
2 −−
−−
−−
−−
3 3.01
2.6
2.80
2.5
# Points 70 327 −− −− 80 312
# Labs 3 4 4 4
VITROS Microslide Series • Slide generation #17

Mean 10.67 10.94 −− 39.38 121.9 123.8
SD
CV
1 0.278
2.6
0.297
2.7
2 −−
−−
0.862
2.2
3 1.81
1.5
2.31
1.9
# Points 40 416 −− 116 42 415
# Labs 2 4 1 2 4
Method Group • Enzymatic, colorimetric

Mean 12.01 11.73 33.75 36.44 112.7 115.9
SD
CV
1 2.53
21.1
1.91
16.2
2 1.02
3.0
2.42
6.7
3 6.78
6.0
7.55
6.5
# Points 195 1066 44 371 201 1048
# Labs 11 15 5 7 11 15
ACTH Chemiluminescence pg/mL

DiaSorin LIAISON/XL
Mean 25.31 24.24 181.2 188.7 229.3 226.0
SD
CV
1 2.91
11.5
3.45
14.2
2 31.20
17.2
28.28
15.0
3 19.51
8.5
22.43
9.9
# Points 14 32 14 32 14 31
# Labs 2 2 2 2 2 2
Mindray CL Series
Mean −− −− 80.76 83.01 −− −−
SD
CV
1 −−
−−
−−
−−
2 8.10
10.0
6.24
7.5
3 −−
−−
−−
−−
# Points −− −− 4 137 −− −−
# Labs 1 1
Siemens IMMULITE 2000/2500/XPi

Mean 28.67 31.45 252.9 274.9 429.4 462.1
SD
CV
1 7.50
26.2
6.10
19.4
2 48.54
19.2
39.96
14.5
3 82.52
19.2
70.72
15.3
# Points 93 387 75 373 73 382
# Labs 8 8 7 8 9 9

Mean 28.23 30.90 234.7 221.3 397.2 444.4
SD
CV
1 7.16
25.4
6.24
20.2
2 61.39
26.2
89.66
40.5
3 106.0
26.7
92.42
20.8
# Points 107 419 93 542 87 413
# Labs 10 10 10 11 11 11
ACTH Electrochemiluminescence (ECL) pg/mL

Mean 10.82 10.54 103.0 93.78 74.41 74.20
SD
CV
1 1.20
11.0
1.02
9.7
2 9.23
9.0
14.17
15.1
3 7.86
10.6
8.23
11.1
# Points 10 51 21 74 21 93
# Labs 2 2 2 2 2 2
Roche cobas e 402/801

Mean 17.07 16.79 122.2 122.2 88.55 85.26
SD
CV
1 0.896
5.2
1.33
7.9
2 9.83
8.0
9.83
8.0
3 21.01
23.7
18.59
21.8
# Points 33 76 6 6 32 78
# Labs 2 2 1 1 2 2

ACTH Electrochemiluminescence (ECL) pg/mL

Roche cobas e 402/801 • Roche Elecsys ACTH, REF 08946728
Mean 17.95 17.39 92.56 93.90 −− −−
SD
CV
1 1.14
6.3
1.44
8.3
4.37
4.7
2 5.84
6.2
3 −−
−−
−−
−−
# Points 4 12 5 13 −− −−
# Labs 1 1 1 1

Mean −− −− 144.4 140.0 −− −−
SD
CV
1 −−
−−
−−
−−
2 14.41
10.0
15.04
10.7
3 −−
−−
−−
−−
# Points −− −− 21 70 −− −−
# Labs 1 1

Mean 15.82 14.55 120.6 114.7 82.95 79.24
SD
CV
1 2.81
17.7
3.30
22.7
2 23.54
19.5
26.56
23.2
3 18.32
22.1
14.96
18.9
# Points 47 139 53 163 53 171
# Labs 5 5 5 5 4 4
AFP Chemiluminescence IU/mL

Mean 13.70 13.87 75.74 76.00 213.5 212.4
SD
CV
1 0.570
4.2
0.718
5.2
2 3.29
4.3
3.42
4.5
3 8.85
4.1
8.92
4.2
# Points 297 1061 274 983 227 840
# Labs 15 18 14 18 14 17
Abbott ARCHITECT/Alinity (c, i, ci models) • Abbott ARCHITECT AFP (3P36)

Mean 13.86 13.82 76.41 75.30 210.5 210.4
SD
CV
1 0.556
4.0
0.531
3.8
2
3.16
4.1
3.68
4.9
3 8.07
3.8
8.00
3.8
# Points 70 236 62 210 78 244
# Labs 5 6 5 6 5 6
Abbott ARCHITECT/Alinity (c, i, ci models) • Abbott ARCHITECT AFP (7K67)

Mean 13.94 14.20 81.20 81.28 236.0 238.5
SD
CV
1 1.06
7.6
1.07
7.6
2
2.44
3.0
3.11
3.8
3 8.59
3.6
9.08
3.8
# Points 9 14 9 13 8 11
# Labs 1 1 1 1 1 1

Mean 14.45 14.51 74.94 76.51 215.2 217.8
SD
CV
1 1.32
9.2
1.44
9.9
2 5.63
7.5
7.39
9.7
3 17.93
8.3
22.40
10.3
# Points 113 273 115 266 110 271
# Labs 8 8 7 7 7 7

Mean 13.70 13.34 71.15 69.52 201.7 198.3
SD
CV
1 1.21
8.8
1.15
8.6
2 6.36
8.9
5.75
8.3
3 16.75
8.3
16.82
8.5
# Points 273 912 273 835 335 1095
# Labs 19 19 19 19 20 20
Siemens ADVIA Centaur CP

Mean 15.64 15.08 78.84 77.31 225.6 220.2
SD
CV
1 1.32
8.5
1.62
10.8
2 6.13
7.8
8.10
10.5
3 20.05
8.9
20.68
9.4
# Points 44 141 44 145 47 148
# Labs 3 3 3 3 3 3

Mean 15.81 15.99 80.65 80.88 226.9 225.9
SD
CV
1 1.27
8.0
1.18
7.4
2 5.78
7.2
5.10
6.3
3 17.29
7.6
19.18
8.5
# Points 149 634 156 614 151 498
# Labs 8 12 9 12 9 9

AFP Chemiluminescence IU/mL

Mean 15.60 15.77 80.77 81.07 230.2 231.2
SD
CV
1 0.919
5.9
0.963
6.1
2 3.99
4.9
3.76
4.6
3 11.70
5.1
11.32
4.9
# Points 320 1397 323 1334 317 1319
# Labs 11 11 11 11 11 11
Siemens Dimension Vista

Mean 15.12 14.97 78.99 78.33 228.0 225.5
SD
CV
1 0.235
1.6
0.404
2.7
2 1.50
1.9
2.05
2.6
3 4.95
2.2
7.43
3.3
# Points 25 36 25 36 25 36
# Labs 1 1 1 1 1 1

Mean 14.13 14.26 75.82 76.74 213.5 220.1
SD
CV
1 1.35
9.6
1.30
9.1
2 6.68
8.8
6.84
8.9
3 21.58
10.1
20.14
9.1
# Points 195 492 210 495 132 349
# Labs 13 14 13 14 10 11

Mean 14.65 14.47 61.05 70.40 213.3 212.2
SD
CV
1 0.479
3.3
0.627
4.3
2 37.50
61.4
21.23
30.2
3 7.92
3.7
17.97
8.5
# Points 4 9 4 12 3 9
# Labs 2 2 2 2 1 2

Mean 13.69 13.72 71.64 71.50 201.7 202.5
SD
CV
1 1.02
7.4
1.09
7.9
2 5.37
7.5
5.64
7.9
3 16.58
8.2
17.13
8.5
# Points 421 1903 430 1916 403 1893
# Labs 23 23 23 23 22 22

Mean 14.34 14.40 75.51 75.47 213.3 212.8
SD
CV
1 1.34
9.4
1.44
10.0
2 6.56
8.7
6.75
8.9
3 19.05
8.9
19.88
9.3
# Points 1920 7108 1925 6859 1836 6713
# Labs 109 118 108 117 104 110
AFP Chemiluminescence ng/mL

Mean 16.51 16.71 91.26 91.56 257.2 255.9
SD
CV
1 0.687
4.2
0.865
5.2
2 3.96
4.3
4.12
4.5
3 10.67
4.1
10.75
4.2
# Points 297 1061 274 983 227 840
# Labs 15 18 14 18 14 17
Abbott ARCHITECT/Alinity (c, i, ci models) • Abbott ARCHITECT AFP (3P36)

Mean 16.70 16.65 92.06 90.73 253.6 253.5
SD
CV
1 0.669
4.0
0.640
3.8
2
3.81
4.1
4.44
4.9
3 9.72
3.8
9.63
3.8
# Points 70 236 62 210 78 244
# Labs 5 6 5 6 5 6
Abbott ARCHITECT/Alinity (c, i, ci models) • Abbott ARCHITECT AFP (7K67)

Mean 16.79 17.11 97.83 97.93 284.4 287.4
SD
CV
1 1.28
7.6
1.29
7.6
2
2.94
3.0
3.75
3.8
3 10.35
3.6
10.94
3.8
# Points 9 14 9 13 8 11
# Labs 1 1 1 1 1 1

Mean 17.41 17.49 90.29 92.18 259.2 262.4
SD
CV
1 1.60
9.2
1.73
9.9
2 6.79
7.5
8.90
9.7
3 21.60
8.3
26.98
10.3
# Points 113 273 115 266 110 271
# Labs 8 8 7 7 7 7

AFP Chemiluminescence ng/mL

Mean 16.51 16.07 85.72 83.76 243.0 238.9
SD
CV
1 1.45
8.8
1.39
8.6
2 7.67
8.9
6.93
8.3
3 20.18
8.3
20.27
8.5
# Points 273 912 273 835 335 1095
# Labs 19 19 19 19 20 20

Mean 18.84 18.17 94.99 93.14 271.8 265.3
SD
CV
1 1.60
8.5
1.96
10.8
2 7.39
7.8
9.76
10.5
3 24.15
8.9
24.91
9.4
# Points 44 141 44 145 47 148
# Labs 3 3 3 3 3 3

Mean 19.05 19.26 97.17 97.45 273.4 272.2
SD
CV
1 1.53
8.0
1.42
7.4
2 6.96
7.2
6.14
6.3
3 20.83
7.6
23.10
8.5
# Points 149 634 156 614 151 498
# Labs 8 12 9 12 9 9

Mean 18.79 19.00 97.31 97.67 277.3 278.5
SD
CV
1 1.11
5.9
1.16
6.1
2 4.81
4.9
4.53
4.6
3 14.09
5.1
13.63
4.9
# Points 320 1397 323 1334 317 1319
# Labs 11 11 11 11 11 11

Mean 18.22 18.04 95.16 94.38 274.7 271.6
SD
CV
1 0.283
1.6
0.487
2.7
2 1.80
1.9
2.47
2.6
3 5.96
2.2
8.95
3.3
# Points 25 36 25 36 25 36
# Labs 1 1 1 1 1 1

Mean 17.02 17.18 91.35 92.45 257.2 265.2
SD
CV
1 1.63
9.6
1.57
9.1
2 8.05
8.8
8.24
8.9
3 26.00
10.1
24.26
9.1
# Points 195 492 210 495 132 349
# Labs 13 14 13 14 10 11

Mean 17.65 17.44 73.55 84.82 257.0 255.7
SD
CV
1 0.578
3.3
0.756
4.3
2 45.18
61.4
25.58
30.2
3 9.54
3.7
21.65
8.5
# Points 4 9 4 12 3 9
# Labs 2 2 2 2 1 2

Mean 16.49 16.53 86.31 86.15 243.0 244.0
SD
CV
1 1.23
7.4
1.31
7.9
2 6.47
7.5
6.80
7.9
3 19.97
8.2
20.64
8.5
# Points 421 1903 430 1916 403 1893
# Labs 23 23 23 23 22 22

Mean 17.27 17.36 90.97 90.93 257.0 256.4
SD
CV
1 1.62
9.4
1.73
10.0
2 7.91
8.7
8.13
8.9
3 22.95
8.9
23.95
9.3
# Points 1920 7108 1925 6859 1836 6713
# Labs 109 118 108 117 104 110
AFP EIA IU/mL

DiaSorin LIAISON/XL
Mean 16.74 16.69 82.18 81.69 248.2 246.7
SD
CV
1 0.874
5.2
1.02
6.1
2 3.69
4.5
3.31
4.1
3 11.06
4.5
10.42
4.2
# Points 27 42 24 37 25 38
# Labs 1 1 1 1 1 1

AFP EIA IU/mL

Tosoh AIA Models
Mean 13.66 13.66 73.83 73.83 209.4 209.4
SD
CV
1 0.314
2.3
0.314
2.3
2 0.176
0.2
0.176
0.2
3 5.58
2.7
5.58
2.7
# Points 10 10 2 2 10 10
# Labs 1 1 1 1 1 1

Mean 15.91 16.11 81.53 81.28 237.1 238.9
SD
CV
1 1.58
9.9
1.52
9.4
2 4.21
5.2
3.67
4.5
3 20.28
8.6
18.05
7.6
# Points 37 52 26 39 35 48
# Labs 2 2 2 2 2 2
AFP EIA ng/mL

DiaSorin LIAISON/XL
Mean 20.17 20.11 99.01 98.42 299.1 297.2
SD
CV
1 1.05
5.2
1.22
6.1
2 4.45
4.5
3.99
4.1
3 13.33
4.5
12.55
4.2
# Points 27 42 24 37 25 38
# Labs 1 1 1 1 1 1
Tosoh AIA Models

Mean 16.46 16.46 88.95 88.95 252.3 252.3
SD
CV
1 0.378
2.3
0.378
2.3
2 0.212
0.2
0.212
0.2
3 6.73
2.7
6.73
2.7
# Points 10 10 2 2 10 10
# Labs 1 1 1 1 1 1

Mean 19.17 19.41 98.23 97.93 285.7 287.9
SD
CV
1 1.90
9.9
1.83
9.4
2 5.07
5.2
4.42
4.5
3 24.44
8.6
21.75
7.6
# Points 37 52 26 39 35 48
# Labs 2 2 2 2 2 2
AFP Electrochemiluminescence (ECL) IU/mL

Mean 14.89 15.05 79.53 77.50 223.8 214.0
SD
CV
1 0.924
6.2
2.46
16.4
2 6.73
8.5
8.41
10.8
3 19.36
8.7
24.00
11.2
# Points 181 889 206 987 197 733
# Labs 10 16 11 18 10 15
Roche cobas 6000/8000/c 311 • Roche Elecsys AFP, REF 09015124

Mean 15.19 15.19 83.21 82.83 235.0 232.9
SD
CV
1 0.504
3.3
0.481
3.2
2
1.95
2.3
2.13
2.6
3 5.27
2.2
6.87
2.9
# Points 36 79 36 69 37 65
# Labs 2 2 2 2 2 2
Roche cobas c 303/503 • Roche Elecsys AFP, REF 09015124

Mean 15.49 15.33 85.08 84.38 239.2 237.4
SD
CV
1 0.301
1.9
0.377
2.5
2
1.58
1.9
2.16
2.6
3 4.15
1.7
5.78
2.4
# Points 27 56 27 56 27 58
# Labs 1 1 1 1 1 1

Mean 15.50 15.47 83.91 82.28 237.4 238.2
SD
CV
1 0.879
5.7
0.870
5.6
2 7.34
8.8
9.51
11.6
3 14.50
6.1
13.86
5.8
# Points 220 600 86 271 194 514
# Labs 10 12 7 9 10 12

AFP Electrochemiluminescence (ECL) IU/mL

Roche cobas e 402/801 • Roche Elecsys AFP, REF 09015124
Mean 15.23 15.23 83.17 83.17 235.7 235.7
SD
CV
1 0.257
1.7
0.257
1.7
1.54
1.8
2 1.54
1.8
3 4.16
1.8
4.16
1.8
# Points 20 20 20 20 19 19
# Labs 1 1 1 1 1 1

Mean 14.87 14.22 78.02 75.48 218.7 206.8
SD
CV
1 2.18
14.7
3.32
23.3
2 8.81
11.3
8.28
11.0
3 31.82
14.6
29.18
14.1
# Points 126 421 124 401 91 215
# Labs 10 13 9 11 7 10

Mean 15.16 15.02 80.62 78.25 229.5 222.7
SD
CV
1 1.27
8.4
2.30
15.3
2 7.31
9.1
8.63
11.0
3 20.65
9.0
24.52
11.0
# Points 610 2065 499 1804 565 1604
# Labs 34 45 31 42 31 41
AFP Electrochemiluminescence (ECL) ng/mL

Mean 17.94 18.13 95.82 93.38 269.6 257.8
SD
CV
1 1.11
6.2
2.97
16.4
2 8.11
8.5
10.13
10.8
3 23.33
8.7
28.92
11.2
# Points 181 889 206 987 197 733
# Labs 10 16 11 18 10 15
Roche cobas 6000/8000/c 311 • Roche Elecsys AFP, REF 09015124

Mean 18.30 18.31 100.3 99.79 283.1 280.6
SD
CV
1 0.607
3.3
0.580
3.2
2.35
2.3
22.56
2.6
3 6.35
2.2
8.28
2.9
# Points 36 79 36 69 37 65
# Labs 2 2 2 2 2 2
Roche cobas c 303/503 • Roche Elecsys AFP, REF 09015124

Mean 18.66 18.47 102.5 101.7 288.2 286.0
SD
CV
1 0.363
1.9
0.454
2.5
1.90
1.9
2 2.60
2.6
3 5.00
1.7
6.96
2.4
# Points 27 56 27 56 27 58
# Labs 1 1 1 1 1 1

Mean 18.68 18.64 101.1 99.14 286.0 287.0
SD
CV
1 1.06
5.7
1.05
5.6
2 8.85
8.8
11.46
11.6
3 17.47
6.1
16.70
5.8
# Points 220 600 86 271 194 514
# Labs 10 12 7 9 10 12
Roche cobas e 402/801 • Roche Elecsys AFP, REF 09015124

Mean 18.35 18.35 100.2 100.2 284.0 284.0
SD
CV
1 0.310
1.7
0.310
1.7
1.85
1.8
2 1.85
1.8
3 5.01
1.8
5.01
1.8
# Points 20 20 20 20 19 19
# Labs 1 1 1 1 1 1

Mean 17.92 17.14 94.00 90.94 263.5 249.2
SD
CV
1 2.63
14.7
4.00
23.3
2 10.61
11.3
9.98
11.0
3 38.34
14.6
35.15
14.1
# Points 126 421 124 401 91 215
# Labs 10 13 9 11 7 10

Mean 18.27 18.09 97.14 94.28 276.5 268.3
SD
CV
1 1.53
8.4
2.77
15.3
2 8.80
9.1
10.40
11.0
3 24.88
9.0
29.54
11.0
# Points 610 2065 499 1804 565 1604
# Labs 34 45 31 42 31 41

AFP FIA IU/mL

Mean 13.85 14.87 76.46 79.84 228.6 233.0
SD
CV
1 0.697
5.0
1.95
13.1
2 4.31
5.6
7.85
9.8
3 24.29
10.6
28.47
12.2
# Points 6 9 6 14 11 15
# Labs 2 2 2 3 3 3

Mean 13.85 14.87 76.46 79.84 228.6 233.0
SD
CV
1 0.697
5.0
1.95
13.1
2 4.31
5.6
7.85
9.8
3 24.29
10.6
28.47
12.2
# Points 6 9 6 14 11 15
# Labs 2 2 2 3 3 3
AFP FIA ng/mL

Mean 16.68 17.91 92.12 96.19 275.4 280.7
SD
CV
1 0.840
5.0
2.35
13.1
2 5.19
5.6
9.46
9.8
3 29.26
10.6
34.30
12.2
# Points 6 9 6 14 11 15
# Labs 2 2 2 3 3 3

Mean 16.68 17.91 92.12 96.19 275.4 280.7
SD
CV
1 0.840
5.0
2.35
13.1
2 5.19
5.6
9.46
9.8
3 29.26
10.6
34.30
12.2
# Points 6 9 6 14 11 15
# Labs 2 2 2 3 3 3
AFP RIA IU/mL

VITROS Microtip Series
Mean −− 13.49 −− 71.02 −− 203.1
SD
CV
1 −−
−−
0.390
2.9
2 −−
−−
2.02
2.8
3 −−
−−
10.81
5.3
# Points −− 12 −− 12 −− 13
# Labs 1 1 1

Mean −− 13.49 −− 71.02 −− 203.1
SD
CV
1 −−
−−
0.390
2.9
2 −−
−−
2.02
2.8
3 −−
−−
10.81
5.3
# Points −− 12 −− 12 −− 13
# Labs 1 1 1
AFP RIA ng/mL

Mean −− 16.25 −− 85.57 −− 244.6
SD
CV
1 −−
−−
0.470
2.9
2 −−
−−
2.43
2.8
3 −−
−−
13.02
5.3
# Points −− 12 −− 12 −− 13
# Labs 1 1 1

Mean −− 16.25 −− 85.57 −− 244.6
SD
CV
1 −−
−−
0.470
2.9
2 −−
−−
2.43
2.8
3 −−
−−
13.02
5.3
# Points −− 12 −− 12 −− 13
# Labs 1 1 1
Aldosterone Chemiluminescence pg/mL

DiaSorin
Mean 122.9 109.7 274.3 254.4 −− −−
SD
CV
1 5.90
4.8
10.59
9.7
2 7.70
2.8
22.24
8.7
3 −−
−−
−−
−−
# Points 10 49 10 48 −− −−
# Labs 1 1 1 1

Aldosterone Chemiluminescence pg/mL

DiaSorin LIAISON/XL
Mean 125.2 125.1 272.3 269.6 630.0 623.8
SD
CV
1 11.35
9.1
11.43
9.1
2 21.58
7.9
23.17
8.6
3 48.03
7.6
52.91
8.5
# Points 26 78 26 78 26 78
# Labs 1 1 1 1 1 1
IDS iSYS
Mean 166.2 165.6 320.7 321.1 756.8 750.7
SD
CV
1 4.62
2.8
4.01
2.4
2 13.94
4.3
11.00
3.4
3 44.16
5.8
36.09
4.8
# Points 6 10 6 10 6 10
# Labs 1 1 1 1 1 1
Mindray CL Series
Mean 133.5 133.5 373.0 369.9 900.6 886.9
SD
CV
1 6.48
4.9
6.21
4.7
2 9.45
2.5
11.04
3.0
3 17.43
1.9
22.25
2.5
# Points 54 242 54 242 54 242
# Labs 1 1 1 1 1 1

Mean 133.1 130.7 278.9 270.7 771.2 753.3
SD
CV
1 7.88
5.9
11.02
8.4
2 32.55
11.7
26.61
9.8
3 123.1
16.0
115.2
15.3
# Points 131 635 129 632 141 720
# Labs 5 6 5 6 7 7
Snibe MAGLUMI Series • Snibe MAGLUMI Aldosterone REF 130X56007M

Mean 137.6 137.6 287.4 287.4 804.4 804.4
SD
CV
1 4.31
3.1
4.31
3.1
14.69
5.1
2
14.69
5.1
3 59.57
7.4
59.57
7.4
# Points 15 15 14 14 14 14
# Labs 1 1 1 1 1 1

Mean 133.0 130.4 300.8 294.0 786.6 774.9
SD
CV
1 9.92
7.5
11.71
9.0
2 47.31
15.7
48.56
16.5
3 123.1
15.6
119.2
15.4
# Points 242 1029 239 1024 241 1064
# Labs 10 11 10 11 11 11
Amikacin Immunoturbidimetric µg/mL

Mean 4.88 4.84 13.73 13.60 25.70 25.74
SD
CV
1 0.160
3.3
0.237
4.9
2 0.168
1.2
0.324
2.4
3 0.411
1.6
0.587
2.3
# Points 39 183 37 176 38 185
# Labs 2 2 2 2 2 2

Mean 4.74 4.57 12.66 12.76 24.38 24.90
SD
CV
1 0.110
2.3
0.262
5.7
2 0.283
2.2
0.400
3.1
3 0.596
2.4
0.922
3.7
# Points 6 30 6 30 6 30
# Labs 1 1 1 1 1 1
Method Group • Immunoturbidimetric

Mean 4.87 4.80 13.58 13.48 25.52 25.62
SD
CV
1 0.160
3.3
0.257
5.3
2 0.415
3.1
0.448
3.3
3 0.629
2.5
0.704
2.7
# Points 45 213 43 206 44 215
# Labs 3 3 3 3 3 3

Amikacin KIMS (Roche) µg/mL

Mean 4.87 4.86 13.72 13.77 26.28 26.07
SD
CV
1 0.271
5.6
0.253
5.2
2 0.439
3.2
0.458
3.3
3 0.685
2.6
0.676
2.6
# Points 128 479 120 471 126 473
# Labs 5 5 4 4 5 5

Mean 5.34 5.34 −− 14.24 26.22 25.77
SD
CV
1 0.278
5.2
0.318
6.0
2 −−
−−
0.368
2.6
3 0.696
2.7
0.845
3.3
# Points 32 89 −− 32 32 87
# Labs 1 2 1 1 2
Method Group • KIMS (Roche)

Mean 4.97 4.93 13.72 13.80 26.27 26.03
SD
CV
1 0.330
6.7
0.318
6.4
2 0.439
3.2
0.467
3.4
3 0.685
2.6
0.713
2.7
# Points 160 568 120 503 158 560
# Labs 6 7 4 5 6 7
Androstenedione Chemiluminescence ng/mL

DiaSorin LIAISON/XL
Mean 0.676 0.673 1.51 1.47 3.07 3.02
SD
CV
1 0.117
17.3
0.119
17.7
2 0.128
8.5
0.131
8.9
3 0.237
7.7
0.236
7.8
# Points 42 100 42 100 42 100
# Labs 3 3 3 3 3 3

Mean 0.955 1.03 2.87 3.02 6.08 3.51
SD
CV
1 0.203
21.3
0.247
24.0
2 0.418
14.6
0.457
15.2
3 0.536
8.8
3.13
89.1
# Points 162 470 168 543 40 145
# Labs 12 13 13 14 7 10
Siemens IMMULITE/1000
Mean 1.39 1.39 3.35 3.35 −− −−
SD
CV
1 0.290
20.9
0.290
20.9
2 0.060
1.8
0.060
1.8
3 −−
−−
−−
−−
# Points 2 2 2 2 −− −−
# Labs 1 1 1 1

Mean 0.708 0.724 2.22 2.24 4.16 4.22
SD
CV
1 0.057
8.1
0.052
7.2
2 0.062
2.8
0.064
2.9
3 0.063
1.5
0.087
2.1
# Points 93 471 93 466 93 473
# Labs 2 2 2 2 2 2
YHLO iFlash 3000

Mean 1.10 1.13 1.69 1.73 3.55 3.60
SD
CV
1 0.030
2.7
0.037
3.2
2 0.050
3.0
0.058
3.3
3 0.070
2.0
0.099
2.8
# Points 28 123 28 123 28 123
# Labs 1 1 1 1 1 1

Mean 0.864 0.886 2.42 2.47 4.23 3.86
SD
CV
1 0.213
24.7
0.237
26.8
2 0.599
24.8
0.618
25.0
3 1.05
24.7
1.37
35.5
# Points 327 1166 333 1234 203 841
# Labs 19 20 20 21 13 16

C−Peptide Chemiluminescence ng/mL

Mean 1.08 1.06 6.41 6.29 9.26 9.08
SD
CV
1 0.052
4.8
0.063
5.9
2 0.281
4.4
0.325
5.2
3 0.401
4.3
0.477
5.3
# Points 441 1391 479 1482 356 1328
# Labs 16 17 16 17 12 13

Mean 0.761 0.766 4.06 4.17 6.13 6.25
SD
CV
1 0.054
7.1
0.057
7.5
2 0.344
8.5
0.307
7.4
3 0.355
5.8
0.353
5.7
# Points 114 204 190 502 181 430
# Labs 7 7 10 10 9 9
Beckman Coulter UniCel DxI Series • Alternate Formulation/Standardization

Mean −− −− −− 5.33 −− 8.27
SD
CV
1 −−
−−
−−
−−
−−
−−
2 0.037
0.7
3 −−
−−
0.060
0.7
# Points −− −− −− 4 −− 4
# Labs 2 2
DiaSorin
Mean −− −− −− 8.08 −− 10.09
SD
CV
1 −−
−−
−−
−−
2 −−
−−
0.000
0.0
3 −−
−−
0.000
0.0
# Points −− −− −− 1 −− 1
# Labs 1 1
DiaSorin LIAISON/XL
Mean 1.35 1.35 7.06 6.99 9.96 9.94
SD
CV
1 0.080
6.0
0.091
6.8
2 0.471
6.7
0.457
6.5
3 0.585
5.9
0.549
5.5
# Points 33 73 33 73 33 73
# Labs 3 3 3 3 3 3
Mindray CL Series
Mean 0.883 0.898 5.79 4.80 8.65 8.75
SD
CV
1 0.026
2.9
0.036
4.0
2 0.246
4.2
1.86
38.9
3 0.375
4.3
0.389
4.4
# Points 59 234 59 333 58 161
# Labs 2 4 2 5 2 3

Mean 1.00 0.996 5.41 5.39 7.89 7.99
SD
CV
1 0.020
2.0
0.017
1.7
2 0.280
5.2
0.289
5.4
3 0.210
2.7
0.196
2.5
# Points 3 5 3 10 3 6
# Labs 1 1 1 1 1 1

Mean 0.933 0.956 5.19 5.36 7.75 7.74
SD
CV
1 0.096
10.3
0.100
10.4
2 0.531
10.2
0.443
8.3
3 0.587
7.6
0.565
7.3
# Points 206 858 208 815 134 511
# Labs 9 13 9 14 7 9

Mean 0.937 0.957 4.98 5.38 7.39 7.69
SD
CV
1 0.133
14.2
0.074
7.8
2 0.203
4.1
0.296
5.5
3 0.277
3.8
0.378
4.9
# Points 38 341 21 182 18 89
# Labs 4 5 2 3 2 2

Mean 0.909 0.920 6.07 6.27 8.79 9.20
SD
CV
1 0.032
3.5
0.037
4.0
2 0.248
4.1
0.305
4.9
3 0.391
4.5
0.519
5.6
# Points 28 208 29 206 28 211
# Labs 2 3 2 3 2 3

C−Peptide Chemiluminescence ng/mL

Mean −− 1.65 9.40 7.82 13.80 12.80
SD
CV
1 −−
−−
0.361
21.8
2 0.000
0.0
1.63
20.9
3 0.000
0.0
1.41
11.0
# Points −− 2 1 3 1 2
# Labs 1 1 1 1 1

Mean 1.09 1.10 6.54 6.49 9.24 9.17
SD
CV
1 0.057
5.2
0.068
6.2
2 0.219
3.4
0.221
3.4
3 0.241
2.6
0.261
2.8
# Points 50 143 50 143 51 144
# Labs 2 2 2 2 2 2

Mean 0.997 0.996 5.71 5.64 8.30 8.41
SD
CV
1 0.144
14.4
0.123
12.4
2 0.996
17.4
1.03
18.2
3 1.35
16.3
1.16
13.8
# Points 972 3460 1073 3750 863 2956
# Labs 46 57 48 60 41 47
C−Peptide EIA ng/mL

Tosoh AIA Models
Mean 1.03 1.05 5.97 6.44 8.95 9.22
SD
CV
1 0.100
9.7
0.084
8.0
2 0.200
3.4
0.527
8.2
3 0.550
6.1
0.542
5.9
# Points 4 7 3 6 3 6
# Labs 1 1 1 1 1 1

Mean 1.03 1.05 5.97 6.44 8.95 9.22
SD
CV
1 0.100
9.7
0.084
8.0
2 0.200
3.4
0.527
8.2
3 0.550
6.1
0.542
5.9
# Points 4 7 3 6 3 6
# Labs 1 1 1 1 1 1
C−Peptide Electrochemiluminescence (ECL) ng/mL

Mean 1.40 1.43 6.62 6.58 9.39 9.39
SD
CV
1 0.230
16.4
0.279
19.5
2 0.311
4.7
0.296
4.5
3 0.517
5.5
0.488
5.2
# Points 275 1038 271 1167 209 940
# Labs 14 15 16 17 12 12
Roche cobas c 303/503 • Roche Elecsys C−Peptide REF 07027168

Mean 1.27 1.31 6.55 6.68 9.48 9.72
SD
CV
1 0.031
2.4
0.031
2.4
2
0.072
1.1
0.216
3.2
3 0.082
0.9
0.339
3.5
# Points 4 15 4 16 4 16
# Labs 1 1 1 1 1 1

Mean 1.29 1.27 6.50 6.31 9.35 9.26
SD
CV
1 0.057
4.4
0.064
5.0
2 0.202
3.1
0.251
4.0
3 0.396
4.2
0.395
4.3
# Points 120 377 35 158 114 363
# Labs 7 8 4 5 6 7
Roche cobas e 402/801 • Roche Elecsys Ferritin, REF 07027273

Mean 1.28 1.28 6.62 6.62 9.58 9.58
SD
CV
1 0.006
0.4
0.006
0.4
2
0.042
0.6
0.042
0.6
3 0.000
0.0
0.000
0.0
# Points 3 3 2 2 1 1
# Labs 1 1 1 1 1 1

C−Peptide Electrochemiluminescence (ECL) ng/mL

Roche cobas e 402/801 • Roche e 801 C−Peptide, REF 07027168
Mean 1.26 1.28 6.43 6.46 −− −−
SD
CV
1 0.045
3.6
0.032
2.5
0.111
1.7
2 0.109
1.7
3 −−
−−
−−
−−
# Points 14 47 14 47 −− −−
# Labs 1 1 1 1
Roche cobas u 601

Mean 1.32 1.35 6.51 6.68 9.47 9.68
SD
CV
1 0.030
2.3
0.040
2.9
2 0.290
4.5
0.293
4.4
3 0.100
1.1
0.236
2.4
# Points 7 14 8 15 7 14
# Labs 1 1 1 1 1 1

Mean 1.24 1.28 6.17 6.37 9.05 9.19
SD
CV
1 0.097
7.8
0.082
6.4
2 0.450
7.3
0.338
5.3
3 0.335
3.7
0.413
4.5
# Points 28 99 26 101 30 96
# Labs 3 5 3 5 2 4
YHLO iFlash 3000

Mean −− −− 7.19 7.19 10.30 10.30
SD
CV
1 −−
−−
−−
−−
2 0.151
2.1
0.151
2.1
3 0.242
2.3
0.242
2.3
# Points −− −− 34 34 34 34
# Labs 1 1 1 1

Mean 1.35 1.38 6.62 6.55 9.43 9.37
SD
CV
1 0.193
14.3
0.241
17.5
2 0.362
5.5
0.318
4.8
3 0.525
5.6
0.483
5.2
# Points 451 1593 394 1540 399 1464
# Labs 28 32 28 32 24 27
Calcitonin Chemiluminescence ng/mL

Beckman Coulter UniCel DxI Series • Beckman Coulter Access/DxI Folate (REF A98032)
Mean −− −− 106.5 82.48 −− −−
SD
CV
1 −−
−−
−−
−−
0.000
0.0
2 21.52
26.1
3 −−
−−
−−
−−
# Points −− −− 1 30 −− −−
# Labs 1 1
DiaSorin LIAISON/XL
Mean 0.054 0.054 0.188 0.188 0.386 0.386
SD
CV
1 0.003
5.4
0.003
5.4
2 0.001
0.4
0.001
0.4
3 0.001
0.4
0.001
0.4
# Points 2 2 2 2 2 2
# Labs 1 1 1 1 1 1
Roche cobas u 601

Mean −− 0.046 −− 0.228 −− −−
SD
CV
1 −−
−−
0.003
6.1
2 −−
−−
0.015
6.6
3 −−
−−
−−
−−
# Points −− 54 −− 54 −− −−
# Labs 1 1

Mean 0.063 0.063 0.209 0.209 0.432 0.434
SD
CV
1 0.006
9.7
0.006
9.2
2 0.010
4.9
0.009
4.5
3 0.026
6.0
0.026
5.9
# Points 112 377 71 290 77 326
# Labs 5 7 3 5 4 6

Mean 0.069 0.072 0.240 0.235 0.532 0.535
SD
CV
1 0.007
10.4
0.007
9.8
2 0.013
5.6
0.014
6.0
3 0.024
4.5
0.023
4.3
# Points 45 123 60 211 46 121
# Labs 3 4 4 5 3 4

Calcitonin Chemiluminescence ng/mL

Mean 0.064 0.064 1.02 4.42 0.468 0.461
SD
CV
1 0.007
11.0
0.009
14.2
2 9.18
903.8
18.75
423.8
3 0.055
11.8
0.051
11.1
# Points 159 556 134 587 125 449
# Labs 9 13 9 13 8 11
Calcitonin Chemiluminescence pg/mL

Mean −− −− 106500 82476 −− −−
SD
CV
1 −−
−−
−−
−−
2
0.000 21524
0.0 26.1
3 −−
−−
−−
−−
# Points −− −− 1 30 −− −−
# Labs 1 1
DiaSorin LIAISON/XL
Mean 54.05 54.05 187.5 187.5 386.0 386.0
SD
CV
1 2.90
5.4
2.90
5.4
2 0.707
0.4
0.707
0.4
3 1.41
0.4
1.41
0.4
# Points 2 2 2 2 2 2
# Labs 1 1 1 1 1 1
Roche cobas u 601

Mean −− 45.66 −− 228.3 −− −−
SD
CV
1 −−
−−
2.80
6.1
2 −−
−−
14.98
6.6
3 −−
−−
−−
−−
# Points −− 54 −− 54 −− −−
# Labs 1 1

Mean 62.72 63.47 209.4 209.4 431.7 433.9
SD
CV
1 6.06
9.7
5.81
9.2
2 10.15
4.9
9.43
4.5
3 25.92
6.0
25.56
5.9
# Points 112 377 71 290 77 326
# Labs 5 7 3 5 4 6

Mean 69.19 71.80 239.7 235.0 531.5 534.5
SD
CV
1 7.20
10.4
7.05
9.8
2 13.38
5.6
14.19
6.0
3 24.13
4.5
22.83
4.3
# Points 45 123 60 211 46 121
# Labs 3 4 4 5 3 4

Mean 64.44 63.55 1016 4425 467.7 460.8
SD
CV
1 7.08
11.0
9.01
14.2
2 9181
903.8
18751
423.8
3 55.21
11.8
51.30
11.1
# Points 159 556 134 587 125 449
# Labs 9 13 9 13 8 11
Calcitonin Electrochemiluminescence (ECL) ng/mL

Mean 0.060 0.061 0.206 0.214 0.418 0.413
SD
CV
1 0.005
8.8
0.006
9.1
2 0.023
11.3
0.016
7.2
3 0.035
8.4
0.058
14.0
# Points 18 117 17 114 6 8
# Labs 5 5 5 5 3 3

Mean 0.062 0.061 −− −− 0.385 0.385
SD
CV
1 0.002
3.3
0.005
7.6
2 −−
−−
−−
−−
3 0.000
0.0
0.000
0.0
# Points 28 49 −− −− 1 1
# Labs 1 1 1 1

Calcitonin Electrochemiluminescence (ECL) ng/mL

Mean 0.061 0.061 0.206 0.214 0.414 0.410
SD
CV
1 0.004
6.3
0.005
8.7
2 0.023
11.3
0.016
7.2
3 0.035
8.4
0.055
13.4
# Points 46 166 17 114 7 9
# Labs 6 6 5 5 4 4
Calcitonin Electrochemiluminescence (ECL) pg/mL

Mean 59.65 60.79 206.5 214.5 418.4 412.7
SD
CV
1 5.27
8.8
5.53
9.1
2 23.39
11.3
15.52
7.2
3 35.32
8.4
57.92
14.0
# Points 18 117 17 114 6 8
# Labs 5 5 5 5 3 3

Mean 62.22 60.60 −− −− 385.0 385.0
SD
CV
1 2.08
3.3
4.61
7.6
2 −−
−−
−−
−−
3 0.000
0.0
0.000
0.0
# Points 28 49 −− −− 1 1
# Labs 1 1 1 1

Mean 61.21 60.73 206.5 214.5 413.6 409.6
SD
CV
1 3.83
6.3
5.26
8.7
2 23.39
11.3
15.52
7.2
3 34.62
8.4
54.96
13.4
# Points 46 166 17 114 7 9
# Labs 6 6 5 5 4 4
Carbamazepine (Tegretol) Chemiluminescence µg/mL

Mean 2.88 2.72 7.89 7.31 13.11 12.89
SD
CV
1 0.189
6.6
0.807
29.7
2 0.419
5.3
2.17
29.6
3 0.368
2.8
0.495
3.8
# Points 17 65 16 65 8 39
# Labs 4 5 3 4 2 3

Mean −− 2.85 −− 7.94 −− 12.91
SD
CV
1 −−
−−
0.317
11.2
2 −−
−−
0.772
9.7
3 −−
−−
1.42
11.0
# Points −− 69 −− 66 −− 44
# Labs 2 2 1

Mean 2.49 2.53 6.84 6.92 11.25 11.35
SD
CV
1 0.171
6.8
0.155
6.1
2 0.275
4.0
0.330
4.8
3 0.616
5.5
0.578
5.1
# Points 30 85 19 63 35 90
# Labs 3 3 3 3 4 4
Mean −− 2.41 −− 6.52 −− 10.60
SD
CV
1 −−
−−
0.339
14.1
2 −−
−−
0.405
6.2
3 −−
−−
0.997
9.4
# Points −− 7 −− 6 −− 7
# Labs 1 1 1

Mean 2.63 2.68 7.32 7.37 11.60 12.04
SD
CV
1 0.258
9.8
0.497
18.6
2 0.632
8.6
1.39
18.9
3 0.930
8.0
1.18
9.8
# Points 47 226 35 200 43 180
# Labs 7 11 6 10 6 9

Carbamazepine (Tegretol) EIA µg/mL

Beckman Coulter AU Series
Mean 2.73 2.69 7.39 7.58 11.89 12.10
SD
CV
1 0.284
10.4
0.279
10.4
2 0.530
7.2
0.670
8.8
3 0.935
7.9
1.03
8.5
# Points 116 333 71 165 117 331
# Labs 4 4 2 2 4 4
Beckman Coulter AU Series • Emit 2000 Carbamazepine, REF OSR4F229

Mean 2.63 2.63 −− −− 12.91 12.91
SD
CV
1 0.450
17.1
0.450
17.1
−−
−−
2 −−
−−
3 1.00
7.7
1.00
7.7
# Points 28 28 −− −− 30 30
# Labs 1 1 1 1
Beckman Coulter AU Series • Thermo Scientific (Microgenics) CEDIA

Mean 2.92 2.92 8.04 8.06 12.79 12.74
SD
CV
1 0.330
11.3
0.286
9.8
2
0.449
5.6
0.452
5.6
3 0.541
4.2
0.527
4.1
# Points 30 63 30 63 30 63
# Labs 1 2 1 2 1 2

Mean 2.70 2.38 8.30 8.56 13.40 14.59
SD
CV
1 0.100
3.7
0.284
11.9
2 0.000
0.0
0.383
4.5
3 0.200
1.5
1.27
8.7
# Points 5 30 2 46 3 39
# Labs 1 1 1 1 1 1

Mean −− 3.00 −− 6.89 −− 10.77
SD
CV
1 −−
−−
0.000
0.0
2 −−
−−
0.295
4.3
3 −−
−−
0.388
3.6
# Points −− 40 −− 38 −− 41
# Labs 1 1 2

Mean 3.00 3.54 6.84 7.01 10.97 11.20
SD
CV
1 0.000
0.0
1.39
39.3
2 0.392
5.7
0.387
5.5
3 0.584
5.3
0.536
4.8
# Points 35 104 32 90 34 120
# Labs 2 3 2 3 2 4

Mean 2.79 2.87 7.41 7.57 12.03 12.10
SD
CV
1 0.315
11.3
0.716
25.0
2 0.636
8.6
0.734
9.7
3 1.06
8.8
1.24
10.2
# Points 214 598 135 402 214 624
# Labs 9 12 6 9 9 14
Carbamazepine (Tegretol) Immunoturbidimetric µg/mL

Mean 2.70 2.70 7.55 7.55 11.37 11.37
SD
CV
1 0.210
7.8
0.210
7.8
2 0.226
3.0
0.226
3.0
3 0.234
2.1
0.234
2.1
# Points 6 6 6 6 6 6
# Labs 2 2 2 2 2 2
Hitachi Chemistry Series • Sekisui Nanopia

Mean 2.61 2.61 7.58 7.58 11.70 11.70
SD
CV
1 0.163
6.3
0.163
6.3
2 0.181
2.4
0.181
2.4
3 0.333
2.8
0.333
2.8
# Points 21 21 21 21 21 21
# Labs 1 1 1 1 1 1
Siemens Atellica CH Analyzer

Mean 2.77 2.78 7.70 7.69 12.52 12.45
SD
CV
1 0.116
4.2
0.098
3.5
2 0.167
2.2
0.143
1.9
3 0.208
1.7
0.226
1.8
# Points 31 262 30 227 28 216
# Labs 1 1 1 1 1 1

Carbamazepine (Tegretol) Immunoturbidimetric µg/mL

Siemens Atellica CH Analyzer • Siemens Atellica CH Carb, REF 11097515
Mean 2.86 2.83 7.72 7.68 12.34 12.30
SD
CV
1 0.079
2.8
0.141
5.0
2
0.137
1.8
0.186
2.4
3 0.297
2.4
0.323
2.6
# Points 37 180 37 193 37 187
# Labs 1 1 1 1 1 1

Mean 2.77 2.79 7.67 7.68 12.19 12.34
SD
CV
1 0.156
5.6
0.130
4.6
2 0.173
2.3
0.168
2.2
3 0.466
3.8
0.342
2.8
# Points 95 469 94 447 92 430
# Labs 5 5 5 5 5 5
Carbamazepine (Tegretol) KIMS (Roche) µg/mL

Mean 2.94 2.81 8.17 8.22 13.64 13.47
SD
CV
1 0.181
6.2
0.157
5.6
2 0.257
3.1
0.364
4.4
3 0.405
3.0
0.376
2.8
# Points 162 1356 162 1358 162 1353
# Labs 4 5 4 5 4 5

Mean 2.90 2.85 −− 8.36 13.83 13.53
SD
CV
1 0.063
2.2
0.095
3.3
2 −−
−−
0.192
2.3
3 0.258
1.9
0.434
3.2
# Points 32 98 −− 42 32 97
# Labs 1 2 1 1 2

Mean 2.93 2.81 8.17 8.23 13.67 13.47
SD
CV
1 0.168
5.7
0.154
5.5
2 0.257
3.1
0.360
4.4
3 0.391
2.9
0.381
2.8
# Points 194 1454 162 1400 194 1450
# Labs 5 7 4 6 5 7
Carbamazepine, Free Chemiluminescence µg/mL

Mean 2.51 2.38 6.95 6.84 11.04 10.67
SD
CV
1 0.118
4.7
0.208
8.7
2 0.260
3.7
0.403
5.9
3 0.573
5.2
1.27
11.9
# Points 9 16 9 16 9 17
# Labs 1 1 1 1 1 1

Mean 2.51 2.38 6.95 6.84 11.04 10.67
SD
CV
1 0.118
4.7
0.208
8.7
2 0.260
3.7
0.403
5.9
3 0.573
5.2
1.27
11.9
# Points 9 16 9 16 9 17
# Labs 1 1 1 1 1 1
CEA (Carcinoembryonic Antigen) Chemiluminescence ng/mL

Mean 2.19 2.22 18.24 18.39 38.41 38.74
SD
CV
1 0.156
7.1
0.172
7.8
2 0.778
4.3
0.912
5.0
3 1.46
3.8
1.58
4.1
# Points 464 1553 464 1631 395 1405
# Labs 27 34 26 34 26 34
Abbott ARCHITECT/Alinity (c, i, ci models) • Abbott Alinity

Mean 2.05 2.10 18.26 18.61 39.04 39.35
SD
CV
1 0.300
14.6
0.249
11.9
2
1.13
6.2
1.17
6.3
3 2.26
5.8
2.25
5.7
# Points 10 17 11 17 10 16
# Labs 1 1 1 1 1 1


Mean 1.17 1.19 18.65 18.79 37.20 37.48
SD
CV
1 0.037
3.1
0.059
5.0
2 0.193
1.0
0.437
2.3
3 0.517
1.4
0.596
1.6
# Points 8 26 10 26 13 32
# Labs 1 1 1 1 1 1

Mean 1.19 1.18 17.55 17.46 36.25 36.79
SD
CV
1 0.111
9.3
0.097
8.3
2 0.821
4.7
0.793
4.5
3 1.96
5.4
1.96
5.3
# Points 98 228 97 234 102 230
# Labs 6 7 5 6 8 8

Mean 1.13 1.10 16.33 16.30 34.23 34.42
SD
CV
1 0.107
9.5
0.112
10.2
2 0.984
6.0
0.938
5.8
3 2.03
5.9
2.10
6.1
# Points 268 797 275 782 299 952
# Labs 16 17 17 18 18 19
DiaSorin LIAISON/XL
Mean −− −− −− −− 37.24 37.24
SD
CV
1 −−
−−
−−
−−
2 −−
−−
−−
−−
3 1.49
4.0
1.49
4.0
# Points −− −− −− −− 4 4
# Labs 1 1
Mindray CL Series
Mean 1.44 1.44 18.43 18.43 38.42 38.42
SD
CV
1 0.202
14.0
0.202
14.0
2 0.330
1.8
0.330
1.8
3 0.000
0.0
0.000
0.0
# Points 8 8 6 6 1 1
# Labs 1 1 1 1 1 1

Mean 1.10 1.16 16.19 16.44 35.44 35.36
SD
CV
1 0.206
18.7
0.183
15.7
2 1.22
7.5
1.50
9.1
3 2.57
7.3
3.27
9.2
# Points 26 79 88 221 89 224
# Labs 1 3 4 4 4 4

Mean 1.12 1.06 16.24 16.10 35.51 35.41
SD
CV
1 0.160
14.3
0.186
17.5
2 1.13
7.0
1.08
6.7
3 2.07
5.8
2.14
6.0
# Points 107 392 163 547 146 393
# Labs 7 11 10 16 8 10

Mean 1.04 1.06 16.32 16.46 35.76 35.94
SD
CV
1 0.133
12.8
0.130
12.3
2 0.692
4.2
0.805
4.9
3 1.58
4.4
1.61
4.5
# Points 303 1336 333 1600 336 1583
# Labs 13 13 14 14 14 14

Mean 1.44 1.43 22.34 22.18 47.65 47.06
SD
CV
1 0.150
10.4
0.134
9.4
2 1.39
6.2
1.27
5.7
3 2.64
5.5
2.59
5.5
# Points 13 21 13 21 13 21
# Labs 1 1 1 1 1 1

Mean 2.13 1.99 −− 17.50 30.75 29.57
SD
CV
1 0.137
6.5
0.228
11.5
2 −−
−−
1.89
10.8
3 3.46
11.3
2.58
8.7
# Points 3 6 −− 4 2 4
# Labs 1 1 1 1 1


Mean 1.32 1.31 16.17 16.15 35.36 35.54
SD
CV
1 0.068
5.1
0.074
5.6
2 0.591
3.7
0.736
4.6
3 1.55
4.4
1.65
4.6
# Points 326 1293 295 1208 321 1326
# Labs 22 24 21 22 22 23

Mean 1.47 1.45 16.93 16.92 36.14 36.29
SD
CV
1 0.491
33.5
0.502
34.7
2 1.32
7.8
1.33
7.9
3 2.50
6.9
2.44
6.7
# Points 1634 5756 1755 6297 1731 6191
# Labs 97 114 101 119 106 118
CEA (Carcinoembryonic Antigen) EIA ng/mL

Tosoh AIA Models
Mean 1.77 1.79 18.75 18.80 38.43 38.80
SD
CV
1 0.057
3.2
0.069
3.8
2 0.655
3.5
0.555
2.9
3 1.18
3.1
1.31
3.4
# Points 22 46 22 56 22 61
# Labs 1 1 1 1 1 1

Mean 1.77 1.79 18.75 18.80 38.43 38.80
SD
CV
1 0.057
3.2
0.069
3.8
2 0.655
3.5
0.555
2.9
3 1.18
3.1
1.31
3.4
# Points 22 46 22 56 22 61
# Labs 1 1 1 1 1 1
CEA (Carcinoembryonic Antigen) Electrochemiluminescence (ECL) ng/mL

Mean 1.44 1.46 14.69 14.73 30.10 30.33
SD
CV
1 0.100
7.0
0.112
7.6
2 0.511
3.5
0.513
3.5
3 1.11
3.7
1.05
3.5
# Points 256 1407 258 1396 225 1111
# Labs 15 20 15 19 14 17

Mean 1.45 1.42 15.29 15.04 31.27 31.09
SD
CV
1 0.079
5.5
0.100
7.1
2 0.626
4.1
0.747
5.0
3 0.902
2.9
1.18
3.8
# Points 275 898 101 376 255 770
# Labs 14 17 9 12 13 16

Mean 1.51 1.56 15.02 15.22 30.50 30.71
SD
CV
1 0.217
14.4
0.194
12.4
2 1.27
8.4
0.974
6.4
3 2.14
7.0
1.96
6.4
# Points 94 478 95 459 156 528
# Labs 8 15 8 10 9 11

Mean 1.46 1.47 14.89 14.89 30.67 30.66
SD
CV
1 0.120
8.3
0.135
9.2
2 0.794
5.3
0.704
4.7
3 1.46
4.8
1.38
4.5
# Points 625 2783 454 2231 636 2409
# Labs 37 52 32 41 36 44
CEA (Carcinoembryonic Antigen) FIA ng/mL

Mean 0.810 0.772 7.95 8.17 13.56 13.70
SD
CV
1 0.020
2.5
0.044
5.8
2 0.600
7.5
0.422
5.2
3 0.487
3.6
0.570
4.2
# Points 2 6 2 14 12 17
# Labs 1 1 1 2 2 2

CEA (Carcinoembryonic Antigen) FIA ng/mL

Mean 0.810 0.772 7.95 8.17 13.56 13.70
SD
CV
1 0.020
2.5
0.044
5.8
2 0.600
7.5
0.422
5.2
3 0.487
3.6
0.570
4.2
# Points 2 6 2 14 12 17
# Labs 1 1 1 2 2 2
Cortisol Chemiluminescence ng/mL

Mean 33.16 33.39 150.5 151.9 236.1 238.9
SD
CV
1 2.21
6.7
2.27
6.8
2 6.48
4.3
6.96
4.6
3 10.34
4.4
11.49
4.8
# Points 1331 3945 1337 3946 1236 3636
# Labs 55 66 55 65 52 60
Abbott ARCHITECT/Alinity (c, i, ci models) • Abbott Alinity i Cortisol, REF 08P33

Mean 34.33 33.94 161.7 161.0 −− −−
SD
CV
1 2.89
8.4
2.13
6.3
2 3.51
2.2
2.74
1.7
3 −−
−−
−−
−−
# Points 3 5 3 5 −− −−
# Labs 1 1 1 1
Abbott ARCHITECT/Alinity (c, i, ci models) • Alternate Formulation/Standardization

Mean 34.00 33.40 154.9 153.4 241.7 240.9
SD
CV
1 1.61
4.7
1.67
5.0
23.95
2.6
4.35
2.8
3 8.95
3.7
7.66
3.2
# Points 38 215 38 191 38 242
# Labs 1 1 1 1 1 1

Mean 30.61 31.14 167.1 169.2 275.2 277.7
SD
CV
1 4.07
13.3
3.64
11.7
2 12.48
7.5
11.82
7.0
3 19.47
7.1
18.96
6.8
# Points 142 403 138 418 140 366
# Labs 10 10 9 10 10 10

Mean 28.15 27.79 159.0 160.1 262.0 263.7
SD
CV
1 2.91
10.4
3.08
11.1
2 11.83
7.4
13.09
8.2
3 18.73
7.2
19.07
7.2
# Points 489 1466 591 1660 530 1523
# Labs 30 33 32 34 32 34
Mean 28.50 29.81 153.1 163.0 253.5 267.4
SD
CV
1 1.27
4.5
3.09
10.4
2
2.47
1.6
8.81
5.4
3 4.87
1.9
16.67
6.2
# Points 3 19 3 17 3 16
# Labs 1 1 1 1 1 1
Mindray CL Series
Mean 31.54 31.67 172.5 173.5 274.5 278.5
SD
CV
1 1.55
4.9
1.48
4.7
2 10.23
5.9
9.70
5.6
3 16.81
6.1
16.18
5.8
# Points 75 110 75 114 46 74
# Labs 4 4 4 4 4 4

Mean −− −− 161.6 160.8 −− −−
SD
CV
1 −−
−−
−−
−−
2 3.30
2.0
3.39
2.1
3 −−
−−
−−
−−
# Points −− −− 25 73 −− −−
# Labs 1 1

Mean 25.60 30.91 144.8 177.4 −− 291.8
SD
CV
1 0.000
0.0
3.21
10.4
2 0.000
0.0
19.15
10.8
3 −−
−−
20.40
7.0
# Points 1 7 1 8 −− 3
# Labs 1 1 1 1 1

Cortisol Chemiluminescence ng/mL

Mean 30.90 31.41 183.1 185.6 301.3 300.6
SD
CV
1 2.96
9.6
3.11
9.9
2 14.67
8.0
15.93
8.6
3 23.18
7.7
28.37
9.4
# Points 276 1679 231 1151 202 1231
# Labs 13 19 12 16 12 16
Siemens ADVIA Centaur Systems • Siemens Centaur (COR), Cal Lot CE 39 & below
Mean 32.70 31.24 196.1 185.3 326.3 309.2
SD
CV
1 2.70
8.3
3.35
10.7
16.50
8.4
2
16.02
8.6
3 21.30
6.5
23.14
7.5
# Points 27 128 27 107 27 102
# Labs 1 1 1 1 1 1

Mean 35.19 35.36 213.0 213.7 340.6 343.5
SD
CV
1 4.29
12.2
3.98
11.3
2 22.14
10.4
20.58
9.6
3 31.80
9.3
30.13
8.8
# Points 381 1355 377 1343 356 1315
# Labs 12 12 11 11 10 10

Mean 30.24 29.66 162.3 159.1 227.5 227.1
SD
CV
1 4.07
13.5
3.76
12.7
2 16.45
10.1
17.25
10.8
3 16.76
7.4
20.45
9.0
# Points 172 393 170 391 60 189
# Labs 8 8 8 8 5 5
Snibe MAGLUMI
Mean −− −− 198.8 201.1 330.5 330.0
SD
CV
1 −−
−−
−−
−−
2 5.70
2.9
6.46
3.2
3 12.60
3.8
14.57
4.4
# Points −− −− 31 164 31 194
# Labs 1 1 1 1

Mean 40.88 39.56 202.0 204.1 371.2 376.2
SD
CV
1 2.57
6.3
2.81
7.1
2 8.07
4.0
9.54
4.7
3 12.26
3.3
15.57
4.1
# Points 6 12 11 24 5 12
# Labs 1 2 1 2 1 1

Mean 29.21 29.05 163.8 162.5 269.0 268.5
SD
CV
1 1.66
5.7
1.70
5.8
2 8.32
5.1
8.71
5.4
3 13.20
4.9
14.30
5.3
# Points 434 2076 414 1967 392 1941
# Labs 27 32 25 30 26 30

Mean 31.67 31.60 165.4 168.0 265.8 272.0
SD
CV
1 3.65
11.5
3.71
11.7
2 22.99
13.9
23.59
14.0
3 39.33
14.8
40.17
14.8
# Points 3340 11598 3434 11388 3028 10602
# Labs 164 190 163 186 155 174
Cortisol Chemiluminescence µg/dL

Mean 3.32 3.34 15.05 15.19 23.61 23.89
SD
CV
1 0.221
6.7
0.227
6.8
2 0.648
4.3
0.696
4.6
3 1.03
4.4
1.15
4.8
# Points 1331 3945 1337 3946 1236 3636
# Labs 55 66 55 65 52 60
Abbott ARCHITECT/Alinity (c, i, ci models) • Abbott Alinity i Cortisol, REF 08P33

Mean 3.43 3.39 16.17 16.10 −− −−
SD
CV
1 0.289
8.4
0.213
6.3
2
0.351
2.2
0.274
1.7
3 −−
−−
−−
−−
# Points 3 5 3 5 −− −−
# Labs 1 1 1 1


Mean 3.40 3.34 15.49 15.34 24.17 24.09
SD
CV
1 0.161
4.7
0.167
5.0
2
0.395
2.6
0.435
2.8
3 0.895
3.7
0.766
3.2
# Points 38 215 38 191 38 242
# Labs 1 1 1 1 1 1

Mean 3.06 3.11 16.71 16.92 27.52 27.77
SD
CV
1 0.407
13.3
0.364
11.7
2 1.25
7.5
1.18
7.0
3 1.95
7.1
1.90
6.8
# Points 142 403 138 418 140 366
# Labs 10 10 9 10 10 10

Mean 2.82 2.78 15.90 16.01 26.20 26.37
SD
CV
1 0.291
10.4
0.308
11.1
2 1.18
7.4
1.31
8.2
3 1.87
7.2
1.91
7.2
# Points 489 1466 591 1660 530 1523
# Labs 30 33 32 34 32 34
Mean 2.85 2.98 15.31 16.30 25.35 26.74
SD
CV
1 0.127
4.5
0.309
10.4
2
0.247
1.6
0.881
5.4
3 0.487
1.9
1.67
6.2
# Points 3 19 3 17 3 16
# Labs 1 1 1 1 1 1
Mindray CL Series
Mean 3.15 3.17 17.25 17.35 27.45 27.85
SD
CV
1 0.155
4.9
0.148
4.7
2 1.02
5.9
0.970
5.6
3 1.68
6.1
1.62
5.8
# Points 75 110 75 114 46 74
# Labs 4 4 4 4 4 4

Mean −− −− 16.16 16.08 −− −−
SD
CV
1 −−
−−
−−
−−
2 0.330
2.0
0.339
2.1
3 −−
−−
−−
−−
# Points −− −− 25 73 −− −−
# Labs 1 1

Mean 2.56 3.09 14.48 17.74 −− 29.18
SD
CV
1 0.000
0.0
0.321
10.4
2 0.000
0.0
1.92
10.8
3 −−
−−
2.04
7.0
# Points 1 7 1 8 −− 3
# Labs 1 1 1 1 1

Mean 3.09 3.14 18.31 18.56 30.13 30.06
SD
CV
1 0.296
9.6
0.311
9.9
2 1.47
8.0
1.59
8.6
3 2.32
7.7
2.84
9.4
# Points 276 1679 231 1151 202 1231
# Labs 13 19 12 16 12 16
Siemens ADVIA Centaur Systems • Siemens Centaur (COR), Cal Lot CE 39 & below
Mean 3.27 3.12 19.61 18.53 32.63 30.92
SD
CV
1 0.270
8.3
0.335
10.7
1.65
8.4
2 1.60
8.6
3 2.13
6.5
2.31
7.5
# Points 27 128 27 107 27 102
# Labs 1 1 1 1 1 1

Mean 3.52 3.54 21.30 21.37 34.06 34.35
SD
CV
1 0.429
12.2
0.398
11.3
2 2.21
10.4
2.06
9.6
3 3.18
9.3
3.01
8.8
# Points 381 1355 377 1343 356 1315
# Labs 12 12 11 11 10 10


Mean 3.02 2.97 16.23 15.91 22.75 22.71
SD
CV
1 0.407
13.5
0.376
12.7
2 1.64
10.1
1.72
10.8
3 1.68
7.4
2.04
9.0
# Points 172 393 170 391 60 189
# Labs 8 8 8 8 5 5
Snibe MAGLUMI
Mean −− −− 19.88 20.11 33.05 33.00
SD
CV
1 −−
−−
−−
−−
2 0.570
2.9
0.646
3.2
3 1.26
3.8
1.46
4.4
# Points −− −− 31 164 31 194
# Labs 1 1 1 1

Mean 4.09 3.96 20.20 20.41 37.12 37.62
SD
CV
1 0.257
6.3
0.281
7.1
2 0.807
4.0
0.954
4.7
3 1.23
3.3
1.56
4.1
# Points 6 12 11 24 5 12
# Labs 1 2 1 2 1 1

Mean 2.92 2.90 16.38 16.25 26.90 26.85
SD
CV
1 0.166
5.7
0.170
5.8
2 0.832
5.1
0.871
5.4
3 1.32
4.9
1.43
5.3
# Points 434 2076 414 1967 392 1941
# Labs 27 32 25 30 26 30

Mean 3.17 3.16 16.54 16.80 26.58 27.20
SD
CV
1 0.365
11.5
0.371
11.7
2 2.30
13.9
2.36
14.0
3 3.93
14.8
4.02
14.8
# Points 3340 11598 3434 11388 3028 10602
# Labs 164 190 163 186 155 174
Cortisol EIA ng/mL

Roche cobas c 303/503 • Roche Elecsys Cortisol II, REF 07027150
Mean 33.02 32.43 155.9 153.9 252.9 249.0
SD
CV
1 1.55
4.7
1.51
4.6
2
6.35
4.1
5.22
3.4
3 10.52
4.2
8.39
3.4
# Points 27 63 27 60 27 60
# Labs 1 1 1 1 1 1
Tosoh AIA Models

Mean 32.78 32.78 183.3 183.3 301.3 301.3
SD
CV
1 0.563
1.7
0.563
1.7
2 0.000
0.0
0.000
0.0
3 11.48
3.8
11.48
3.8
# Points 5 5 1 1 5 5
# Labs 1 1 1 1 1 1

Mean 32.98 32.46 156.9 154.4 260.4 253.0
SD
CV
1 1.44
4.4
1.46
4.5
2 8.10
5.2
6.40
4.1
3 20.71
8.0
16.44
6.5
# Points 32 68 28 61 32 65
# Labs 2 2 2 2 2 2
Cortisol EIA µg/dL

Roche cobas c 303/503 • Roche Elecsys Cortisol II, REF 07027150
Mean 3.30 3.24 15.59 15.39 25.29 24.90
SD
CV
1 0.155
4.7
0.151
4.6
2
0.635
4.1
0.522
3.4
3 1.05
4.2
0.839
3.4
# Points 27 63 27 60 27 60
# Labs 1 1 1 1 1 1

Cortisol EIA µg/dL

Tosoh AIA Models
Mean 3.28 3.28 18.33 18.33 30.13 30.13
SD
CV
1 0.056
1.7
0.056
1.7
2 0.000
0.0
0.000
0.0
3 1.15
3.8
1.15
3.8
# Points 5 5 1 1 5 5
# Labs 1 1 1 1 1 1

Mean 3.30 3.25 15.69 15.44 26.04 25.30
SD
CV
1 0.144
4.4
0.146
4.5
2 0.810
5.2
0.640
4.1
3 2.07
8.0
1.64
6.5
# Points 32 68 28 61 32 65
# Labs 2 2 2 2 2 2
Cortisol Electrochemiluminescence (ECL) ng/mL

Mean 34.75 34.30 162.7 161.6 269.8 265.2
SD
CV
1 2.07
6.0
1.94
5.7
2 8.51
5.2
7.75
4.8
3 17.91
6.6
16.38
6.2
# Points 144 517 161 683 113 523
# Labs 11 13 13 14 9 10
Roche cobas 6000/8000/c 311 • 2nd Generation

Mean 35.62 35.62 −− −− 283.1 283.1
SD
CV
1 0.956
2.7
0.956
2.7
2 −−
−−
−−
−−
3 8.52
3.0
8.52
3.0
# Points 21 21 −− −− 21 21
# Labs 1 1 1 1
Roche cobas 6000/8000/c 311 • Roche ECL Cortisol II (REF 06687733)

Mean 34.92 34.83 165.3 164.4 268.7 266.8
SD
CV
1 2.35
6.7
1.93
5.6
2
6.94
4.2
6.64
4.0
3 9.98
3.7
10.75
4.0
# Points 343 1524 374 1697 330 1638
# Labs 14 14 16 16 16 16

Mean 34.61 34.21 164.5 162.8 258.7 261.3
SD
CV
1 1.91
5.5
1.72
5.0
2 8.93
5.4
8.71
5.4
3 12.64
4.9
13.35
5.1
# Points 583 1888 443 1389 228 710
# Labs 19 20 14 15 11 12
Roche cobas e 402/801 • Roche ECL Cortisol II (REF 06687733)

Mean 33.95 33.80 161.3 159.8 264.0 261.9
SD
CV
1 0.436
1.3
0.730
2.2
2
3.18
2.0
4.26
2.7
3 7.41
2.8
8.10
3.1
# Points 31 64 31 65 31 65
# Labs 1 3 1 3 1 3
Roche cobas e 402/801 • Roche Elecsys Cortisol II, REF 07027150

Mean 33.51 33.47 157.2 158.0 261.9 261.0
SD
CV
1 1.38
4.1
1.40
4.2
2
6.09
3.9
6.69
4.2
3 7.79
3.0
11.12
4.3
# Points 138 329 110 301 75 207
# Labs 7 8 6 7 5 6
Roche cobas u 601

Mean 34.90 34.61 161.5 160.8 259.0 259.8
SD
CV
1 1.30
3.7
1.23
3.6
2 5.00
3.1
5.26
3.3
3 13.30
5.1
10.35
4.0
# Points 7 15 7 16 7 16
# Labs 1 1 1 1 1 1

Mean 35.19 34.50 162.5 161.2 263.7 265.7
SD
CV
1 2.31
6.6
2.15
6.2
2 9.06
5.6
9.27
5.7
3 17.02
6.5
17.50
6.6
# Points 145 534 142 536 109 398
# Labs 9 10 10 11 8 8

Cortisol Electrochemiluminescence (ECL) ng/mL

Roche Elecsys / cobas e 411 Series • Roche ECL Cortisol (REF 11875116)
Mean 31.05 31.05 150.2 150.2 240.2 240.2
SD
CV
1 1.20
3.9
1.20
3.9
2
4.38
2.9
4.38
2.9
3 4.17
1.7
4.17
1.7
# Points 2 2 2 2 2 2
# Labs 1 1 1 1 1 1
Roche Elecsys / cobas e 411 Series • Roche ECL Cortisol II (REF 06687733)
Mean 34.32 34.32 154.5 154.5 −− −−
SD
CV
1 0.975
2.8
0.975
2.8
2
4.61
3.0
4.61
3.0
3 −−
−−
−−
−−
# Points 19 19 19 19 −− −−
# Labs 1 1 1 1

Mean 34.64 34.40 163.4 162.6 265.3 265.0
SD
CV
1 2.05
5.9
1.87
5.4
2 8.34
5.1
7.96
4.9
3 13.65
5.1
13.35
5.0
# Points 1433 4913 1289 4708 916 3580
# Labs 65 72 63 69 53 58
Cortisol Electrochemiluminescence (ECL) µg/dL

Mean 3.48 3.43 16.27 16.16 26.98 26.52
SD
CV
1 0.207
6.0
0.194
5.7
2 0.851
5.2
0.775
4.8
3 1.79
6.6
1.64
6.2
# Points 144 517 161 683 113 523
# Labs 11 13 13 14 9 10
Roche cobas 6000/8000/c 311 • 2nd Generation

Mean 3.56 3.56 −− −− 28.31 28.31
SD
CV
1 0.096
2.7
0.096
2.7
2 −−
−−
−−
−−
3 0.852
3.0
0.852
3.0
# Points 21 21 −− −− 21 21
# Labs 1 1 1 1
Roche cobas 6000/8000/c 311 • Roche ECL Cortisol II (REF 06687733)

Mean 3.49 3.48 16.53 16.44 26.87 26.68
SD
CV
1 0.235
6.7
0.193
5.6
2
0.694
4.2
0.664
4.0
3 0.998
3.7
1.08
4.0
# Points 343 1524 374 1697 330 1638
# Labs 14 14 16 16 16 16

Mean 3.46 3.42 16.45 16.28 25.87 26.13
SD
CV
1 0.191
5.5
0.172
5.0
2 0.893
5.4
0.871
5.4
3 1.26
4.9
1.34
5.1
# Points 583 1888 443 1389 228 710
# Labs 19 20 14 15 11 12
Roche cobas e 402/801 • Roche ECL Cortisol II (REF 06687733)

Mean 3.40 3.38 16.13 15.98 26.40 26.19
SD
CV
1 0.044
1.3
0.073
2.2
2
0.318
2.0
0.426
2.7
3 0.741
2.8
0.810
3.1
# Points 31 64 31 65 31 65
# Labs 1 3 1 3 1 3
Roche cobas e 402/801 • Roche Elecsys Cortisol II, REF 07027150

Mean 3.35 3.35 15.72 15.80 26.19 26.10
SD
CV
1 0.138
4.1
0.140
4.2
2
0.609
3.9
0.669
4.2
3 0.779
3.0
1.11
4.3
# Points 138 329 110 301 75 207
# Labs 7 8 6 7 5 6
Roche cobas u 601

Mean 3.49 3.46 16.15 16.08 25.90 25.98
SD
CV
1 0.130
3.7
0.123
3.6
2 0.500
3.1
0.526
3.3
3 1.33
5.1
1.04
4.0
# Points 7 15 7 16 7 16
# Labs 1 1 1 1 1 1

Cortisol Electrochemiluminescence (ECL) µg/dL

Mean 3.52 3.45 16.25 16.12 26.37 26.57
SD
CV
1 0.231
6.6
0.215
6.2
2 0.906
5.6
0.927
5.7
3 1.70
6.5
1.75
6.6
# Points 145 534 142 536 109 398
# Labs 9 10 10 11 8 8
Roche Elecsys / cobas e 411 Series • Roche ECL Cortisol (REF 11875116)
Mean 3.10 3.10 15.02 15.02 24.02 24.02
SD
CV
1 0.120
3.9
0.120
3.9
2
0.438
2.9
0.438
2.9
3 0.417
1.7
0.417
1.7
# Points 2 2 2 2 2 2
# Labs 1 1 1 1 1 1
Roche Elecsys / cobas e 411 Series • Roche ECL Cortisol II (REF 06687733)
Mean 3.43 3.43 15.45 15.45 −− −−
SD
CV
1 0.097
2.8
0.097
2.8
2
0.461
3.0
0.461
3.0
3 −−
−−
−−
−−
# Points 19 19 19 19 −− −−
# Labs 1 1 1 1

Mean 3.46 3.44 16.34 16.26 26.53 26.50
SD
CV
1 0.205
5.9
0.187
5.4
2 0.834
5.1
0.796
4.9
3 1.36
5.1
1.33
5.0
# Points 1433 4913 1289 4708 916 3580
# Labs 65 72 63 69 53 58
Cortisol FIA ng/mL

Mean 27.54 26.36 164.5 156.0 253.2 255.3
SD
CV
1 0.000
0.0
1.09
4.1
2 7.93
4.8
14.87
9.5
3 24.20
9.6
24.79
9.7
# Points 1 5 3 20 12 15
# Labs 1 1 1 2 1 2

Mean 27.54 26.36 164.5 156.0 253.2 255.3
SD
CV
1 0.000
0.0
1.09
4.1
2 7.93
4.8
14.87
9.5
3 24.20
9.6
24.79
9.7
# Points 1 5 3 20 12 15
# Labs 1 1 1 2 1 2
Cortisol FIA µg/dL

Mean 2.75 2.64 16.45 15.60 25.32 25.53
SD
CV
1 0.000
0.0
0.109
4.1
2 0.793
4.8
1.49
9.5
3 2.42
9.6
2.48
9.7
# Points 1 5 3 20 12 15
# Labs 1 1 1 2 1 2

Mean 2.75 2.64 16.45 15.60 25.32 25.53
SD
CV
1 0.000
0.0
0.109
4.1
2 0.793
4.8
1.49
9.5
3 2.42
9.6
2.48
9.7
# Points 1 5 3 20 12 15
# Labs 1 1 1 2 1 2
DHEA Chemiluminescence ng/mL

Mean 74300 75200 168733 169536 605070 610453
SD
CV
1 2244
3.0
1928
2.6
2 3551
2.1
3273
1.9
3 8664 11675
1.4 1.9
# Points 5 10 6 11 10 15
# Labs 1 1 1 1 1 1

DHEA Chemiluminescence ng/mL

Mean 15.50 16.80 35.13 40.09 133.5 153.4
SD
CV
1 27.08
174.7
27.13
161.5
2 58.31
166.0
61.71
153.9
3 214.8
160.9
222.7
145.1
# Points 25 41 23 38 22 35
# Labs 2 2 2 2 2 2

Mean 12396 14759 34938 38090 189176 183243
SD
CV
1 28170 30158
227.2 204.3
2 69562
199.1
71470
187.6
3 284920 282583
150.6 154.2
# Points 30 51 29 49 32 50
# Labs 3 3 3 3 3 3
DHEA−Sulfate Chemiluminescence ng/mL

Mean 760.4 760.8 1681 1680 6045 6050
SD
CV
1 36.35
4.8
39.47
5.2
2 66.99
4.0
74.30
4.4
3 230.3
3.8
261.2
4.3
# Points 1156 3586 1102 3429 990 3240
# Labs 30 34 28 33 27 29

Mean 631.7 631.5 1417 1384 4535 4477
SD
CV
1 37.90
6.0
30.95
4.9
2 82.60
5.8
93.56
6.8
3 267.0
5.9
247.3
5.5
# Points 3 4 3 4 3 4
# Labs 1 1 1 1 1 1

Mean 657.8 652.2 1424 1389 4614 4655
SD
CV
1 56.70
8.6
60.19
9.2
2 97.96
6.9
117.8
8.5
3 435.4
9.4
416.0
8.9
# Points 233 976 220 853 208 827
# Labs 13 13 12 12 10 11
DiaSorin LIAISON/XL
Mean 586.0 558.1 1406 1355 5114 4581
SD
CV
1 35.25
6.0
60.94
10.9
2 182.5
13.0
162.3
12.0
3 813.2
15.9
943.1
20.6
# Points 12 22 12 22 14 24
# Labs 1 1 1 1 1 1
Mindray CL Series
Mean 691.0 678.6 1669 1648 5634 5647
SD
CV
1 49.30
7.1
47.62
7.0
2 107.3
6.4
102.9
6.2
3 365.0
6.5
333.5
5.9
# Points 89 203 89 202 57 161
# Labs 4 5 4 5 3 4

Mean 690.1 679.1 1357 1369 4601 4647
SD
CV
1 36.51
5.3
48.01
7.1
2 96.17
7.1
79.58
5.8
3 257.7
5.6
224.3
4.8
# Points 12 64 14 64 14 66
# Labs 1 1 1 1 1 1

Mean 645.3 662.0 1339 1365 4636 4614
SD
CV
1 62.57
9.7
83.35
12.6
2 143.2
10.7
144.6
10.6
3 317.5
6.8
372.3
8.1
# Points 111 318 107 290 100 266
# Labs 4 4 4 4 4 4

Mean 671.5 687.3 1359 1390 4611 4654
SD
CV
1 30.05
4.5
40.86
5.9
2 47.35
3.5
69.16
5.0
3 138.8
3.0
203.6
4.4
# Points 48 238 48 238 48 238
# Labs 2 2 2 2 2 2

DHEA−Sulfate Chemiluminescence ng/mL

Mean 634.7 633.7 1322 1304 4641 4666
SD
CV
1 80.00
12.6
79.48
12.5
2 152.9
11.6
150.4
11.5
3 582.5
12.6
505.8
10.8
# Points 116 353 135 434 101 392
# Labs 8 9 9 10 8 9

Mean 37389 34361 114475 120682 205238 254444
SD
CV
1 34409
92.0
30969
90.1
2 92618 82264
80.9 68.2
3 274735 261381
133.9 102.7
# Points 7 16 10 22 5 12
# Labs 2 2 2 2 2 2

Mean 867.5 814.6 2234 2042 6230 6121
SD
CV
1 3038
350.2
2370
291.0
2 10830
484.8
9031
442.3
3 18050
289.7
16915
276.3
# Points 1787 5780 1740 5558 1540 5230
# Labs 66 72 64 71 59 64
DHEA−Sulfate Chemiluminescence µg/dL

Mean 76.04 76.08 168.1 168.0 604.5 605.0
SD
CV
1 3.64
4.8
3.95
5.2
2 6.70
4.0
7.43
4.4
3 23.03
3.8
26.12
4.3
# Points 1156 3586 1102 3429 990 3240
# Labs 30 34 28 33 27 29

Mean 63.17 63.15 141.7 138.4 453.5 447.7
SD
CV
1 3.79
6.0
3.09
4.9
2 8.26
5.8
9.36
6.8
3 26.70
5.9
24.73
5.5
# Points 3 4 3 4 3 4
# Labs 1 1 1 1 1 1

Mean 65.78 65.22 142.4 138.9 461.4 465.5
SD
CV
1 5.67
8.6
6.02
9.2
2 9.80
6.9
11.78
8.5
3 43.54
9.4
41.60
8.9
# Points 233 976 220 853 208 827
# Labs 13 13 12 12 10 11
DiaSorin LIAISON/XL
Mean 58.60 55.81 140.6 135.5 511.4 458.1
SD
CV
1 3.52
6.0
6.09
10.9
2 18.25
13.0
16.23
12.0
3 81.32
15.9
94.31
20.6
# Points 12 22 12 22 14 24
# Labs 1 1 1 1 1 1
Mindray CL Series
Mean 69.10 67.86 166.9 164.8 563.4 564.7
SD
CV
1 4.93
7.1
4.76
7.0
2 10.73
6.4
10.29
6.2
3 36.50
6.5
33.35
5.9
# Points 89 203 89 202 57 161
# Labs 4 5 4 5 3 4

Mean 69.01 67.91 135.7 136.9 460.1 464.7
SD
CV
1 3.65
5.3
4.80
7.1
2 9.62
7.1
7.96
5.8
3 25.77
5.6
22.43
4.8
# Points 12 64 14 64 14 66
# Labs 1 1 1 1 1 1

Mean 64.53 66.20 133.9 136.5 463.6 461.4
SD
CV
1 6.26
9.7
8.33
12.6
2 14.32
10.7
14.46
10.6
3 31.75
6.8
37.23
8.1
# Points 111 318 107 290 100 266
# Labs 4 4 4 4 4 4

DHEA−Sulfate Chemiluminescence µg/dL

Mean 67.15 68.73 135.9 139.0 461.1 465.4
SD
CV
1 3.00
4.5
4.09
5.9
2 4.73
3.5
6.92
5.0
3 13.88
3.0
20.36
4.4
# Points 48 238 48 238 48 238
# Labs 2 2 2 2 2 2

Mean 63.47 63.37 132.2 130.4 464.1 466.6
SD
CV
1 8.00
12.6
7.95
12.5
2 15.29
11.6
15.04
11.5
3 58.25
12.6
50.58
10.8
# Points 116 353 135 434 101 392
# Labs 8 9 9 10 8 9

Mean 3739 3436 11448 12068 20524 25444
SD
CV
1 3441
92.0
3097
90.1
2 9262
80.9
8226
68.2
3 27474
133.9
26138
102.7
# Points 7 16 10 22 5 12
# Labs 2 2 2 2 2 2

Mean 86.75 81.46 223.4 204.2 623.0 612.1
SD
CV
1 303.8
350.2
237.0
291.0
2 1083
484.8
903.1
442.3
3 1805
289.7
1691
276.3
# Points 1787 5780 1740 5558 1540 5230
# Labs 66 72 64 71 59 64
DHEA−Sulfate Chemiluminescence µg/mL

Mean 0.760 0.761 1.68 1.68 6.04 6.05
SD
CV
1 0.036
4.8
0.039
5.2
2 0.067
4.0
0.074
4.4
3 0.230
3.8
0.261
4.3
# Points 1156 3586 1102 3429 990 3240
# Labs 30 34 28 33 27 29

Mean 0.632 0.632 1.42 1.38 4.54 4.48
SD
CV
1 0.038
6.0
0.031
4.9
2 0.083
5.8
0.094
6.8
3 0.267
5.9
0.247
5.5
# Points 3 4 3 4 3 4
# Labs 1 1 1 1 1 1

Mean 0.658 0.652 1.42 1.39 4.61 4.66
SD
CV
1 0.057
8.6
0.060
9.2
2 0.098
6.9
0.118
8.5
3 0.435
9.4
0.416
8.9
# Points 233 976 220 853 208 827
# Labs 13 13 12 12 10 11
DiaSorin LIAISON/XL
Mean 0.586 0.558 1.41 1.36 5.11 4.58
SD
CV
1 0.035
6.0
0.061
10.9
2 0.182
13.0
0.162
12.0
3 0.813
15.9
0.943
20.6
# Points 12 22 12 22 14 24
# Labs 1 1 1 1 1 1
Mindray CL Series
Mean 0.691 0.679 1.67 1.65 5.63 5.65
SD
CV
1 0.049
7.1
0.048
7.0
2 0.107
6.4
0.103
6.2
3 0.365
6.5
0.333
5.9
# Points 89 203 89 202 57 161
# Labs 4 5 4 5 3 4

Mean 0.690 0.679 1.36 1.37 4.60 4.65
SD
CV
1 0.037
5.3
0.048
7.1
2 0.096
7.1
0.080
5.8
3 0.258
5.6
0.224
4.8
# Points 12 64 14 64 14 66
# Labs 1 1 1 1 1 1

DHEA−Sulfate Chemiluminescence µg/mL

Mean 0.645 0.662 1.34 1.37 4.64 4.61
SD
CV
1 0.063
9.7
0.083
12.6
2 0.143
10.7
0.145
10.6
3 0.318
6.8
0.372
8.1
# Points 111 318 107 290 100 266
# Labs 4 4 4 4 4 4

Mean 0.672 0.687 1.36 1.39 4.61 4.65
SD
CV
1 0.030
4.5
0.041
5.9
2 0.047
3.5
0.069
5.0
3 0.139
3.0
0.204
4.4
# Points 48 238 48 238 48 238
# Labs 2 2 2 2 2 2

Mean 0.635 0.634 1.32 1.30 4.64 4.67
SD
CV
1 0.080
12.6
0.079
12.5
2 0.153
11.6
0.150
11.5
3 0.583
12.6
0.506
10.8
# Points 116 353 135 434 101 392
# Labs 8 9 9 10 8 9

Mean 37.39 34.36 114.5 120.7 205.2 254.4
SD
CV
1 34.41
92.0
30.97
90.1
2 92.62
80.9
82.26
68.2
3 274.7
133.9
261.4
102.7
# Points 7 16 10 22 5 12
# Labs 2 2 2 2 2 2

Mean 0.868 0.815 2.23 2.04 6.23 6.12
SD
CV
1 3.04
350.2
2.37
291.0
2 10.83
484.8
9.03
442.3
3 18.05
289.7
16.91
276.3
# Points 1787 5780 1740 5558 1540 5230
# Labs 66 72 64 71 59 64
DHEA−Sulfate EIA ng/mL

Tosoh AIA Models
Mean 801.0 765.0 1734 1677 6045 5823
SD
CV
1 67.01
8.4
61.97
8.1
2 128.2
7.4
128.5
7.7
3 294.9
4.9
297.7
5.1
# Points 8 23 6 21 8 23
# Labs 2 3 2 3 2 3

Mean 801.0 765.0 1734 1677 6045 5823
SD
CV
1 67.01
8.4
61.97
8.1
2 128.2
7.4
128.5
7.7
3 294.9
4.9
297.7
5.1
# Points 8 23 6 21 8 23
# Labs 2 3 2 3 2 3
DHEA−Sulfate EIA µg/dL

Tosoh AIA Models
Mean 80.10 76.50 173.4 167.7 604.5 582.3
SD
CV
1 6.70
8.4
6.20
8.1
2 12.82
7.4
12.85
7.7
3 29.49
4.9
29.77
5.1
# Points 8 23 6 21 8 23
# Labs 2 3 2 3 2 3

Mean 80.10 76.50 173.4 167.7 604.5 582.3
SD
CV
1 6.70
8.4
6.20
8.1
2 12.82
7.4
12.85
7.7
3 29.49
4.9
29.77
5.1
# Points 8 23 6 21 8 23
# Labs 2 3 2 3 2 3

DHEA−Sulfate EIA µg/mL

Tosoh AIA Models
Mean 0.801 0.765 1.73 1.68 6.04 5.82
SD
CV
1 0.067
8.4
0.062
8.1
2 0.128
7.4
0.129
7.7
3 0.295
4.9
0.298
5.1
# Points 8 23 6 21 8 23
# Labs 2 3 2 3 2 3

Mean 0.801 0.765 1.73 1.68 6.04 5.82
SD
CV
1 0.067
8.4
0.062
8.1
2 0.128
7.4
0.129
7.7
3 0.295
4.9
0.298
5.1
# Points 8 23 6 21 8 23
# Labs 2 3 2 3 2 3
DHEA−Sulfate Electrochemiluminescence (ECL) ng/mL

Mean 829.5 845.4 1910 1934 6733 6859
SD
CV
1 45.39
5.5
77.97
9.2
2 132.8
7.0
144.8
7.5
3 484.8
7.2
605.3
8.8
# Points 173 450 209 613 180 555
# Labs 14 17 16 17 15 17

Mean 838.9 850.7 1927 1943 6952 6924
SD
CV
1 51.43
6.1
49.46
5.8
2 116.4
6.0
102.9
5.3
3 403.9
5.8
456.7
6.6
# Points 438 1276 377 1059 175 469
# Labs 13 14 12 13 9 9
Roche cobas e 402/801 • Roche Elecsys DHEA−S, REF 07027192

Mean 817.0 827.1 1882 1865 6707 6782
SD
CV
1 31.83
3.9
41.95
5.1
88.21
4.7
2 94.76
5.1
3 378.1
5.6
397.9
5.9
# Points 81 156 32 102 86 168
# Labs 3 3 2 2 3 3

Mean 833.9 842.2 1951 1917 6242 6549
SD
CV
1 65.85
7.9
79.61
9.5
2 87.42
4.5
137.5
7.2
3 281.2
4.5
453.5
6.9
# Points 22 90 9 32 10 68
# Labs 4 4 3 3 2 3

Mean 834.0 847.2 1919 1935 6802 6856
SD
CV
1 49.11
5.9
58.60
6.9
2 121.0
6.3
120.2
6.2
3 452.3
6.6
527.5
7.7
# Points 714 1972 627 1806 451 1260
# Labs 34 38 33 35 29 32
DHEA−Sulfate Electrochemiluminescence (ECL) µg/dL

Mean 82.95 84.54 191.0 193.4 673.3 685.9
SD
CV
1 4.54
5.5
7.80
9.2
2 13.28
7.0
14.48
7.5
3 48.48
7.2
60.53
8.8
# Points 173 450 209 613 180 555
# Labs 14 17 16 17 15 17

Mean 83.89 85.07 192.7 194.3 695.2 692.4
SD
CV
1 5.14
6.1
4.95
5.8
2 11.64
6.0
10.29
5.3
3 40.39
5.8
45.67
6.6
# Points 438 1276 377 1059 175 469
# Labs 13 14 12 13 9 9

DHEA−Sulfate Electrochemiluminescence (ECL) µg/dL

Mean 81.70 82.71 188.2 186.5 670.7 678.2
SD
CV
1 3.18
3.9
4.20
5.1
8.82
4.7
2 9.48
5.1
3 37.81
5.6
39.79
5.9
# Points 81 156 32 102 86 168
# Labs 3 3 2 2 3 3

Mean 83.39 84.22 195.1 191.7 624.2 654.9
SD
CV
1 6.59
7.9
7.96
9.5
2 8.74
4.5
13.75
7.2
3 28.12
4.5
45.35
6.9
# Points 22 90 9 32 10 68
# Labs 4 4 3 3 2 3

Mean 83.40 84.72 191.9 193.5 680.2 685.6
SD
CV
1 4.91
5.9
5.86
6.9
2 12.10
6.3
12.02
6.2
3 45.23
6.6
52.75
7.7
# Points 714 1972 627 1806 451 1260
# Labs 34 38 33 35 29 32
DHEA−Sulfate Electrochemiluminescence (ECL) µg/mL

Mean 0.830 0.845 1.91 1.93 6.73 6.86
SD
CV
1 0.045
5.5
0.078
9.2
2 0.133
7.0
0.145
7.5
3 0.485
7.2
0.605
8.8
# Points 173 450 209 613 180 555
# Labs 14 17 16 17 15 17

Mean 0.839 0.851 1.93 1.94 6.95 6.92
SD
CV
1 0.051
6.1
0.049
5.8
2 0.116
6.0
0.103
5.3
3 0.404
5.8
0.457
6.6
# Points 438 1276 377 1059 175 469
# Labs 13 14 12 13 9 9

Mean 0.817 0.827 1.88 1.87 6.71 6.78
SD
CV
1 0.032
3.9
0.042
5.1
0.088
4.7
2 0.095
5.1
3 0.378
5.6
0.398
5.9
# Points 81 156 32 102 86 168
# Labs 3 3 2 2 3 3

Mean 0.834 0.842 1.95 1.92 6.24 6.55
SD
CV
1 0.066
7.9
0.080
9.5
2 0.087
4.5
0.138
7.2
3 0.281
4.5
0.454
6.9
# Points 22 90 9 32 10 68
# Labs 4 4 3 3 2 3

Mean 0.834 0.847 1.92 1.94 6.80 6.86
SD
CV
1 0.049
5.9
0.059
6.9
2 0.121
6.3
0.120
6.2
3 0.452
6.6
0.528
7.7
# Points 714 1972 627 1806 451 1260
# Labs 34 38 33 35 29 32
Digoxin Chemiluminescence ng/mL

Mean 0.478 0.479 1.77 1.72 2.89 2.85
SD
CV
1 0.053
11.0
0.037
7.7
2 0.061
3.4
0.078
4.5
3 0.105
3.6
0.107
3.8
# Points 59 248 28 103 76 285
# Labs 6 6 4 4 4 4

Digoxin Chemiluminescence ng/mL

Mean −− 0.477 −− 1.72 −− 2.91
SD
CV
1 −−
−−
0.050
10.5
2
−−
−−
0.094
5.5
3 −−
−−
0.136
4.7
# Points −− 20 −− 17 −− 24
# Labs 1 1 1

Mean −− 0.784 −− 2.12 −− 3.21
SD
CV
1 −−
−−
0.054
6.9
2 −−
−−
0.100
4.7
3 −−
−−
0.142
4.4
# Points −− 72 −− 72 −− 71
# Labs 1 1 1

Mean 0.811 0.785 2.18 2.15 3.28 3.27
SD
CV
1 0.058
7.2
0.064
8.2
2 0.092
4.2
0.097
4.5
3 0.115
3.5
0.142
4.3
# Points 37 164 36 165 35 131
# Labs 3 3 3 3 2 2

Mean 0.847 0.852 2.49 2.46 3.90 3.82
SD
CV
1 0.075
8.8
0.060
7.0
2 0.120
4.8
0.113
4.6
3 0.080
2.1
0.211
5.5
# Points 15 70 28 149 13 136
# Labs 1 2 2 3 1 2

Mean 0.844 0.808 2.53 2.34 3.78 3.67
SD
CV
1 0.060
7.1
0.085
10.5
2 0.220
8.7
0.204
8.7
3 0.186
4.9
0.306
8.3
# Points 21 75 6 47 20 68
# Labs 2 2 1 1 2 2

Mean 0.671 0.674 2.17 2.17 3.20 3.24
SD
CV
1 0.184
27.5
0.169
25.1
2 0.308
14.2
0.282
13.0
3 0.398
12.4
0.419
13.0
# Points 132 629 98 536 144 691
# Labs 12 14 10 12 9 11
Digoxin EIA ng/mL

Mean 0.499 0.532 1.79 1.82 2.95 2.99
SD
CV
1 0.087
17.4
0.106
19.9
2 0.114
6.4
0.133
7.3
3 0.178
6.0
0.203
6.8
# Points 100 326 76 191 104 333
# Labs 3 3 2 2 3 3
Beckman Coulter AU Series • Emit 2000 Digoxin, REF OSR4H229

Mean 0.586 0.586 −− −− −− −−
SD
CV
1 0.050
8.5
0.050
8.5
−−
−−
2 −−
−−
3 −−
−−
−−
−−
# Points 25 25 −− −− −− −−
# Labs 1 1

Mean 0.776 0.802 −− −− 3.25 3.29
SD
CV
1 0.075
9.6
0.088
11.0
2 −−
−−
−−
−−
3 0.103
3.2
0.116
3.5
# Points 35 87 −− −− 35 84
# Labs 2 2 2 2

Mean −− 0.595 −− 1.75 −− 2.78
SD
CV
1 −−
−−
0.057
9.6
2 −−
−−
0.056
3.2
3 −−
−−
0.100
3.6
# Points −− 217 −− 121 −− 222
# Labs 6 3 6

Digoxin EIA ng/mL

Mean 0.610 0.568 1.71 1.71 −− 2.87
SD
CV
1 0.110
18.0
0.090
15.8
2 0.100
5.8
0.085
5.0
3 −−
−−
0.165
5.7
# Points 18 170 18 106 −− 188
# Labs 1 7 1 6 7

Mean 0.582 0.582 1.77 1.75 2.85 2.85
SD
CV
1 0.068
11.6
0.069
11.8
2 0.134
7.6
0.125
7.1
3 0.122
4.3
0.129
4.5
# Points 57 128 26 59 58 147
# Labs 5 7 4 4 5 7

Mean 0.777 0.777 −− −− 2.99 2.99
SD
CV
1 0.203
26.1
0.203
26.1
2 −−
−−
−−
−−
3 0.250
8.4
0.250
8.4
# Points 3 3 −− −− 4 4
# Labs 1 1 1 1

Mean 0.581 0.586 1.77 1.77 2.97 2.92
SD
CV
1 0.125
21.4
0.114
19.4
2 0.119
6.7
0.115
6.5
3 0.204
6.9
0.211
7.2
# Points 238 956 120 477 201 978
# Labs 13 27 7 15 11 26
Digoxin Electrochemiluminescence (ECL) ng/mL

Mean 0.677 0.676 2.07 2.07 3.46 3.44
SD
CV
1 0.031
4.6
0.043
6.4
2 0.070
3.4
0.067
3.2
3 0.101
2.9
0.149
4.3
# Points 42 219 40 222 39 217
# Labs 4 5 3 4 3 5

Mean 0.677 0.676 2.07 2.07 3.46 3.44
SD
CV
1 0.031
4.6
0.043
6.4
2 0.070
3.4
0.067
3.2
3 0.101
2.9
0.149
4.3
# Points 42 219 40 222 39 217
# Labs 4 5 3 4 3 5
Digoxin Immunoturbidimetric ng/mL

Mean 0.680 0.700 2.19 2.18 3.56 3.57
SD
CV
1 0.084
12.4
0.095
13.6
2 0.104
4.8
0.118
5.4
3 0.198
5.6
0.194
5.4
# Points 42 208 42 207 41 206
# Labs 3 3 3 3 3 3
Beckman Coulter AU Series • Thermo Scientific (Microgenics) DRI

Mean 0.748 0.730 2.24 2.20 3.51 3.44
SD
CV
1 0.032
4.3
0.069
9.5
2
0.051
2.3
0.082
3.7
3 0.055
1.6
0.131
3.8
# Points 30 64 30 64 30 63
# Labs 1 2 1 2 1 2

Mean 0.717 0.717 2.21 2.21 3.42 3.42
SD
CV
1 0.055
7.6
0.055
7.6
2 0.073
3.3
0.073
3.3
3 0.078
2.3
0.078
2.3
# Points 21 21 21 21 21 21
# Labs 1 1 1 1 1 1

Digoxin Immunoturbidimetric ng/mL

Mean 0.689 0.649 2.16 2.14 3.40 3.38
SD
CV
1 0.096
13.9
0.094
14.5
2 0.105
4.8
0.112
5.2
3 0.178
5.2
0.142
4.2
# Points 101 622 101 609 97 581
# Labs 4 4 4 4 4 4

Mean 0.699 0.668 2.18 2.16 3.45 3.43
SD
CV
1 0.085
12.2
0.096
14.4
2 0.099
4.5
0.112
5.2
3 0.173
5.0
0.173
5.0
# Points 194 915 194 901 189 871
# Labs 9 10 9 10 9 10
Digoxin KIMS (Roche) ng/mL

Mean 0.812 0.819 2.22 2.19 3.44 3.39
SD
CV
1 0.104
12.8
0.114
13.9
2 0.094
4.2
0.119
5.4
3 0.114
3.3
0.130
3.8
# Points 182 1461 182 1461 180 1463
# Labs 4 6 4 6 4 6

Mean 0.843 0.838 −− −− 3.48 3.47
SD
CV
1 0.077
9.2
0.067
8.0
2 −−
−−
−−
−−
3 0.092
2.6
0.121
3.5
# Points 31 56 −− −− 31 56
# Labs 1 1 1 1

Mean 0.817 0.820 2.22 2.19 3.44 3.39
SD
CV
1 0.101
12.3
0.112
13.7
2 0.094
4.2
0.119
5.4
3 0.112
3.3
0.130
3.8
# Points 213 1517 182 1461 211 1519
# Labs 5 7 4 6 5 7
Estradiol, E2 Chemiluminescence ng/mL

1drop
Mean 0.704 0.731 1.60 1.65 1.96 3.10
SD
CV
1 0.814
115.7
0.551
75.4
2 1.86
115.9
1.25
76.1
3 1.83
93.1
1.56
50.2
# Points 59 128 58 126 51 118
# Labs 3 3 3 3 2 2
Abbott Alinity i
Mean 0.082 0.082 0.158 0.158 0.322 0.322
SD
CV
1 0.007
8.7
0.007
9.0
2 0.008
5.3
0.008
5.2
3 0.013
3.9
0.013
4.0
# Points 1246 3849 1171 3758 1188 3670
# Labs 42 47 38 44 42 46
Abbott ARCHITECT (c, i, ci models)

Mean 0.081 0.080 0.164 0.162 0.335 0.333
SD
CV
1 0.005
6.4
0.006
6.9
2 0.007
4.0
0.008
5.2
3 0.011
3.2
0.011
3.4
# Points 449 1530 353 1036 334 1153
# Labs 22 27 18 21 18 19

Mean 0.085 0.088 0.157 0.163 −− −−
SD
CV
1 0.011
12.6
0.011
12.4
2 0.012
7.7
0.016
9.7
3 −−
−−
−−
−−
# Points 34 97 32 92 −− −−
# Labs 1 1 1 1


Mean 0.100 0.089 0.260 0.249 0.771 0.733
SD
CV
1 0.005
5.0
0.011
11.9
2 0.003
1.3
0.010
4.1
3 0.005
0.6
0.051
7.0
# Points 3 10 2 9 3 7
# Labs 1 1 1 1 1 1

Mean 0.372 0.496 0.843 1.11 1.89 2.27
SD
CV
1 0.357
96.0
0.362
73.1
2 0.791
93.8
0.793
71.6
3 1.77
93.8
1.78
78.1
# Points 45 83 43 81 43 89
# Labs 5 7 4 7 5 7
Beckman Coulter Access, LXi 725, DxC 600i IA Systems • Alternate Calibration
Mean 0.078 0.084 −− 0.201 0.514 0.437
SD
CV
1 0.001
1.2
0.010
11.6
2−−
−−
0.018
8.7
3 0.000
0.0
0.049
11.2
# Points 3 7 −− 4 1 8
# Labs 1 1 1 1 1
Beckman Coulter Access, LXi 725, DxC 600i IA Systems • BC Access Sensitive Estradiol, REF B84493
Mean 0.523 0.601 1.22 1.35 2.77 3.00
SD
CV
1 0.336
64.3
0.335
55.7
2
0.764
62.4
0.746
55.4
3 1.73
62.6
1.66
55.3
# Points 36 216 35 215 35 215
# Labs 4 4 4 4 4 4

Mean 0.079 0.079 0.166 0.167 0.370 0.371
SD
CV
1 0.005
6.9
0.005
6.3
2 0.008
5.0
0.009
5.1
3 0.022
6.0
0.020
5.5
# Points 222 1438 173 1042 216 1173
# Labs 15 21 11 19 15 19
Beckman Coulter UniCel DxI Series • BC Access Sensitive Estradiol, REF B84493
Mean 0.080 0.081 0.166 0.169 0.360 0.368
SD
CV
1 0.009
10.9
0.007
8.1
2
0.009
5.2
0.009
5.6
3 0.019
5.3
0.024
6.4
# Points 151 779 254 1023 284 1162
# Labs 15 20 17 22 19 24
Dirui CS Series
Mean −− 33.33 −− 64.81 −− −−
SD
CV
1 −−
−−
4.38
13.1
2 −−
−−
6.33
9.8
3 −−
−−
−−
−−
# Points −− 37 −− 37 −− −−
# Labs 1 2
Mindray CL Series
Mean 0.107 0.107 0.220 0.145 0.563 0.566
SD
CV
1 0.006
5.9
0.006
5.7
2 0.011
5.1
0.081
55.9
3 0.021
3.7
0.020
3.6
# Points 42 60 55 210 19 27
# Labs 2 2 3 4 2 2

Mean 0.077 0.080 0.231 0.232 0.682 0.679
SD
CV
1 0.006
8.2
0.006
8.0
2 0.020
8.6
0.019
8.1
3 0.040
5.9
0.039
5.7
# Points 40 254 47 272 43 265
# Labs 3 3 4 4 3 4

Mean 0.080 0.081 0.225 0.225 0.682 0.683
SD
CV
1 0.009
10.8
0.008
10.2
2 0.012
5.5
0.012
5.5
3 0.031
4.6
0.031
4.6
# Points 144 524 97 440 123 471
# Labs 8 12 7 12 7 11


Siemens ADVIA Chemistry Systems
Mean 0.082 0.084 0.223 0.224 0.656 0.661
SD
CV
1 0.008
9.8
0.013
15.6
2 0.011
4.9
0.011
4.7
3 0.112
17.0
0.077
11.7
# Points 31 67 31 66 31 67
# Labs 1 1 1 1 1 1

Mean 0.077 0.077 0.227 0.227 0.683 0.683
SD
CV
1 0.008
10.5
0.008
10.5
2 0.013
5.8
0.013
5.8
3 0.037
5.4
0.037
5.4
# Points 13 13 13 13 13 13
# Labs 1 1 1 1 1 1

Mean 0.084 0.083 0.231 0.231 0.717 0.716
SD
CV
1 0.007
8.9
0.007
8.6
2 0.013
5.6
0.015
6.6
3 0.031
4.3
0.033
4.6
# Points 252 1228 257 1219 271 1131
# Labs 10 12 10 11 11 11

Mean 0.086 0.084 0.244 0.244 0.614 0.607
SD
CV
1 0.012
14.1
0.013
15.1
2 0.025
10.3
0.025
10.4
3 0.052
8.5
0.050
8.2
# Points 43 124 43 122 43 123
# Labs 3 3 3 3 3 3

Mean 0.086 0.082 0.349 0.337 0.864 0.829
SD
CV
1 0.018
20.7
0.024
29.7
2 0.030
8.5
0.062
18.4
3 0.080
9.2
0.161
19.4
# Points 17 19 28 37 27 35
# Labs 1 3 2 3 2 3
Tosoh AIA Models

Mean 2.46 2.35 5.76 5.59 14.21 13.66
SD
CV
1 0.114
4.6
0.147
6.2
2 0.146
2.5
0.280
5.0
3 0.455
3.2
0.664
4.9
# Points 24 203 24 203 24 200
# Labs 1 1 1 1 1 1

Mean 0.085 0.082 0.315 0.306 0.912 0.903
SD
CV
1 0.010
11.6
0.009
10.9
2 0.026
8.2
0.025
8.1
3 0.058
6.4
0.053
5.9
# Points 502 2383 455 2198 453 2174
# Labs 27 32 25 30 24 29

Mean 0.119 0.229 0.286 0.529 0.659 0.813
SD
CV
1 0.252
212.2
1.81
789.9
2 0.600
209.8
3.64
687.6
3 1.30
196.7
1.77
217.5
# Points 3353 13042 3171 12199 3201 12093
# Labs 165 202 154 194 161 188
Estradiol, E2 Chemiluminescence pg/mL

1drop
Mean 703.5 731.3 1601 1648 1965 3096
SD
CV
1 813.8
115.7
551.2
75.4
2 1856
115.9
1255
76.1
3 1830
93.1
1555
50.2
# Points 59 128 58 126 51 118
# Labs 3 3 3 3 2 2
Abbott Alinity i
Mean 81.77 81.78 157.6 158.3 321.6 322.2
SD
CV
1 7.09
8.7
7.36
9.0
2 8.38
5.3
8.26
5.2
3 12.68
3.9
12.92
4.0
# Points 1246 3849 1171 3758 1188 3670
# Labs 42 47 38 44 42 46


Mean 80.56 79.61 164.3 162.1 335.4 333.3
SD
CV
1 5.19
6.4
5.51
6.9
2 6.53
4.0
8.48
5.2
3 10.75
3.2
11.46
3.4
# Points 449 1530 353 1036 334 1153
# Labs 22 27 18 21 18 19

Mean 84.53 88.00 157.0 162.9 −− −−
SD
CV
1 10.67
12.6
10.94
12.4
2 12.04
7.7
15.79
9.7
3 −−
−−
−−
−−
# Points 34 97 32 92 −− −−
# Labs 1 1 1 1

Mean 99.51 89.04 260.4 248.9 770.6 733.1
SD
CV
1 4.93
5.0
10.58
11.9
2 3.47
1.3
10.25
4.1
3 4.96
0.6
51.31
7.0
# Points 3 10 2 9 3 7
# Labs 1 1 1 1 1 1

Mean 371.5 495.6 843.0 1108 1887 2275
SD
CV
1 356.7
96.0
362.5
73.1
2 790.5
93.8
792.9
71.6
3 1769
93.8
1777
78.1
# Points 45 83 43 81 43 89
# Labs 5 7 4 7 5 7
Beckman Coulter Access, LXi 725, DxC 600i IA Systems • Alternate Calibration
Mean 77.65 84.02 −− 201.2 514.0 436.6
SD
CV
1 0.910
1.2
9.77
11.6
2−−
−−
17.54
8.7
3 0.000
0.0
48.72
11.2
# Points 3 7 −− 4 1 8
# Labs 1 1 1 1 1
Beckman Coulter Access, LXi 725, DxC 600i IA Systems • BC Access Sensitive Estradiol, REF B84493
Mean 522.6 600.7 1224 1347 2770 2996
SD
CV
1 335.8
64.3
334.6
55.7
2
764.1
62.4
745.7
55.4
3 1734
62.6
1657
55.3
# Points 36 216 35 215 35 215
# Labs 4 4 4 4 4 4

Mean 78.73 79.28 165.7 167.5 370.1 371.4
SD
CV
1 5.40
6.9
5.01
6.3
2 8.21
5.0
8.55
5.1
3 22.03
6.0
20.45
5.5
# Points 222 1438 173 1042 216 1173
# Labs 15 21 11 19 15 19
Beckman Coulter UniCel DxI Series • BC Access Sensitive Estradiol, REF B84493
Mean 79.77 80.88 166.2 169.2 360.0 367.7
SD
CV
1 8.67
10.9
6.53
8.1
2
8.65
5.2
9.42
5.6
3 18.94
5.3
23.57
6.4
# Points 151 779 254 1023 284 1162
# Labs 15 20 17 22 19 24
Dirui CS Series
Mean −− 33332 −− 64807 −− −−
SD
CV
1 −−
−−
4381
13.1
2 −−
−−
6333
9.8
3 −−
−−
−−
−−
# Points −− 37 −− 37 −− −−
# Labs 1 2
Mindray CL Series
Mean 107.1 107.3 219.6 144.9 562.9 565.8
SD
CV
1 6.34
5.9
6.12
5.7
2 11.17
5.1
81.03
55.9
3 20.65
3.7
20.32
3.6
# Points 42 60 55 210 19 27
# Labs 2 2 3 4 2 2


Mean 77.00 79.80 230.8 231.7 682.3 678.7
SD
CV
1 6.34
8.2
6.39
8.0
2 19.87
8.6
18.78
8.1
3 39.93
5.9
38.78
5.7
# Points 40 254 47 272 43 265
# Labs 3 3 4 4 3 4

Mean 80.30 81.05 224.6 225.3 682.1 682.7
SD
CV
1 8.70
10.8
8.25
10.2
2 12.41
5.5
12.48
5.5
3 31.34
4.6
31.08
4.6
# Points 144 524 97 440 123 471
# Labs 8 12 7 12 7 11

Mean 81.65 84.45 222.8 223.8 656.1 660.7
SD
CV
1 7.97
9.8
13.14
15.6
2 10.86
4.9
10.57
4.7
3 111.9
17.0
77.33
11.7
# Points 31 67 31 66 31 67
# Labs 1 1 1 1 1 1

Mean 77.12 77.12 226.7 226.7 682.6 682.6
SD
CV
1 8.07
10.5
8.07
10.5
2 13.24
5.8
13.24
5.8
3 37.04
5.4
37.04
5.4
# Points 13 13 13 13 13 13
# Labs 1 1 1 1 1 1

Mean 83.72 82.85 230.6 230.8 716.6 715.8
SD
CV
1 7.43
8.9
7.13
8.6
2 13.01
5.6
15.26
6.6
3 31.08
4.3
32.66
4.6
# Points 252 1228 257 1219 271 1131
# Labs 10 12 10 11 11 11

Mean 85.85 84.17 243.7 243.9 613.8 607.0
SD
CV
1 12.11
14.1
12.71
15.1
2 25.08
10.3
25.25
10.4
3 52.34
8.5
49.95
8.2
# Points 43 124 43 122 43 123
# Labs 3 3 3 3 3 3

Mean 86.43 81.83 349.4 337.3 864.4 829.1
SD
CV
1 17.90
20.7
24.34
29.7
2 29.57
8.5
62.08
18.4
3 79.59
9.2
161.2
19.4
# Points 17 19 28 37 27 35
# Labs 1 3 2 3 2 3
Tosoh AIA Models

Mean 2457 2352 5761 5591 14211 13664
SD
CV
1 113.9
4.6
146.5
6.2
2 146.5
2.5
279.7
5.0
3 454.5
3.2
664.1
4.9
# Points 24 203 24 203 24 200
# Labs 1 1 1 1 1 1

Mean 84.52 81.90 314.9 306.4 911.9 903.0
SD
CV
1 9.84
11.6
8.90
10.9
2 25.69
8.2
24.87
8.1
3 58.47
6.4
53.41
5.9
# Points 502 2383 455 2198 453 2174
# Labs 27 32 25 30 24 29

Mean 118.7 228.7 285.9 529.2 658.6 812.5
SD
CV
1 252.0
212.2
1807
789.9
2 599.9
209.8
3639
687.6
3 1295
196.7
1767
217.5
# Points 3353 13042 3171 12199 3201 12093
# Labs 165 202 154 194 161 188

Estradiol, E2 EIA ng/mL

Mean 0.104 0.104 0.315 0.315 0.932 0.932
SD
CV
1 0.008
7.2
0.008
7.2
2 0.007
2.2
0.007
2.2
3 0.058
6.2
0.058
6.2
# Points 6 6 6 6 6 6
# Labs 1 1 1 1 1 1
Roche cobas c 303/503 • Roche Elecsys Estradiol III REF 07027249

Mean 0.085 0.084 0.179 0.178 0.399 0.398
SD
CV
1 0.001
1.4
0.002
2.1
2
0.002
1.1
0.002
1.2
3 0.004
1.0
0.005
1.2
# Points 26 55 26 56 26 55
# Labs 1 1 1 1 1 1

Mean 0.085 0.084 0.182 0.179 0.402 0.408
SD
CV
1 0.005
5.8
0.004
4.9
2 0.007
3.7
0.007
3.8
3 0.020
4.9
0.013
3.3
# Points 28 58 28 70 7 33
# Labs 2 2 2 2 2 2
Tosoh AIA Models

Mean 0.245 0.234 0.572 0.572 1.37 1.38
SD
CV
1 0.012
4.9
0.026
11.2
2 0.026
4.5
0.026
4.5
3 0.100
7.3
0.081
5.8
# Points 10 133 2 2 10 133
# Labs 1 2 1 1 1 2
Tosoh AIA Models • Tosoh Estradiol, REF E2−025274

Mean −− 0.257 −− 0.619 −− 1.49
SD
CV
1 −−
−−
0.013
5.0
2 −−
−−
0.020
3.2
3 −−
−−
0.049
3.3
# Points −− 16 −− 16 −− 16
# Labs 1 1 1

Mean 0.109 0.169 0.206 0.236 0.662 1.02
SD
CV
1 0.056
51.7
0.078
46.2
2 0.078
38.0
0.143
60.4
3 0.403
60.8
0.479
46.8
# Points 70 268 62 150 49 243
# Labs 5 7 5 6 5 7
Estradiol, E2 EIA pg/mL

Mean 103.9 103.9 314.6 314.6 932.3 932.3
SD
CV
1 7.50
7.2
7.50
7.2
2 6.82
2.2
6.82
2.2
3 57.89
6.2
57.89
6.2
# Points 6 6 6 6 6 6
# Labs 1 1 1 1 1 1
Roche cobas c 303/503 • Roche Elecsys Estradiol III REF 07027249

Mean 84.51 83.97 179.3 178.1 399.2 398.3
SD
CV
1 1.17
1.4
1.80
2.1
21.91
1.1
2.19
1.2
3 4.06
1.0
4.65
1.2
# Points 26 55 26 56 26 55
# Labs 1 1 1 1 1 1

Mean 84.85 83.73 182.3 179.2 401.8 407.9
SD
CV
1 4.95
5.8
4.07
4.9
2 6.69
3.7
6.85
3.8
3 19.79
4.9
13.35
3.3
# Points 28 58 28 70 7 33
# Labs 2 2 2 2 2 2
Tosoh AIA Models

Mean 245.2 234.4 571.6 571.6 1367 1381
SD
CV
1 11.91
4.9
26.31
11.2
2 25.95
4.5
25.95
4.5
3 99.63
7.3
80.77
5.8
# Points 10 133 2 2 10 133
# Labs 1 2 1 1 1 2

Estradiol, E2 EIA pg/mL

Tosoh AIA Models • Tosoh Estradiol, REF E2−025274
Mean −− 256.5 −− 619.1 −− 1489
SD
CV
1 −−
−−
12.75
5.0
2 −−
−−
19.92
3.2
3 −−
−−
49.47
3.3
# Points −− 16 −− 16 −− 16
# Labs 1 1 1

Mean 109.3 169.3 206.4 236.4 662.3 1023
SD
CV
1 56.46
51.7
78.17
46.2
2 78.36
38.0
142.7
60.4
3 402.7
60.8
478.7
46.8
# Points 70 268 62 150 49 243
# Labs 5 7 5 6 5 7
Estradiol, E2 Electrochemiluminescence (ECL) ng/mL

1drop
Mean 0.080 0.080 0.176 0.176 0.402 0.402
SD
CV
1 0.002
2.0
0.002
2.0
2 0.005
2.6
0.005
2.6
3 0.005
1.3
0.005
1.3
# Points 28 28 29 29 29 29
# Labs 1 1 1 1 1 1
Lifotronic eCL Series

Mean −− 0.075 −− 0.188 −− 0.427
SD
CV
1 −−
−−
0.009
12.1
2 −−
−−
0.015
7.9
3 −−
−−
0.008
1.8
# Points −− 5 −− 5 −− 5
# Labs 1 1 1

Mean 0.084 0.084 0.178 0.177 0.401 0.396
SD
CV
1 0.006
7.6
0.006
6.6
2 0.007
4.0
0.007
3.8
3 0.017
4.3
0.017
4.3
# Points 411 1082 476 1291 359 1123
# Labs 25 28 24 27 23 25
Roche cobas 6000/8000/c 311 • 3rd Generation

Mean 0.090 0.090 −− −− 0.411 0.411
SD
CV
1 0.004
4.8
0.004
4.8
2 −−
−−
−−
−−
3 0.010
2.3
0.010
2.3
# Points 23 23 −− −− 23 23
# Labs 1 1 1 1
Roche cobas 6000/8000/c 311 • Roche Estradiol III 06656021190

Mean 0.086 0.084 0.180 0.178 0.400 0.398
SD
CV
1 0.004
4.8
0.004
5.0
0.005
2.5
2 0.006
3.1
3 0.012
3.0
0.012
2.9
# Points 281 1593 315 1813 288 1566
# Labs 10 11 13 14 12 12

Mean 0.088 0.087 0.185 0.183 0.394 0.394
SD
CV
1 0.007
8.1
0.006
7.2
2 0.009
4.8
0.008
4.6
3 0.012
3.0
0.011
2.8
# Points 766 2316 562 1794 377 1048
# Labs 26 28 20 22 18 20
Roche cobas e 402/801 • Roche Elecsys Estradiol III REF 07027249

Mean 0.083 0.082 0.176 0.175 0.395 0.393
SD
CV
1 0.004
4.6
0.005
6.4
0.006
3.3
20.006
3.2
3 0.010
2.5
0.010
2.6
# Points 207 719 145 604 151 596
# Labs 9 11 7 9 6 8
Mean 0.083 0.087 0.177 0.183 0.401 0.396
SD
CV
1 0.001
1.8
0.003
3.2
0.003
1.7
2 0.006
3.5
3 0.006
1.5
0.009
2.3
# Points 22 108 22 108 22 108
# Labs 1 1 1 1 1 1

Estradiol, E2 Electrochemiluminescence (ECL) ng/mL

Roche cobas e 402/801 • Roche Estradiol III 06656021190
Mean −− 0.082 0.177 0.176 0.395 0.393
SD
CV
1 −−
−−
0.002
2.0
2 0.003
1.4
0.003
1.6
3 0.004
1.1
0.007
1.7
# Points −− 9 9 23 9 22
# Labs 1 1 1 1 1
Roche cobas u 601

Mean 0.085 0.086 0.181 0.181 0.402 0.403
SD
CV
1 0.005
5.4
0.004
5.0
2 0.005
2.9
0.005
2.7
3 0.008
1.9
0.010
2.4
# Points 6 13 6 13 6 13
# Labs 1 1 1 1 1 1

Mean 0.081 0.080 0.177 0.176 0.408 0.409
SD
CV
1 0.007
8.9
0.010
12.7
2 0.010
5.9
0.025
14.3
3 0.020
4.9
0.049
12.1
# Points 434 1219 451 1304 379 1000
# Labs 27 32 29 32 26 30
Roche Elecsys / cobas e 411 Series • Roche ECL Estradiol II (03000079)

Mean 0.082 0.073 0.170 0.161 0.403 0.377
SD
CV
1 0.008
10.0
0.007
9.6
2
0.009
5.5
0.010
6.2
3 0.021
5.2
0.029
7.7
# Points 5 26 7 34 9 24
# Labs 1 1 1 1 1 1
Roche Elecsys / cobas e 411 Series • Roche Estradiol III 06656021190

Mean 0.079 0.080 0.175 0.174 0.404 0.400
SD
CV
1 0.006
7.1
0.006
7.1
20.007
4.2
0.006
3.6
3 0.011
2.7
0.010
2.5
# Points 190 755 171 656 146 655
# Labs 8 8 7 7 6 7

Mean 0.085 0.084 0.179 0.178 0.401 0.398
SD
CV
1 0.007
8.1
0.007
8.4
2 0.009
4.9
0.013
7.0
3 0.016
3.9
0.024
5.9
# Points 2373 7887 2193 7674 1798 6212
# Labs 110 124 105 117 97 109
Estradiol, E2 Electrochemiluminescence (ECL) pg/mL

1drop
Mean 79.95 79.95 175.7 175.7 401.6 401.6
SD
CV
1 1.62
2.0
1.62
2.0
2 4.61
2.6
4.61
2.6
3 5.09
1.3
5.09
1.3
# Points 28 28 29 29 29 29
# Labs 1 1 1 1 1 1

Mean −− 75.07 −− 187.7 −− 426.7
SD
CV
1 −−
−−
9.05
12.1
2 −−
−−
14.77
7.9
3 −−
−−
7.85
1.8
# Points −− 5 −− 5 −− 5
# Labs 1 1 1

Mean 84.14 83.86 177.8 176.8 400.5 396.2
SD
CV
1 6.41
7.6
5.53
6.6
2 7.03
4.0
6.79
3.8
3 17.31
4.3
17.14
4.3
# Points 411 1082 476 1291 359 1123
# Labs 25 28 24 27 23 25

Mean 90.34 90.34 −− −− 410.7 410.7
SD
CV
1 4.34
4.8
4.34
4.8
2 −−
−−
−−
−−
3 9.60
2.3
9.60
2.3
# Points 23 23 −− −− 23 23
# Labs 1 1 1 1

Estradiol, E2 Electrochemiluminescence (ECL) pg/mL

Roche cobas 6000/8000/c 311 • Roche Estradiol III 06656021190
Mean 85.85 84.32 179.8 178.4 400.4 397.6
SD
CV
1 4.09
4.8
4.23
5.0
2
4.55
2.5
5.58
3.1
3 12.05
3.0
11.54
2.9
# Points 281 1593 315 1813 288 1566
# Labs 10 11 13 14 12 12

Mean 87.51 87.05 185.0 182.8 393.7 393.6
SD
CV
1 7.05
8.1
6.25
7.2
2 8.86
4.8
8.43
4.6
3 11.72
3.0
11.00
2.8
# Points 766 2316 562 1794 377 1048
# Labs 26 28 20 22 18 20
Roche cobas e 402/801 • Roche Elecsys Estradiol III REF 07027249

Mean 83.45 82.22 175.6 175.4 394.9 393.3
SD
CV
1 3.80
4.6
5.25
6.4
2
5.78
3.3
5.67
3.2
3 9.92
2.5
10.33
2.6
# Points 207 719 145 604 151 596
# Labs 9 11 7 9 6 8
Mean 83.46 86.56 177.2 183.3 401.2 395.9
SD
CV
1 1.47
1.8
2.76
3.2
2
3.05
1.7
6.39
3.5
3 5.92
1.5
9.14
2.3
# Points 22 108 22 108 22 108
# Labs 1 1 1 1 1 1
Roche cobas e 402/801 • Roche Estradiol III 06656021190

Mean −− 82.23 177.0 176.1 394.8 392.8
SD
CV
1 −−
−−
1.62
2.0
2 2.50
1.4
2.85
1.6
3 4.44
1.1
6.66
1.7
# Points −− 9 9 23 9 22
# Labs 1 1 1 1 1
Roche cobas u 601

Mean 85.28 85.58 181.2 181.1 401.7 403.1
SD
CV
1 4.59
5.4
4.26
5.0
2 5.20
2.9
4.95
2.7
3 7.79
1.9
9.54
2.4
# Points 6 13 6 13 6 13
# Labs 1 1 1 1 1 1

Mean 81.46 80.26 176.7 175.7 408.0 409.1
SD
CV
1 7.26
8.9
10.20
12.7
2 10.44
5.9
25.22
14.3
3 20.11
4.9
49.41
12.1
# Points 434 1219 451 1304 379 1000
# Labs 27 32 29 32 26 30
Roche Elecsys / cobas e 411 Series • Roche ECL Estradiol II (03000079)

Mean 82.02 73.40 170.3 160.8 402.8 376.6
SD
CV
1 8.24
10.0
7.07
9.6
2
9.31
5.5
9.93
6.2
3 20.96
5.2
28.82
7.7
# Points 5 26 7 34 9 24
# Labs 1 1 1 1 1 1
Roche Elecsys / cobas e 411 Series • Roche Estradiol III 06656021190

Mean 79.49 79.54 174.8 173.8 403.6 400.1
SD
CV
1 5.62
7.1
5.62
7.1
27.33
4.2
6.25
3.6
3 11.02
2.7
9.81
2.5
# Points 190 755 171 656 146 655
# Labs 8 8 7 7 6 7

Mean 84.51 83.77 179.3 178.1 400.6 398.4
SD
CV
1 6.81
8.1
7.00
8.4
2 8.75
4.9
12.53
7.0
3 15.66
3.9
23.56
5.9
# Points 2373 7887 2193 7674 1798 6212
# Labs 110 124 105 117 97 109

Estradiol, E2 FIA ng/mL

Mean 0.106 0.104 0.319 0.322 0.896 0.901
SD
CV
1 0.006
6.1
0.006
6.1
2 0.012
3.8
0.016
4.8
3 0.038
4.3
0.040
4.4
# Points 27 180 30 181 29 179
# Labs 2 2 2 3 3 3

Mean 0.106 0.104 0.319 0.322 0.896 0.901
SD
CV
1 0.006
6.1
0.006
6.1
2 0.012
3.8
0.016
4.8
3 0.038
4.3
0.040
4.4
# Points 27 180 30 181 29 179
# Labs 2 2 2 3 3 3
Estradiol, E2 FIA pg/mL

Mean 106.1 104.1 318.9 322.1 895.8 901.1
SD
CV
1 6.46
6.1
6.39
6.1
2 12.13
3.8
15.57
4.8
3 38.42
4.3
39.84
4.4
# Points 27 180 30 181 29 179
# Labs 2 2 2 3 3 3

Mean 106.1 104.1 318.9 322.1 895.8 901.1
SD
CV
1 6.46
6.1
6.39
6.1
2 12.13
3.8
15.57
4.8
3 38.42
4.3
39.84
4.4
# Points 27 180 30 181 29 179
# Labs 2 2 2 3 3 3
Estradiol, E2 FPIA ng/mL

Mean 0.112 0.112 0.327 0.327 0.909 0.909
SD
CV
1 0.004
3.9
0.004
3.9
2 0.017
5.1
0.017
5.1
3 0.010
1.1
0.010
1.1
# Points 4 4 4 4 4 4
# Labs 1 1 1 1 1 1
Method Group • FPIA

Mean 0.112 0.112 0.327 0.327 0.909 0.909
SD
CV
1 0.004
3.9
0.004
3.9
2 0.017
5.1
0.017
5.1
3 0.010
1.1
0.010
1.1
# Points 4 4 4 4 4 4
# Labs 1 1 1 1 1 1
Estradiol, E2 FPIA pg/mL

Mean 112.1 112.1 326.6 326.6 909.5 909.5
SD
CV
1 4.34
3.9
4.34
3.9
2 16.69
5.1
16.69
5.1
3 10.19
1.1
10.19
1.1
# Points 4 4 4 4 4 4
# Labs 1 1 1 1 1 1

Mean 112.1 112.1 326.6 326.6 909.5 909.5
SD
CV
1 4.34
3.9
4.34
3.9
2 16.69
5.1
16.69
5.1
3 10.19
1.1
10.19
1.1
# Points 4 4 4 4 4 4
# Labs 1 1 1 1 1 1
Estradiol−6, E6 Chemiluminescence pg/mL

Mean 90.94 90.93 242.6 242.0 694.1 685.5
SD
CV
1 5.87
6.5
6.01
6.6
2 11.13
4.6
10.11
4.2
3 29.03
4.2
26.59
3.9
# Points 68 635 68 634 68 636
# Labs 2 2 2 2 2 2

Estradiol−6, E6 Chemiluminescence pg/mL

Mean 90.94 90.93 242.6 242.0 694.1 685.5
SD
CV
1 5.87
6.5
6.01
6.6
2 11.13
4.6
10.11
4.2
3 29.03
4.2
26.59
3.9
# Points 68 635 68 634 68 636
# Labs 2 2 2 2 2 2
Estriol, Free Chemiluminescence ng/mL

Mean 1.26 1.26 3.69 3.69 −− −−
SD
CV
1 0.028
2.2
0.028
2.2
2 0.085
2.3
0.085
2.3
3 −−
−−
−−
−−
# Points 2 2 2 2 −− −−
# Labs 1 1 1 1

Mean 1.42 1.45 4.00 4.13 6.95 6.64
SD
CV
1 0.142
10.0
0.161
11.1
2 0.384
9.6
0.459
11.1
3 0.000
0.0
0.155
2.3
# Points 139 691 148 721 1 6
# Labs 6 6 6 6 1 1

Mean 1.19 1.26 4.69 4.80 12.91 12.86
SD
CV
1 0.198
16.6
0.210
16.7
2 0.516
11.0
0.529
11.0
3 0.864
6.7
0.837
6.5
# Points 95 266 91 269 19 24
# Labs 7 8 7 8 3 3
Siemens IMMULITE 2000/2500/XPi • Siemens IMMULITE UE3, Lots 401+ (2000), 320+ (1000)
Mean 1.05 1.10 4.26 4.29 12.00 12.00
SD
CV
1 0.132
12.5
0.115
10.4
0.353
8.3
20.306
7.1
3 0.000
0.0
0.004
0.0
# Points 45 138 55 145 11 15
# Labs 2 2 3 3 1 2
Siemens IMMULITE 2000/2500/XPi • Siemens IMMULITE Unconjugated Estriol, UE3

Mean 1.20 1.17 4.63 4.52 −− 11.60
SD
CV
1 0.186
15.5
0.165
14.1
0.424
9.2
2
0.401
8.9
3 −−
−−
0.303
2.6
# Points 68 224 67 179 −− 6
# Labs 3 3 3 3 1
Mean 1.35 1.35 4.82 4.82 11.20 11.20
SD
CV
1 0.300
22.2
0.300
22.2
2 0.530
11.0
0.530
11.0
3 0.000
0.0
0.000
0.0
# Points 5 5 5 5 2 2
# Labs 1 1 1 1 1 1

Mean 1.26 1.26 3.92 3.92 9.93 9.93
SD
CV
1 0.072
5.7
0.072
5.7
2 0.146
3.7
0.146
3.7
3 0.219
2.2
0.219
2.2
# Points 3 3 3 3 3 3
# Labs 1 1 1 1 1 1

Mean 1.27 1.33 4.33 4.34 12.12 11.61
SD
CV
1 0.212
16.7
0.216
16.3
2 0.525
12.1
0.527
12.1
3 1.40
11.5
1.97
17.0
# Points 357 1329 371 1324 36 56
# Labs 21 22 22 23 7 9

Estriol, Total Chemiluminescence ng/mL

Mean 1.05 1.10 −− 4.49 11.10 12.64
SD
CV
1 0.190
18.1
0.201
18.4
2 −−
−−
0.437
9.7
3 0.000
0.0
1.05
8.3
# Points 2 23 −− 14 1 36
# Labs 1 1 1 1 1

Mean 1.05 1.10 −− 4.49 11.10 12.64
SD
CV
1 0.190
18.1
0.201
18.4
2 −−
−−
0.437
9.7
3 0.000
0.0
1.05
8.3
# Points 2 23 −− 14 1 36
# Labs 1 1 1 1 1
Ferritin Chemiluminescence ng/mL

1drop
Mean 51.36 52.57 −− −− 302.4 314.5
SD
CV
1 0.780
1.5
1.96
3.7
2 −−
−−
−−
−−
3 8.86
2.9
14.12
4.5
# Points 24 187 −− −− 24 207
# Labs 1 1 1 1

Mean 88.82 87.81 284.1 282.1 745.8 739.5
SD
CV
1 4.11
4.6
4.20
4.8
2 13.53
4.8
13.73
4.9
3 42.65
5.7
43.96
5.9
# Points 1760 5612 1634 4797 1570 5156
# Labs 62 70 55 65 56 64
Abbott ARCHITECT/Alinity (c, i, ci models) • Abbott ARCHITECT Ferritin (7K59)

Mean 91.02 87.55 286.5 276.7 756.7 724.2
SD
CV
1 4.80
5.3
5.84
6.7
2
14.53
5.1
17.91
6.5
3 47.86
6.3
57.44
7.9
# Points 275 1390 228 774 266 1373
# Labs 13 16 11 13 12 15

Mean 104.2 104.5 393.4 395.8 922.3 908.1
SD
CV
1 3.64
3.5
3.94
3.8
2 28.29
7.2
18.35
4.6
3 0.000
0.0
20.05
2.2
# Points 14 53 13 53 1 2
# Labs 2 2 2 2 1 1

Mean 54.80 53.32 145.1 142.5 356.7 349.8
SD
CV
1 3.02
5.5
3.35
6.3
2 8.14
5.6
9.32
6.5
3 25.71
7.2
25.44
7.3
# Points 373 1219 228 844 334 1158
# Labs 21 24 14 16 19 22

Mean 51.35 51.18 136.9 137.0 333.6 335.3
SD
CV
1 4.03
7.9
3.95
7.7
2 10.50
7.7
10.39
7.6
3 27.54
8.3
27.35
8.2
# Points 709 2560 768 2624 755 2315
# Labs 36 40 37 40 36 38
DiaSorin LIAISON/XL
Mean 79.12 78.38 205.8 201.0 471.6 464.8
SD
CV
1 4.78
6.0
5.49
7.0
2 10.93
5.3
11.87
5.9
3 25.74
5.5
50.39
10.8
# Points 32 104 29 93 4 6
# Labs 3 4 2 3 1 2
DiaSorin LIAISON/XL • DiaSorin LIAISON Ferritin, REF 313551

Mean −− 85.36 −− 275.7 −− −−
SD
CV
1 −−
−−
0.000
0.0
2 −−
−−
0.000
0.0
3 −−
−−
−−
−−
# Points −− 1 −− 1 −− −−
# Labs 1 1


Mindray CL Series
Mean −− 67.78 −− 221.1 −− −−
SD
CV
1 −−
−−
2.11
3.1
2 −−
−−
8.77
4.0
3 −−
−−
−−
−−
# Points −− 70 −− 169 −− −−
# Labs 1 2
Mindray CL−900 Series

Mean 61.09 63.56 201.2 205.5 −− −−
SD
CV
1 2.86
4.7
4.30
6.8
2 9.99
5.0
16.71
8.1
3 −−
−−
−−
−−
# Points 23 63 24 64 −− −−
# Labs 2 2 2 2
Roche cobas u 601

Mean −− 89.74 −− 212.4 −− −−
SD
CV
1 −−
−−
2.89
3.2
2 −−
−−
14.25
6.7
3 −−
−−
−−
−−
# Points −− 30 −− 30 −− −−
# Labs 1 1

Mean 58.33 58.27 157.0 154.6 385.1 389.5
SD
CV
1 4.94
8.5
4.87
8.4
2 12.52
8.0
13.86
9.0
3 19.32
5.0
29.76
7.6
# Points 78 94 81 97 62 83
# Labs 4 4 4 4 4 4

Mean 57.57 57.72 154.3 155.8 390.9 391.2
SD
CV
1 3.19
5.5
3.19
5.5
2 9.98
6.5
10.07
6.5
3 27.87
7.1
28.15
7.2
# Points 892 2737 963 2681 723 2046
# Labs 37 45 37 44 34 40

Mean 53.96 53.88 144.4 145.3 357.9 360.7
SD
CV
1 3.21
6.0
2.99
5.5
2 9.12
6.3
8.90
6.1
3 26.34
7.4
24.89
6.9
# Points 650 2005 686 2049 606 1945
# Labs 20 20 20 20 19 19

Mean −− 82.00 −− 183.7 476.0 437.8
SD
CV
1 −−
−−
7.07
8.6
2 −−
−−
2.52
1.4
3 0.000
0.0
29.51
6.7
# Points −− 2 −− 3 1 4
# Labs 1 1 1 1

Mean 60.06 59.95 155.5 156.7 377.0 379.7
SD
CV
1 0.844
1.4
1.18
2.0
2 2.98
1.9
3.30
2.1
3 9.11
2.4
10.72
2.8
# Points 23 35 23 35 23 35
# Labs 1 1 1 1 1 1

Mean 70.40 68.73 160.3 156.1 384.7 377.9
SD
CV
1 4.87
6.9
5.08
7.4
2 10.29
6.4
11.50
7.4
3 30.27
7.9
28.17
7.5
# Points 55 188 55 188 54 187
# Labs 4 4 4 4 4 4

Mean 70.45 71.15 211.9 217.0 517.8 534.8
SD
CV
1 3.80
5.4
6.86
9.6
2 19.20
9.1
24.84
11.4
3 34.92
6.7
63.11
11.8
# Points 35 73 37 75 32 63
# Labs 3 4 3 4 2 3


Mean 54.08 54.66 130.4 132.2 316.6 319.7
SD
CV
1 2.66
4.9
2.83
5.2
2 6.90
5.3
6.93
5.2
3 17.66
5.6
17.84
5.6
# Points 1071 5014 945 4326 986 4786
# Labs 53 64 49 58 49 57

Mean 66.75 65.84 190.3 185.0 484.3 477.2
SD
CV
1 16.87
25.3
16.25
24.7
2 68.28
35.9
65.95
35.6
3 192.4
39.7
189.4
39.7
# Points 6014 21437 5714 18903 5441 19366
# Labs 262 305 241 281 240 272
Ferritin EIA ng/mL

Roche cobas c 303/503 • Roche Elecsys Ferritin, REF 07027273
Mean 91.01 92.36 216.9 221.8 440.7 449.2
SD
CV
1 4.17
4.6
4.57
4.9
2
8.70
4.0
9.09
4.1
3 14.63
3.3
19.06
4.2
# Points 27 59 27 59 27 59
# Labs 1 1 1 1 1 1

Mean 89.18 89.06 208.8 208.6 460.3 466.8
SD
CV
1 2.45
2.8
3.42
3.8
2 5.48
2.6
7.20
3.5
3 11.93
2.6
20.34
4.4
# Points 158 728 117 461 107 657
# Labs 6 7 4 5 5 6
Tosoh AIA Models

Mean 53.44 53.89 125.8 125.9 301.4 299.9
SD
CV
1 1.61
3.0
1.90
3.5
2 3.23
2.6
4.57
3.6
3 5.52
1.8
9.47
3.2
# Points 22 63 22 71 22 69
# Labs 1 2 1 2 1 2

Mean 85.62 86.68 199.1 200.0 434.5 450.8
SD
CV
1 11.45
13.4
9.93
11.5
2 29.49
14.8
28.61
14.3
3 55.85
12.9
51.00
11.3
# Points 207 850 166 591 156 785
# Labs 8 10 6 8 7 9
Ferritin Electrochemiluminescence (ECL) ng/mL

Mean 90.65 90.72 208.5 207.0 457.1 451.4
SD
CV
1 5.12
5.7
5.06
5.6
2 13.23
6.3
11.36
5.5
3 27.17
5.9
26.43
5.9
# Points 914 3746 921 3663 781 3441
# Labs 35 43 34 41 32 40

Mean 85.62 85.44 201.3 200.7 433.9 430.2
SD
CV
1 5.94
6.9
5.49
6.4
2 15.07
7.5
13.38
6.7
3 20.64
4.8
26.50
6.2
# Points 1003 2887 910 2730 267 708
# Labs 25 27 22 24 15 18
Roche cobas e 402/801 • Roche Elecsys Ferritin, REF 07027273

Mean 85.36 85.72 201.0 199.1 426.6 424.1
SD
CV
1 6.05
7.1
6.15
7.2
2
16.85
8.4
17.28
8.7
3 23.25
5.5
20.51
4.8
# Points 523 1585 314 868 355 1007
# Labs 13 13 8 8 9 9

Ferritin Electrochemiluminescence (ECL) ng/mL

Mean 87.15 87.78 204.2 204.7 453.9 450.1
SD
CV
1 6.22
7.1
6.18
7.0
2 15.29
7.5
14.97
7.3
3 33.76
7.4
30.26
6.7
# Points 333 1018 333 1022 250 773
# Labs 24 28 24 27 19 24
Roche Elecsys / cobas e 411 Series • Roche hCG + B Ref 03271749

Mean −− −− −− −− −− 464.6
SD
CV
1 −−
−−
−−
−−
−−
−−
2 −−
−−
3 −−
−−
18.38
4.0
# Points −− −− −− −− −− 20
# Labs 1

Mean 87.41 87.89 204.3 203.8 446.3 444.1
SD
CV
1 6.19
7.1
6.03
6.9
2 15.07
7.4
13.60
6.7
3 29.62
6.6
28.39
6.4
# Points 2773 9236 2478 8283 1653 5929
# Labs 97 111 88 100 75 91
Ferritin FIA ng/mL

Mean 67.67 67.73 154.2 153.5 353.6 354.8
SD
CV
1 4.24
6.3
5.98
8.8
2 12.08
7.8
14.48
9.4
3 30.14
8.5
33.82
9.5
# Points 43 113 37 102 42 110
# Labs 3 3 3 3 3 3

Mean 67.67 67.73 154.2 153.5 353.6 354.8
SD
CV
1 4.24
6.3
5.98
8.8
2 12.08
7.8
14.48
9.4
3 30.14
8.5
33.82
9.5
# Points 43 113 37 102 42 110
# Labs 3 3 3 3 3 3
Ferritin Immunoturbidimetric ng/mL

Abbott ARCHITECT/Alinity (c, i, ci models) • Abbott ARCHITECT Quantia Ferritin (6K41)
Mean 87.34 87.37 281.1 283.9 716.3 734.7
SD
CV
1 2.69
3.1
3.79
4.3
2
14.78
5.3
11.41
4.0
3 56.00
7.8
45.55
6.2
# Points 6 20 7 21 9 21
# Labs 1 2 1 2 1 2

Mean 80.56 79.73 −− −− 328.7 319.1
SD
CV
1 6.95
8.6
5.49
6.9
2 −−
−−
−−
−−
3 15.80
4.8
14.02
4.4
# Points 88 458 −− −− 89 458
# Labs 3 3 3 3
BioSystems BA400
Mean −− 80.36 −− −− −− 329.2
SD
CV
1 −−
−−
8.92
11.1
2 −−
−−
−−
−−
3 −−
−−
25.05
7.6
# Points −− 35 −− −− −− 35
# Labs 2 2
Mindray BS Series
Mean 63.23 63.19 128.6 128.9 −− −−
SD
CV
1 3.51
5.5
3.10
4.9
2 3.00
2.3
3.26
2.5
3 −−
−−
−−
−−
# Points 27 37 26 38 −− −−
# Labs 1 1 1 1

Ferritin Immunoturbidimetric ng/mL

Mean −− −− 192.7 198.6 405.2 417.3
SD
CV
1 −−
−−
−−
−−
2 5.63
2.9
10.17
5.1
3 12.66
3.1
24.53
5.9
# Points −− −− 39 166 39 168
# Labs 2 2 2 2

Mean 77.03 78.94 178.1 194.8 376.0 356.6
SD
CV
1 9.76
12.7
7.15
9.1
2 45.79
25.7
39.77
20.4
3 98.80
26.3
81.67
22.9
# Points 121 550 72 225 137 682
# Labs 5 8 4 5 6 9
Folate Chemiluminescence ng/mL

1drop
Mean 2.89 2.83 −− −− 16.65 16.94
SD
CV
1 0.240
8.3
0.220
7.8
2 −−
−−
−−
−−
3 1.06
6.4
1.28
7.6
# Points 23 205 −− −− 23 204
# Labs 1 1 1 1

Mean 4.43 4.53 11.19 11.33 19.16 19.30
SD
CV
1 0.585
13.2
0.619
13.7
2 1.08
9.6
1.11
9.8
3 1.26
6.6
1.31
6.8
# Points 1298 4012 1303 3953 1070 3260
# Labs 55 67 51 63 44 58

Mean 2.52 2.59 6.02 6.06 −− −−
SD
CV
1 0.120
4.8
0.188
7.3
2 0.200
3.3
0.312
5.1
3 −−
−−
−−
−−
# Points 8 43 8 43 −− −−
# Labs 1 1 1 1
Beckman Coulter Access, LXi 725, DxC 600i IA Systems • Beckman Coulter Access Folate (REF A14208)
Mean 3.76 3.76 −− −− 15.59 15.59
SD
CV
1 0.157
4.2
0.157
4.2
2
−−
−−
−−
−−
3 0.642
4.1
0.642
4.1
# Points 31 31 −− −− 31 31
# Labs 1 1 1 1
Beckman Coulter Access, LXi 725, DxC 600i IA Systems • Beckman Coulter Access/DxI Folate (REF A98032)
Mean 3.70 3.76 9.45 9.30 15.33 15.15
SD
CV
1 0.205
5.5
0.186
5.0
2
0.331
3.5
0.357
3.8
3 1.05
6.9
0.827
5.5
# Points 68 277 66 233 70 280
# Labs 4 6 3 3 4 6
Beckman Coulter UniCel DxI Series • Beckman Coulter Access Folate (REF A14208)
Mean −− −− 9.49 9.53 −− −−
SD
CV
1 −−
−−
−−
−−
2
0.380
4.0
0.495
5.2
3 −−
−−
−−
−−
# Points −− −− 27 75 −− −−
# Labs 1 1
Mean 3.82 3.90 9.48 9.60 15.25 15.36
SD
CV
1 0.409
10.7
0.485
12.4
2
0.671
7.1
0.751
7.8
3 1.28
8.4
1.25
8.2
# Points 403 1834 506 2039 534 2046
# Labs 19 22 23 24 24 26
Beckman Coulter UniCel DxI Series • hCG, WHO 5th International Std 07/364
Mean 3.83 3.79 9.56 9.43 15.54 15.44
SD
CV
1 0.347
9.1
0.339
8.9
2
1.10
11.6
1.10
11.6
3 0.992
6.4
1.09
7.1
# Points 25 29 55 62 45 47
# Labs 2 2 3 3 3 3


DiaSorin LIAISON/XL
Mean 3.69 4.07 7.93 8.38 −− −−
SD
CV
1 1.13
30.6
1.07
26.3
2 1.39
17.6
1.36
16.2
3 −−
−−
−−
−−
# Points 12 21 12 27 −− −−
# Labs 1 1 1 1
Mindray CL Series
Mean 3.09 3.55 11.04 12.53 −− −−
SD
CV
1 0.289
9.4
0.423
11.9
2 0.916
8.3
1.36
10.9
3 −−
−−
−−
−−
# Points 30 121 31 116 −− −−
# Labs 2 3 2 3

Mean 2.12 2.18 6.11 6.20 10.16 10.27
SD
CV
1 0.326
15.4
0.365
16.7
2 0.583
9.5
0.628
10.1
3 0.982
9.7
1.07
10.4
# Points 1254 2180 1299 2197 1205 2065
# Labs 31 34 31 34 30 33
Siemens ADVIA Centaur Systems • Alternate Formulation/Standardization

Mean −− 4.61 −− 8.99 −− −−
SD
CV
1 −−
−−
0.000
0.0
−−
−−
2 0.000
0.0
3 −−
−−
−−
−−
# Points −− 1 −− 1 −− −−
# Labs 1 1

Mean 2.60 2.76 6.93 7.27 11.12 11.54
SD
CV
1 0.460
17.7
0.406
14.7
2 0.767
11.1
0.712
9.8
3 1.09
9.8
1.09
9.4
# Points 201 990 197 926 183 887
# Labs 7 7 7 7 7 7

Mean 2.27 2.20 6.03 5.78 10.09 9.58
SD
CV
1 0.214
9.4
0.268
12.2
2 0.341
5.6
0.402
7.0
3 0.702
7.0
0.760
7.9
# Points 154 520 127 424 102 427
# Labs 7 7 6 6 6 6

Mean 2.23 2.21 5.59 5.50 9.23 9.07
SD
CV
1 0.171
7.7
0.163
7.4
2 0.258
4.6
0.278
5.1
3 0.336
3.6
0.437
4.8
# Points 24 34 24 34 24 34
# Labs 1 1 1 1 1 1
Siemens IMMULITE 2000/XPi

Mean 3.08 2.98 7.41 7.04 11.05 10.85
SD
CV
1 0.335
10.9
0.335
11.2
2 0.974
13.1
0.927
13.2
3 1.32
12.0
1.25
11.5
# Points 49 103 49 103 26 73
# Labs 2 2 2 2 1 1

Mean 1.44 1.45 3.89 3.94 6.46 6.55
SD
CV
1 0.233
16.2
0.192
13.3
2 0.718
18.4
0.569
14.4
3 1.20
18.5
0.867
13.2
# Points 104 268 105 269 105 265
# Labs 7 7 7 7 7 7

Mean 2.54 2.54 8.04 7.95 15.59 15.37
SD
CV
1 0.285
11.2
0.291
11.5
2 0.819
10.2
0.811
10.2
3 1.48
9.5
1.57
10.2
# Points 427 2134 423 1965 330 1789
# Labs 20 28 20 28 16 22


Mean 3.15 3.33 8.41 8.84 14.10 14.82
SD
CV
1 1.12
35.6
1.10
33.1
2 2.41
28.6
2.33
26.4
3 4.13
29.3
3.86
26.1
# Points 4086 12773 4177 12404 3703 11361
# Labs 159 188 156 181 142 169
Folate EIA ng/mL

Tosoh AIA−2000
Mean 4.28 4.35 8.92 9.30 13.79 14.26
SD
CV
1 0.358
8.4
0.382
8.8
2 0.548
6.1
0.644
6.9
3 0.742
5.4
0.969
6.8
# Points 22 66 22 66 22 67
# Labs 1 1 1 1 1 1

Mean 4.28 4.35 8.92 9.30 13.79 14.26
SD
CV
1 0.358
8.4
0.382
8.8
2 0.548
6.1
0.644
6.9
3 0.742
5.4
0.969
6.8
# Points 22 66 22 66 22 67
# Labs 1 1 1 1 1 1
Folate Electrochemiluminescence (ECL) ng/mL

Mean 2.62 2.79 7.09 7.19 12.19 12.32
SD
CV
1 0.384
14.7
0.432
15.5
2 0.733
10.3
0.766
10.7
3 1.58
13.0
1.43
11.6
# Points 104 231 135 322 155 330
# Labs 10 11 10 10 11 11
Roche cobas 6000/8000/c 311 • Roche ECL Folate III (REF 07559992)
Mean 2.33 2.43 6.73 6.80 11.54 11.56
SD
CV
1 0.259
11.1
0.668
27.5
2
0.716
10.6
1.01
14.9
3 1.37
11.9
1.39
12.0
# Points 121 465 151 649 151 613
# Labs 10 12 10 12 11 12
Roche cobas 6000/8000/c 311 • Roche Elecsys Folate III REF 07027290
Mean 2.41 2.26 7.07 7.00 12.20 12.29
SD
CV
1 0.241
10.0
0.263
11.6
2
0.420
5.9
0.429
6.1
3 0.612
5.0
0.647
5.3
# Points 58 120 58 109 63 111
# Labs 2 2 2 2 2 2
Roche cobas c 303/503 • Roche Elecsys Folate III REF 07027290

Mean 2.58 2.59 7.73 7.64 13.16 13.15
SD
CV
1 0.124
4.8
0.149
5.8
2
0.333
4.3
0.317
4.1
3 0.685
5.2
0.605
4.6
# Points 14 33 14 33 14 33
# Labs 1 1 1 1 1 1

Mean 2.48 2.60 7.19 7.38 12.96 12.87
SD
CV
1 0.381
15.4
0.440
17.0
2 0.610
8.5
0.687
9.3
3 0.793
6.1
0.994
7.7
# Points 430 1189 244 603 419 1236
# Labs 16 18 13 14 16 17
Roche cobas e 402/801 • Roche ECL Folate III (REF 07559992)

Mean −− 2.76 −− 7.26 −− 12.41
SD
CV
1 −−
−−
0.323
11.7
2 −−
−−
0.441
6.1
3 −−
−−
0.603
4.9
# Points −− 64 −− 65 −− 65
# Labs 3 3 3

Folate Electrochemiluminescence (ECL) ng/mL

Roche cobas e 402/801 • Roche Elecsys Folate III REF 07027290
Mean 2.50 2.53 7.77 7.69 13.19 13.05
SD
CV
1 0.349
14.0
0.412
16.3
0.827
10.6
2 0.735
9.6
3 0.876
6.6
0.936
7.2
# Points 467 1346 428 1268 175 357
# Labs 15 17 13 17 8 9
Roche cobas e 402/801 • Roche Elecsys Folate III REF 08324174

Mean 2.34 2.34 7.05 7.35 13.74 13.82
SD
CV
1 0.268
11.5
0.268
11.5
0.540
7.7
2 0.890
12.1
3 0.862
6.3
1.31
9.5
# Points 28 28 61 80 21 40
# Labs 2 2 3 3 2 2

Mean 2.68 2.66 7.42 7.35 14.23 13.48
SD
CV
1 0.290
10.8
0.372
14.0
2 0.622
8.4
0.775
10.5
3 1.68
11.8
1.57
11.6
# Points 36 117 33 90 31 104
# Labs 6 8 6 7 4 5
Roche Elecsys / cobas e 411 Series • Roche ECL Folate III (REF 07559992)
Mean 2.82 2.98 7.81 7.48 13.09 12.84
SD
CV
1 0.520
18.4
0.776
26.1
2
0.698
8.9
1.06
14.2
3 1.03
7.9
1.41
11.0
# Points 7 27 26 160 25 154
# Labs 1 2 2 3 2 3

Mean −− −− 4.97 4.97 −− −−
SD
CV
1 −−
−−
−−
−−
2 0.219
4.4
0.219
4.4
3 −−
−−
−−
−−
# Points −− −− 2 2 −− −−
# Labs 1 1

Mean 2.48 2.56 7.34 7.36 12.69 12.57
SD
CV
1 0.356
14.3
0.471
18.4
2 0.814
11.1
0.867
11.8
3 1.25
9.9
1.30
10.3
# Points 1265 3620 1152 3381 1054 3043
# Labs 63 76 61 73 57 65
Folate Immunoturbidimetric ng/mL

Mean 2.47 2.46 −− −− 10.65 10.59
SD
CV
1 0.348
14.1
0.345
14.1
2 −−
−−
−−
−−
3 0.821
7.7
0.727
6.9
# Points 39 64 −− −− 36 59
# Labs 1 1 1 1

Mean 2.47 2.46 −− −− 10.65 10.59
SD
CV
1 0.348
14.1
0.345
14.1
2 −−
−−
−−
−−
3 0.821
7.7
0.727
6.9
# Points 39 64 −− −− 36 59
# Labs 1 1 1 1
FSH Chemiluminescence mIU/mL

1drop
Mean 7.62 7.62 23.06 23.06 44.31 44.31
SD
CV
1 0.567
7.4
0.567
7.4
2 1.10
4.8
1.10
4.8
3 0.600
1.4
0.600
1.4
# Points 66 66 67 67 57 57
# Labs 3 3 3 3 2 2


Mean 6.82 6.80 21.24 21.23 41.98 41.84
SD
CV
1 0.331
4.8
0.331
4.9
2 1.02
4.8
1.02
4.8
3 2.06
4.9
2.03
4.9
# Points 1996 6123 1856 5539 1748 5309
# Labs 78 91 71 83 72 81

Mean 9.78 9.86 26.76 27.07 45.98 46.97
SD
CV
1 0.424
4.3
0.401
4.1
2 1.89
7.0
1.55
5.7
3 2.29
5.0
2.43
5.2
# Points 11 30 11 65 17 69
# Labs 2 2 2 4 3 4

Mean 8.08 8.16 23.99 23.90 46.41 46.72
SD
CV
1 0.524
6.5
0.551
6.8
2 1.56
6.5
1.66
6.9
3 2.99
6.4
3.01
6.4
# Points 120 560 113 537 103 509
# Labs 14 16 13 15 10 14

Mean 8.27 8.26 24.42 24.25 47.43 47.26
SD
CV
1 0.591
7.1
0.587
7.1
2 1.87
7.7
1.79
7.4
3 3.55
7.5
3.57
7.6
# Points 693 3137 758 2878 829 3332
# Labs 40 51 38 50 43 53
DiaSorin LIAISON/XL
Mean −− 8.89 −− 25.87 −− 62.65
SD
CV
1 −−
−−
0.647
7.3
2 −−
−−
1.10
4.3
3 −−
−−
17.89
28.6
# Points −− 11 −− 3 −− 2
# Labs 1 1 1
DiaSorin LIAISON/XL • DiaSorin LIAISON FSH, REF 312251

Mean 8.60 8.60 30.66 27.64 −− −−
SD
CV
1 0.424
4.9
0.424
4.9
2
4.33
14.1
3.37
12.2
3 −−
−−
−−
−−
# Points 2 2 2 8 −− −−
# Labs 1 1 1 1
Dirui CS Series
Mean −− 6.19 −− 23.55 −− −−
SD
CV
1 −−
−−
0.114
1.8
2 −−
−−
0.925
3.9
3 −−
−−
−−
−−
# Points −− 34 −− 34 −− −−
# Labs 1 1
Mindray CL Series
Mean 8.07 8.08 26.72 26.44 60.42 60.42
SD
CV
1 0.322
4.0
0.295
3.7
2 1.33
5.0
1.17
4.4
3 0.361
0.6
0.361
0.6
# Points 34 44 46 192 2 2
# Labs 2 2 3 4 2 2

Mean 7.11 6.72 23.53 22.35 44.14 44.43
SD
CV
1 0.599
8.4
0.685
10.2
2 1.75
7.4
1.81
8.1
3 2.18
4.9
2.93
6.6
# Points 10 25 11 33 11 33
# Labs 2 3 3 4 3 4

Mean 7.27 7.33 23.12 22.97 48.35 47.79
SD
CV
1 0.573
7.9
0.604
8.2
2 1.23
5.3
1.25
5.4
3 2.88
6.0
3.01
6.3
# Points 193 682 188 551 176 512
# Labs 10 14 10 14 11 15


Siemens ADVIA Centaur Systems • Siemens Centaur/XP FSH, Cal B Lot 41+
Mean 7.13 7.13 22.88 22.99 48.25 48.42
SD
CV
1 0.429
6.0
0.407
5.7
1.04
4.5
2 1.21
5.3
3 2.32
4.8
2.85
5.9
# Points 325 1142 327 1180 279 891
# Labs 15 15 15 15 14 14
Siemens ADVIA Centaur Systems • Siemens Centaur/XP FSH, Cal B Lot<41

Mean 7.20 7.17 22.84 22.70 48.13 47.38
SD
CV
1 0.418
5.8
0.482
6.7
1.09
4.8
2 1.41
6.2
3 2.36
4.9
3.02
6.4
# Points 105 193 122 215 94 192
# Labs 4 4 4 4 4 4

Mean 7.14 6.85 23.20 23.28 49.54 50.86
SD
CV
1 0.340
4.8
0.781
11.4
2 0.990
4.3
1.08
4.6
3 1.73
3.5
3.54
7.0
# Points 31 68 31 68 31 68
# Labs 1 1 1 1 1 1

Mean 6.79 6.85 22.25 22.42 44.73 45.32
SD
CV
1 0.451
6.6
0.457
6.7
2 1.10
4.9
1.22
5.4
3 2.75
6.2
2.85
6.3
# Points 387 1543 414 1569 340 1248
# Labs 15 16 15 16 14 14
Siemens Atellica IM Analyzer • Siemens Centaur/XP FSH, Cal B Lot<41

Mean 7.14 7.44 22.33 22.52 47.42 48.68
SD
CV
1 0.325
4.6
0.421
5.7
0.636
2.8
2 0.875
3.9
3 1.46
3.1
2.07
4.3
# Points 63 625 63 623 63 622
# Labs 2 2 2 2 2 2

Mean 7.35 7.50 21.98 22.57 45.06 46.17
SD
CV
1 0.507
6.9
0.559
7.5
2 1.57
7.2
1.67
7.4
3 3.59
8.0
3.60
7.8
# Points 67 189 68 189 64 183
# Labs 6 6 6 6 5 5

Mean 6.57 6.69 22.72 22.66 46.77 46.39
SD
CV
1 0.858
13.1
0.895
13.4
2 1.97
8.7
2.71
12.0
3 6.02
12.9
7.47
16.1
# Points 24 37 30 51 24 36
# Labs 2 4 2 4 2 4
Tosoh AIA Models

Mean 8.60 9.78 24.98 28.47 46.16 52.60
SD
CV
1 0.265
3.1
1.06
10.9
2 0.870
3.5
2.79
9.8
3 1.45
3.1
5.13
9.8
# Points 5 38 5 34 5 38
# Labs 1 1 1 1 1 1

Mean 5.33 5.41 19.32 19.44 41.50 41.54
SD
CV
1 0.237
4.5
0.258
4.8
2 0.815
4.2
0.819
4.2
3 1.87
4.5
1.83
4.4
# Points 759 3405 675 3089 730 3327
# Labs 47 54 44 50 44 51

Mean 6.91 6.93 22.00 22.00 44.21 44.32
SD
CV
1 0.954
13.8
1.02
14.7
2 2.05
9.3
2.12
9.6
3 3.74
8.5
3.88
8.8
# Points 4891 17954 4787 16924 4573 16430
# Labs 245 288 234 279 233 272

FSH EIA mIU/mL

Roche cobas c 303/503 • Roche Elecsys FSH, REF 08932387
Mean 7.00 7.00 20.99 20.93 40.86 40.72
SD
CV
1 0.113
1.6
0.163
2.3
0.306
1.5
2 0.251
1.2
3 0.488
1.2
0.555
1.4
# Points 27 59 27 59 27 59
# Labs 1 1 1 1 1 1
Tosoh AIA Models

Mean 9.06 9.11 27.32 26.76 51.21 50.12
SD
CV
1 0.150
1.7
0.275
3.0
2 0.588
2.2
0.929
3.5
3 0.975
1.9
1.80
3.6
# Points 22 81 22 81 22 82
# Labs 1 2 1 2 1 2

Mean 7.93 8.22 23.83 24.30 45.51 46.19
SD
CV
1 1.04
13.2
1.07
13.0
2 3.21
13.5
2.98
12.3
3 5.25
11.5
4.86
10.5
# Points 49 140 49 140 49 141
# Labs 2 3 2 3 2 3
FSH Electrochemiluminescence (ECL) mIU/mL

Mean 5.85 5.05 18.24 17.68 35.09 35.73
SD
CV
1 0.000
0.0
0.840
16.6
2 0.000
0.0
1.97
11.2
3 0.000
0.0
4.33
12.1
# Points 1 10 1 10 1 10
# Labs 1 1 1 1 1 1

Mean 7.05 7.06 21.09 21.03 41.05 40.88
SD
CV
1 0.237
3.4
0.252
3.6
2 0.830
3.9
0.895
4.3
3 1.64
4.0
1.82
4.4
# Points 640 1565 771 2141 604 1853
# Labs 41 45 43 47 39 42
Roche cobas 6000/8000/c 311 • Roche Elecsys FSH, REF 08932352

Mean −− 6.87 −− 20.39 −− 43.40
SD
CV
1 −−
−−
0.326
4.8
−−
−−
2 0.611
3.0
3 −−
−−
2.35
5.4
# Points −− 42 −− 19 −− 5
# Labs 1 1 1
Roche cobas 6000/8000/c 311 • Roche Elecsys FSH, REF 08932387

Mean 7.10 7.22 21.92 21.58 42.33 42.69
SD
CV
1 0.430
6.1
0.393
5.4
1.19
5.4
2 1.08
5.0
3 2.54
6.0
2.33
5.5
# Points 21 110 16 98 19 111
# Labs 1 1 1 1 1 1

Mean 7.08 7.11 21.28 21.52 40.98 41.50
SD
CV
1 0.279
3.9
0.316
4.4
2 0.806
3.8
0.963
4.5
3 1.46
3.6
1.73
4.2
# Points 812 2549 600 2120 424 1527
# Labs 29 33 23 27 21 25
Roche cobas e 402/801 • Roche Elecsys FSH, REF 07027346

Mean 6.75 6.80 20.36 20.45 −− −−
SD
CV
1 0.232
3.4
0.227
3.3
0.325
1.6
2 0.546
2.7
3 −−
−−
−−
−−
# Points 14 44 14 45 −− −−
# Labs 1 1 1 1

Mean 7.14 7.32 21.39 21.97 41.88 43.16
SD
CV
1 0.084
1.2
0.218
3.0
0.341
1.6
2 0.632
2.9
3 0.471
1.1
1.49
3.4
# Points 22 47 9 19 13 28
# Labs 1 1 1 1 1 1

FSH Electrochemiluminescence (ECL) mIU/mL

Mean 6.97 6.97 20.79 21.14 40.44 41.12
SD
CV
1 0.121
1.7
0.120
1.7
0.339
1.6
2 0.608
2.9
3 0.833
2.1
1.20
2.9
# Points 26 27 53 103 53 103
# Labs 1 1 2 2 2 2
Mean 7.35 6.95 22.09 21.54 42.58 41.81
SD
CV
1 0.167
2.3
0.457
6.6
2
0.611
2.8
0.862
4.0
3 1.11
2.6
1.29
3.1
# Points 22 109 22 109 22 109
# Labs 1 1 1 1 1 1
Roche cobas u 601

Mean 7.07 7.14 21.09 21.30 41.15 41.57
SD
CV
1 0.120
1.7
0.169
2.4
2 0.350
1.7
0.466
2.2
3 1.05
2.6
1.03
2.5
# Points 7 16 7 17 7 16
# Labs 1 1 1 1 1 1

Mean 7.17 7.29 21.75 22.01 42.62 43.08
SD
CV
1 0.445
6.2
0.434
6.0
2 1.26
5.8
1.27
5.8
3 2.47
5.8
2.57
6.0
# Points 742 2355 784 2594 682 2220
# Labs 45 47 49 53 46 51
Roche Elecsys / cobas e 411 Series • Roche Elecsys FSH, REF 08932352
Mean 6.80 7.02 20.81 21.33 40.58 41.65
SD
CV
1 0.489
7.2
0.465
6.6
1.10
5.3
2 1.22
5.7
3 2.30
5.7
2.40
5.8
# Points 26 75 26 75 26 76
# Labs 1 1 1 1 1 1

Mean 7.09 7.15 21.36 21.53 41.62 41.91
SD
CV
1 0.340
4.8
0.378
5.3
2 1.04
4.9
1.15
5.3
3 2.11
5.1
2.33
5.6
# Points 2333 6949 2303 7350 1851 6058
# Labs 123 134 124 137 114 127
FSH FIA mIU/mL

Mean 7.38 7.50 22.37 22.72 44.54 46.05
SD
CV
1 0.371
5.0
0.450
6.0
2 1.10
4.9
1.38
6.1
3 2.07
4.7
3.21
7.0
# Points 41 121 42 134 44 130
# Labs 3 3 3 4 4 4

Mean 7.38 7.50 22.37 22.72 44.54 46.05
SD
CV
1 0.371
5.0
0.450
6.0
2 1.10
4.9
1.38
6.1
3 2.07
4.7
3.21
7.0
# Points 41 121 42 134 44 130
# Labs 3 3 3 4 4 4
FSH FPIA mIU/mL

Mean 7.00 7.00 21.21 21.21 42.77 42.77
SD
CV
1 0.186
2.7
0.186
2.7
2 0.775
3.7
0.775
3.7
3 1.05
2.5
1.05
2.5
# Points 4 4 4 4 4 4
# Labs 1 1 1 1 1 1

FSH FPIA mIU/mL

Mean 7.00 7.00 21.21 21.21 42.77 42.77
SD
CV
1 0.186
2.7
0.186
2.7
2 0.775
3.7
0.775
3.7
3 1.05
2.5
1.05
2.5
# Points 4 4 4 4 4 4
# Labs 1 1 1 1 1 1
Gentamicin Chemiluminescence µg/mL

Mean 1.98 1.97 4.50 4.42 6.17 6.14
SD
CV
1 0.048
2.5
0.068
3.4
2 0.210
4.7
0.174
3.9
3 0.172
2.8
0.194
3.2
# Points 9 18 4 15 6 15
# Labs 2 2 1 1 2 2

Mean 1.98 1.97 4.50 4.42 6.17 6.14
SD
CV
1 0.048
2.5
0.068
3.4
2 0.210
4.7
0.174
3.9
3 0.172
2.8
0.194
3.2
# Points 9 18 4 15 6 15
# Labs 2 2 1 1 2 2
Gentamicin EIA µg/mL

Mean 2.15 2.13 4.81 4.81 6.53 6.47
SD
CV
1 0.153
7.1
0.141
6.6
2 0.426
8.8
0.382
7.9
3 0.609
9.3
0.541
8.4
# Points 80 195 81 196 82 197
# Labs 2 2 2 2 2 2

Mean 1.95 2.14 4.64 4.92 6.26 6.66
SD
CV
1 0.140
7.2
0.179
8.4
2 0.170
3.7
0.261
5.3
3 0.220
3.5
0.332
5.0
# Points 91 576 92 575 94 579
# Labs 1 1 1 1 1 1
Roche cobas c 303/503 • Roche cobas CEDIA Gentamicin II

Mean 2.12 2.11 −− −− 6.62 6.57
SD
CV
1 0.094
4.4
0.107
5.1
2 −−
−−
−−
−−
3 0.214
3.2
0.248
3.8
# Points 33 58 −− −− 32 57
# Labs 1 1 1 1

Mean 2.07 2.04 4.47 4.34 5.99 5.75
SD
CV
1 0.080
3.9
0.096
4.7
2 0.200
4.5
0.188
4.3
3 0.180
3.0
0.267
4.6
# Points 23 118 20 114 22 115
# Labs 1 1 1 1 1 1

Mean 2.06 2.12 4.70 4.82 6.38 6.50
SD
CV
1 0.161
7.8
0.162
7.6
2 0.326
6.9
0.342
7.1
3 0.443
6.9
0.473
7.3
# Points 227 947 193 885 230 948
# Labs 5 5 4 4 5 5
Gentamicin Immunoturbidimetric µg/mL

Mean 2.24 2.18 4.90 4.84 6.50 6.40
SD
CV
1 0.140
6.2
0.205
9.4
2 0.141
2.9
0.202
4.2
3 0.245
3.8
0.268
4.2
# Points 7 13 7 13 7 13
# Labs 2 2 2 2 2 2

Gentamicin Immunoturbidimetric µg/mL

Mean −− 2.42 −− 5.24 −− 6.92
SD
CV
1 −−
−−
0.220
9.1
2 −−
−−
0.349
6.7
3 −−
−−
0.342
4.9
# Points −− 416 −− 417 −− 413
# Labs 1 1 1

Mean 1.75 1.72 4.19 4.16 5.81 5.75
SD
CV
1 0.123
7.0
0.162
9.4
2 0.138
3.3
0.182
4.4
3 0.163
2.8
0.265
4.6
# Points 68 441 66 420 67 403
# Labs 2 2 2 2 2 2

Mean 2.58 2.57 −− −− 7.50 7.37
SD
CV
1 0.203
7.9
0.239
9.3
2 −−
−−
−−
−−
3 0.434
5.8
0.407
5.5
# Points 32 84 −− −− 32 83
# Labs 2 2 2 2

Mean 2.03 2.11 4.26 4.70 6.37 6.44
SD
CV
1 0.407
20.1
0.411
19.5
2 0.251
5.9
0.602
12.8
3 0.818
12.9
0.703
10.9
# Points 107 954 73 850 106 912
# Labs 6 7 4 5 6 7
Gentamicin KIMS (Roche) µg/mL

Mean 1.46 1.46 3.14 3.14 4.22 4.22
SD
CV
1 0.110
7.6
0.110
7.6
2 0.165
5.3
0.165
5.3
3 0.163
3.9
0.163
3.9
# Points 28 28 27 27 27 27
# Labs 1 1 1 1 1 1
Roche cobas c 303/503 • Roche GENT2, REF 08057770

Mean 1.63 1.63 −− −− 4.45 4.45
SD
CV
1 0.000
0.0
0.000
0.0
2 −−
−−
−−
−−
3 0.000
0.0
0.000
0.0
# Points 1 1 −− −− 1 1
# Labs 1 1 1 1

Mean 1.46 1.46 3.14 3.14 4.23 4.23
SD
CV
1 0.113
7.7
0.113
7.7
2 0.165
5.3
0.165
5.3
3 0.166
3.9
0.166
3.9
# Points 29 29 27 27 28 28
# Labs 2 2 1 1 2 2
hCG Chemiluminescence mIU/mL

1drop
Mean 6.45 6.73 26.88 26.88 186.0 189.7
SD
CV
1 0.400
6.2
0.551
8.2
2 0.878
3.3
0.878
3.3
3 7.16
3.8
11.77
6.2
# Points 34 299 57 57 88 344
# Labs 1 2 2 2 3 4
Abbott Alinity i
Mean 5.41 5.40 31.31 31.34 216.2 217.0
SD
CV
1 0.523
9.7
0.524
9.7
2 1.99
6.4
2.17
6.9
3 9.66
4.5
9.54
4.4
# Points 1268 3518 1155 3396 1186 3304
# Labs 51 59 47 56 51 59


Mean 5.26 5.27 30.53 30.01 212.4 213.9
SD
CV
1 0.531
10.1
0.526
10.0
2 1.90
6.2
1.86
6.2
3 10.51
4.9
10.93
5.1
# Points 606 2626 403 1258 390 2022
# Labs 32 41 22 28 23 29

Mean 5256 5237 32003 31108 −− −−
SD
CV
1 716.1
13.6
633.2
12.1
2 2616
8.2
2574
8.3
3 −−
−−
−−
−−
# Points 33 84 31 82 −− −−
# Labs 1 1 1 1

Mean 4.37 4.23 27.38 27.46 187.7 188.1
SD
CV
1 0.157
3.6
0.177
4.2
2 2.03
7.4
1.73
6.3
3 6.92
3.7
10.96
5.8
# Points 7 24 17 63 23 65
# Labs 1 1 2 3 2 3

Mean 5.49 5.44 30.10 29.99 204.7 206.9
SD
CV
1 0.365
6.7
0.408
7.5
2 1.89
6.3
1.81
6.0
3 15.33
7.5
15.07
7.3
# Points 348 1052 352 1034 326 1003
# Labs 18 21 18 21 18 21
Beckman Coulter Access, LXi 725, DxC 600i IA Systems • hCG, WHO 5th International Std 07/364
Mean 5.52 5.50 29.58 29.80 201.2 204.0
SD
CV
1 0.340
6.2
0.281
5.1
2
1.70
5.8
1.50
5.0
3 12.73
6.3
10.92
5.4
# Points 139 379 105 310 90 294
# Labs 10 10 8 8 8 8

Mean 5.53 5.53 29.61 29.66 204.3 204.5
SD
CV
1 0.433
7.8
0.394
7.1
2 1.47
5.0
1.60
5.4
3 13.37
6.5
13.29
6.5
# Points 507 2208 545 2259 544 2069
# Labs 20 22 19 21 20 20
Beckman Coulter UniCel DxI Series • hCG, WHO 5th International Std 07/364
Mean 5.48 5.47 28.92 29.16 203.2 203.3
SD
CV
1 0.300
5.5
0.328
6.0
2
2.53
8.8
2.10
7.2
3 10.00
4.9
10.20
5.0
# Points 328 796 494 953 466 952
# Labs 23 23 26 27 27 27
DiaSorin LIAISON/XL
Mean 4.46 3.98 29.83 28.43 194.1 191.6
SD
CV
1 1.20
26.8
1.08
27.2
2 1.74
5.8
2.37
8.3
3 11.56
6.0
11.71
6.1
# Points 16 34 11 28 13 28
# Labs 3 3 2 2 2 2
Dirui CS Series
Mean −− 6.59 −− 29.04 −− −−
SD
CV
1 −−
−−
0.284
4.3
2 −−
−−
1.29
4.4
3 −−
−−
−−
−−
# Points −− 36 −− 34 −− −−
# Labs 1 1
Mindray CL Series
Mean 5.37 4.26 28.13 25.01 172.7 185.5
SD
CV
1 0.556
10.3
1.28
30.1
2 2.53
9.0
2.96
11.8
3 17.65
10.2
24.31
13.1
# Points 32 135 44 272 28 52
# Labs 3 4 4 6 3 3


Mean 4.32 4.52 23.12 23.45 −− −−
SD
CV
1 0.547
12.7
0.667
14.8
2 3.35
14.5
3.20
13.6
3 −−
−−
−−
−−
# Points 21 57 22 58 −− −−
# Labs 2 2 2 2

Mean 7.03 7.08 31.24 31.91 208.8 215.0
SD
CV
1 0.791
11.3
0.685
9.7
2 2.68
8.6
2.23
7.0
3 16.18
7.7
14.63
6.8
# Points 105 408 102 408 93 426
# Labs 5 5 6 6 6 7

Mean 6.99 6.82 32.71 32.61 220.7 220.0
SD
CV
1 1.20
17.1
1.11
16.3
2 2.45
7.5
2.51
7.7
3 12.56
5.7
13.31
6.1
# Points 330 823 334 800 330 798
# Labs 19 22 20 24 19 21

Mean 6.25 6.59 29.71 29.86 202.3 211.5
SD
CV
1 0.420
6.7
0.694
10.5
2 1.18
4.0
1.83
6.1
3 6.19
3.1
13.44
6.4
# Points 31 67 32 68 32 68
# Labs 1 1 1 1 1 1

Mean 6.50 6.61 32.56 32.23 220.2 222.7
SD
CV
1 0.596
9.2
0.652
9.9
2 1.83
5.6
1.85
5.8
3 11.09
5.0
12.27
5.5
# Points 529 2436 436 2235 552 2347
# Labs 20 21 16 17 20 20

Mean 6.56 6.86 −− −− 174.2 179.4
SD
CV
1 0.500
7.6
0.346
5.0
2 −−
−−
−−
−−
3 4.46
2.6
6.08
3.4
# Points 64 577 −− −− 62 568
# Labs 2 2 2 2

Mean 7.91 7.90 27.34 27.26 176.3 179.2
SD
CV
1 0.852
10.8
1.23
15.6
2 3.10
11.3
3.22
11.8
3 16.60
9.4
20.03
11.2
# Points 194 485 228 532 144 366
# Labs 12 14 12 14 11 13

Mean 7.77 7.60 −− 27.48 208.8 219.9
SD
CV
1 0.849
10.9
1.05
13.9
2 −−
−−
2.54
9.2
3 11.90
5.7
10.38
4.7
# Points 9 38 −− 13 4 35
# Labs 2 3 2 1 2
Tosoh AIA Models

Mean 7.22 7.24 27.78 28.72 178.6 181.4
SD
CV
1 0.172
2.4
0.434
6.0
2 0.704
2.5
1.70
5.9
3 5.07
2.8
7.86
4.3
# Points 22 186 22 186 22 186
# Labs 1 1 1 1 1 1

Mean 7.22 7.24 27.02 27.04 186.6 187.9
SD
CV
1 0.411
5.7
0.417
5.8
2 1.49
5.5
1.51
5.6
3 8.87
4.8
10.80
5.7
# Points 1230 5857 1183 5512 1230 5711
# Labs 64 77 62 71 62 71


VITROS Microwell Series • 2nd Generation
Mean −− −− 33.54 32.61 225.5 230.5
SD
CV
1 −−
−−
−−
−−
2 0.000
0.0
0.636
2.0
3 0.000
0.0
5.29
2.3
# Points −− −− 1 32 1 32
# Labs 1 1 1 1

Mean 38.35 27.25 229.0 168.6 204.5 204.2
SD
CV
1 413.4 332.9
1078.1 1221.9
2 2524
1102.2
2081
1234.6
3 18.23
8.9
18.70
9.2
# Points 5386 20950 4975 18327 5068 19424
# Labs 258 303 238 280 246 280
hCG EIA mIU/mL

Mean 5.53 5.57 32.27 32.30 221.1 217.2
SD
CV
1 0.289
5.2
0.376
6.7
2 1.59
4.9
1.52
4.7
3 7.13
3.2
8.18
3.8
# Points 31 230 31 226 31 227
# Labs 1 1 1 1 1 1

Mean 6.10 6.23 31.95 31.96 233.7 227.4
SD
CV
1 0.410
6.7
0.577
9.3
2 2.13
6.7
2.31
7.2
3 12.34
5.3
14.00
6.2
# Points 18 80 16 80 16 78
# Labs 1 1 1 1 1 1
DiaSorin LIAISON/XL
Mean 6.13 6.07 32.86 33.18 212.3 212.5
SD
CV
1 0.648
10.6
0.593
9.8
2 1.54
4.7
1.46
4.4
3 5.50
2.6
5.15
2.4
# Points 28 43 27 42 27 42
# Labs 1 1 1 1 1 1

Mean 7.04 7.08 28.79 28.29 192.0 191.4
SD
CV
1 0.541
7.7
0.512
7.2
2 1.08
3.8
1.31
4.6
3 6.69
3.5
7.76
4.1
# Points 219 1157 138 908 108 518
# Labs 9 11 6 8 5 7
Tosoh AIA Models

Mean 7.03 7.04 27.84 27.98 181.8 182.0
SD
CV
1 0.177
2.5
0.278
4.0
2 0.758
2.7
1.06
3.8
3 4.30
2.4
6.39
3.5
# Points 77 228 77 217 77 217
# Labs 2 2 2 2 2 2
Tosoh AIA Models • 2nd Generation

Mean −− 6.05 −− 26.48 −− 186.6
SD
CV
1 −−
−−
0.170
2.8
2 −−
−−
0.354
1.3
3 −−
−−
5.61
3.0
# Points −− 4 −− 6 −− 7
# Labs 1 1 1
Tosoh AIA Models • Tosoh AIA Beta HCG

Mean −− 6.90 −− 27.59 −− 174.2
SD
CV
1 −−
−−
0.151
2.2
2 −−
−−
0.472
1.7
3 −−
−−
4.21
2.4
# Points −− 16 −− 16 −− 16
# Labs 1 1 1
Tosoh AIA Models • Tosoh AIA Beta HCG II

Mean −− 7.11 −− −− −− 186.3
SD
CV
1 −−
−−
0.226
3.2
2 −−
−−
−−
−−
3 −−
−−
7.78
4.2
# Points −− 113 −− −− −− 73
# Labs 1 1

hCG EIA mIU/mL

Tosoh AIA Models • Tosoh AIA HCG II
Mean −− 6008 −− 26173 −− 184806
SD
CV
1 −−
−−
269.3
4.5
2 −−
−−
1123
4.3
3 −−
−−
6999
3.8
# Points −− 35 −− 36 −− 38
# Labs 1 1 1

Mean 6.80 117.3 29.46 646.4 197.2 6000
SD
CV
1 0.678
10.0
807.5
688.7
2 2.15
7.3
3974
614.9
3 17.28
8.8
32247
537.5
# Points 373 1902 289 1525 259 1209
# Labs 14 19 11 15 10 15
hCG Electrochemiluminescence (ECL) mIU/mL

Roche cobas 6000/8000/c 311 • Roche Elecsys HCG STAT, REF 08890587
Mean 3.61 3.69 25.54 25.80 189.3 190.1
SD
CV
1 0.208
5.8
0.361
9.8
0.786
3.1
2 1.03
4.0
3 4.27
2.3
7.55
4.0
# Points 69 330 67 325 68 417
# Labs 3 4 3 4 3 4
Roche cobas 6000/8000/c 311 • Roche hCG + B Ref 03271749

Mean 4.67 4.59 26.38 26.12 189.7 188.7
SD
CV
1 0.236
5.0
0.208
4.5
1.08
4.1
2 1.02
3.9
3 7.39
3.9
6.90
3.7
# Points 671 2771 721 2986 663 2729
# Labs 29 33 29 33 27 30
Roche cobas c 303/503 • Roche Elecsys hCG+B Ref 07251025

Mean 4.75 4.67 27.09 26.64 196.3 195.1
SD
CV
1 0.060
1.3
0.125
2.7
0.217
0.8
2 0.958
3.6
3 1.62
0.8
5.37
2.8
# Points 27 56 27 57 27 58
# Labs 1 1 1 1 1 1

Mean 4.42 4.29 25.56 24.79 183.5 183.0
SD
CV
1 0.282
6.4
0.408
9.5
2 1.53
6.0
2.05
8.3
3 8.11
4.4
8.23
4.5
# Points 539 1733 465 1614 124 501
# Labs 17 19 14 16 10 13
Mean 4.39 4.43 24.28 25.26 177.8 188.2
SD
CV
1 0.175
4.0
0.316
7.1
2
0.665
2.7
1.00
4.0
3 8.42
4.7
9.19
4.9
# Points 22 106 22 106 22 105
# Labs 1 1 1 1 1 1
Roche cobas e 402/801 • Roche Elecsys hCG+B Ref 07251025

Mean 4.44 4.44 25.21 25.35 188.7 187.3
SD
CV
1 0.358
8.1
0.323
7.3
1.69
6.7
2 1.42
5.6
3 7.23
3.8
6.85
3.7
# Points 722 2071 553 1648 413 1205
# Labs 29 29 23 23 21 21
Roche cobas e 402/801 • Roche hCG + B Ref 03271749

Mean −− 4.51 −− 25.93 −− 189.4
SD
CV
1 −−
−−
0.070
1.6
2 −−
−−
0.600
2.3
3 −−
−−
3.20
1.7
# Points −− 9 −− 9 −− 8
# Labs 1 1 1

Mean −− 4.55 −− 25.92 −− 190.1
SD
CV
1 −−
−−
0.290
6.4
2 −−
−−
1.26
4.8
3 −−
−−
8.60
4.5
# Points −− 5 −− 5 −− 5
# Labs 1 1 1

hCG Electrochemiluminescence (ECL) mIU/mL

Roche Elecsys / cobas e 411 Series • Roche Elecsys CA 125 II, REF 07026986
Mean 4.14 4.28 −− −− −− 188.7
SD
CV
1 0.000
0.0
0.198
4.6
2 −−
−−
−−
−−
3 −−
−−
0.000
0.0
# Points 1 2 −− −− −− 1
# Labs 1 1 1
Roche Elecsys / cobas e 411 Series • Roche Elecsys HCG STAT, REF 08890587
Mean 4.32 4.34 26.56 26.82 193.8 193.6
SD
CV
1 0.318
7.4
0.280
6.5
2
1.33
5.0
1.30
4.8
3 6.21
3.2
5.81
3.0
# Points 7 9 8 10 9 11
# Labs 2 2 2 2 2 2
Roche Elecsys / cobas e 411 Series • Roche Elecsys hCG+B Ref 07251025
Mean 4.64 4.62 26.95 26.85 191.7 191.8
SD
CV
1 0.165
3.6
0.225
4.9
2
0.984
3.7
0.984
3.7
3 6.29
3.3
6.21
3.2
# Points 16 40 15 38 15 38
# Labs 1 1 1 1 1 1
Roche Elecsys / cobas e 411 Series • Roche STAT hCG Ref 03300811
Mean −− 4.53 −− 26.30 −− 186.5
SD
CV
1 −−
−−
0.000
0.0
2−−
−−
0.000
0.0
3 −−
−−
0.000
0.0
# Points −− 1 −− 1 −− 1
# Labs 1 1 1
Roche Elecsys / cobas e 411 Series • Roche hCG + B Ref 03271749

Mean 4.63 4.67 26.09 26.16 190.4 192.2
SD
CV
1 0.316
6.8
0.415
8.9
2
1.30
5.0
1.39
5.3
3 9.13
4.8
10.14
5.3
# Points 416 1286 387 1029 393 1237
# Labs 22 26 22 25 23 28

Mean 4.51 4.47 25.84 25.67 189.1 188.8
SD
CV
1 0.353
7.8
0.387
8.7
2 1.46
5.7
1.52
5.9
3 8.02
4.2
8.17
4.3
# Points 2490 8410 2265 7819 1734 6308
# Labs 106 119 96 108 89 104
hCG FIA mIU/mL

Mean 5.83 5.85 31.76 30.84 222.8 216.1
SD
CV
1 0.578
9.9
0.571
9.8
2 3.68
11.6
2.56
8.3
3 11.47
5.1
13.89
6.4
# Points 16 108 18 109 17 102
# Labs 2 2 2 2 2 2

Mean 5.83 5.85 31.76 30.84 222.8 216.1
SD
CV
1 0.578
9.9
0.571
9.8
2 3.68
11.6
2.56
8.3
3 11.47
5.1
13.89
6.4
# Points 16 108 18 109 17 102
# Labs 2 2 2 2 2 2
hGH Chemiluminescence ng/mL

Mean 2.76 2.75 −− 7.30 15.45 15.41
SD
CV
1 0.106
3.8
0.107
3.9
2 −−
−−
0.424
5.8
3 0.449
2.9
0.466
3.0
# Points 31 33 −− 2 31 33
# Labs 1 2 1 1 2

hGH Chemiluminescence ng/mL

Mean 2.20 2.24 6.41 6.44 12.68 12.73
SD
CV
1 0.503
22.8
0.511
22.9
2 1.40
21.8
1.44
22.3
3 2.83
22.3
3.06
24.0
# Points 256 813 278 863 259 730
# Labs 14 14 15 15 12 13
DiaSorin LIAISON/XL
Mean 2.68 2.68 7.49 7.49 15.00 15.00
SD
CV
1 0.115
4.3
0.115
4.3
2 0.289
3.9
0.289
3.9
3 1.15
7.7
1.15
7.7
# Points 3 3 3 3 3 3
# Labs 1 1 1 1 1 1
IDS iSYS
Mean 2.79 2.82 8.20 8.27 15.97 15.98
SD
CV
1 0.074
2.6
0.122
4.3
2 0.207
2.5
0.384
4.6
3 0.439
2.7
0.859
5.4
# Points 25 106 28 115 26 105
# Labs 1 2 1 2 1 2

Mean 3.09 3.13 8.27 8.46 15.73 15.84
SD
CV
1 0.218
7.0
0.212
6.8
2 0.677
8.2
0.626
7.4
3 1.07
6.8
1.07
6.8
# Points 254 1078 243 1030 149 696
# Labs 19 22 19 22 15 19

Mean 3.64 3.70 11.20 11.30 20.93 21.17
SD
CV
1 0.180
4.9
0.209
5.7
2 0.478
4.3
0.488
4.3
3 0.849
4.1
0.920
4.3
# Points 144 316 144 314 144 315
# Labs 6 6 7 7 7 7

Mean 2.86 2.88 8.13 8.09 15.65 15.52
SD
CV
1 0.644
22.5
0.618
21.5
2 2.04
25.0
1.85
22.9
3 3.76
24.0
3.56
22.9
# Points 713 2349 696 2327 612 1882
# Labs 42 47 43 48 37 44
hGH Chemiluminescence µIU/mL

Mean 8.27 8.25 −− 21.90 46.35 46.22
SD
CV
1 0.318
3.8
0.320
3.9
2 −−
−−
1.27
5.8
3 1.35
2.9
1.40
3.0
# Points 31 33 −− 2 31 33
# Labs 1 2 1 1 2

Mean 6.61 6.71 19.22 19.33 38.05 38.19
SD
CV
1 1.51
22.8
1.53
22.9
2 4.20
21.8
4.32
22.3
3 8.49
22.3
9.18
24.0
# Points 256 813 278 863 259 730
# Labs 14 14 15 15 12 13
DiaSorin LIAISON/XL
Mean 8.04 8.04 22.46 22.46 45.00 45.00
SD
CV
1 0.346
4.3
0.346
4.3
2 0.868
3.9
0.868
3.9
3 3.46
7.7
3.46
7.7
# Points 3 3 3 3 3 3
# Labs 1 1 1 1 1 1
IDS iSYS
Mean 8.38 8.47 24.59 24.81 47.91 47.95
SD
CV
1 0.221
2.6
0.365
4.3
2 0.622
2.5
1.15
4.6
3 1.32
2.7
2.58
5.4
# Points 25 106 28 115 26 105
# Labs 1 2 1 2 1 2

hGH Chemiluminescence µIU/mL

Mean 9.28 9.40 24.82 25.39 47.18 47.52
SD
CV
1 0.653
7.0
0.636
6.8
2 2.03
8.2
1.88
7.4
3 3.21
6.8
3.22
6.8
# Points 254 1078 243 1030 149 696
# Labs 19 22 19 22 15 19

Mean 10.93 11.10 33.61 33.90 62.79 63.52
SD
CV
1 0.539
4.9
0.627
5.7
2 1.43
4.3
1.46
4.3
3 2.55
4.1
2.76
4.3
# Points 144 316 144 314 144 315
# Labs 6 6 7 7 7 7

Mean 8.58 8.64 24.38 24.26 46.96 46.57
SD
CV
1 1.93
22.5
1.85
21.5
2 6.11
25.0
5.56
22.9
3 11.29
24.0
10.68
22.9
# Points 713 2349 696 2327 612 1882
# Labs 42 47 43 48 37 44
hGH EIA ng/mL

Tosoh AIA Models
Mean 3.07 3.04 8.48 8.37 16.06 16.32
SD
CV
1 0.000
0.0
0.117
3.8
2 0.000
0.0
0.253
3.0
3 0.000
0.0
0.415
2.5
# Points 1 6 1 6 1 6
# Labs 1 1 1 1 1 1

Mean 3.07 3.04 8.48 8.37 16.06 16.32
SD
CV
1 0.000
0.0
0.117
3.8
2 0.000
0.0
0.253
3.0
3 0.000
0.0
0.415
2.5
# Points 1 6 1 6 1 6
# Labs 1 1 1 1 1 1
hGH EIA µIU/mL

Tosoh AIA Models
Mean 9.21 9.13 25.44 25.11 48.18 48.97
SD
CV
1 0.000
0.0
0.350
3.8
2 0.000
0.0
0.759
3.0
3 0.000
0.0
1.25
2.5
# Points 1 6 1 6 1 6
# Labs 1 1 1 1 1 1

Mean 9.21 9.13 25.44 25.11 48.18 48.97
SD
CV
1 0.000
0.0
0.350
3.8
2 0.000
0.0
0.759
3.0
3 0.000
0.0
1.25
2.5
# Points 1 6 1 6 1 6
# Labs 1 1 1 1 1 1
hGH Electrochemiluminescence (ECL) ng/mL

Mean 3.12 3.13 8.05 8.09 15.64 15.57
SD
CV
1 0.125
4.0
0.107
3.4
2 0.288
3.6
0.311
3.8
3 0.559
3.6
0.558
3.6
# Points 78 295 99 449 100 443
# Labs 8 9 9 10 10 10

Mean 3.17 3.17 8.18 8.22 15.93 16.13
SD
CV
1 0.108
3.4
0.185
5.8
2 0.268
3.3
0.505
6.1
3 0.582
3.7
0.610
3.8
# Points 135 398 84 332 112 391
# Labs 5 7 4 6 5 5

hGH Electrochemiluminescence (ECL) ng/mL

Roche cobas u 601
Mean 3.05 3.03 7.97 7.88 15.42 15.25
SD
CV
1 0.050
1.6
0.064
2.1
2 0.160
2.0
0.205
2.6
3 0.220
1.4
0.352
2.3
# Points 7 14 7 14 7 14
# Labs 1 1 1 1 1 1

Mean 3.10 3.20 8.03 8.28 15.59 16.01
SD
CV
1 0.050
1.6
0.089
2.8
2 0.174
2.2
0.243
2.9
3 0.342
2.2
0.384
2.4
# Points 9 54 8 54 8 52
# Labs 2 2 2 2 2 2

Mean 3.14 3.15 8.10 8.15 15.78 15.83
SD
CV
1 0.115
3.7
0.154
4.9
2 0.279
3.4
0.402
4.9
3 0.577
3.7
0.638
4.0
# Points 229 761 198 849 227 900
# Labs 16 19 16 19 18 18
hGH Electrochemiluminescence (ECL) µIU/mL

Mean 9.35 9.39 24.15 24.27 46.93 46.70
SD
CV
1 0.375
4.0
0.322
3.4
2 0.863
3.6
0.934
3.8
3 1.68
3.6
1.67
3.6
# Points 78 295 99 449 100 443
# Labs 8 9 9 10 10 10

Mean 9.51 9.51 24.53 24.67 47.80 48.40
SD
CV
1 0.323
3.4
0.556
5.8
2 0.804
3.3
1.51
6.1
3 1.75
3.7
1.83
3.8
# Points 135 398 84 332 112 391
# Labs 5 7 4 6 5 5
Roche cobas u 601

Mean 9.15 9.10 23.91 23.63 46.26 45.76
SD
CV
1 0.150
1.6
0.191
2.1
2 0.480
2.0
0.615
2.6
3 0.660
1.4
1.06
2.3
# Points 7 14 7 14 7 14
# Labs 1 1 1 1 1 1

Mean 9.31 9.59 24.10 24.83 46.76 48.02
SD
CV
1 0.149
1.6
0.266
2.8
2 0.522
2.2
0.729
2.9
3 1.03
2.2
1.15
2.4
# Points 9 54 8 54 8 52
# Labs 2 2 2 2 2 2

Mean 9.43 9.46 24.30 24.46 47.33 47.50
SD
CV
1 0.345
3.7
0.463
4.9
2 0.836
3.4
1.21
4.9
3 1.73
3.7
1.91
4.0
# Points 229 761 198 849 227 900
# Labs 16 19 16 19 18 18
IgE Chemiluminescence IU/mL

Mean 370.2 381.0 −− 120.1 115.8 121.7
SD
CV
1 11.09
3.0
17.18
4.5
2 −−
−−
8.65
7.2
3 5.06
4.4
6.88
5.7
# Points 4 108 −− 63 4 62
# Labs 1 1 1 1 1

IgE Chemiluminescence IU/mL

Mean 338.0 324.4 82.54 85.47 98.23 93.65
SD
CV
1 36.06
10.7
42.36
13.1
2 13.89
16.8
13.16
15.4
3 16.62
16.9
14.59
15.6
# Points 27 39 20 40 10 32
# Labs 3 3 3 3 3 3
Siemens ADVIA Centaur CP • hCG, WHO 5th International Std 07/364

Mean 345.8 349.9 102.8 98.08 −− −−
SD
CV
1 27.93
8.1
27.84
8.0
2
10.41
10.1
10.09
10.3
3 −−
−−
−−
−−
# Points 18 54 12 41 −− −−
# Labs 1 1 1 1

Mean 364.1 361.4 103.1 101.9 106.8 105.0
SD
CV
1 25.29
6.9
23.63
6.5
2 6.36
6.2
5.98
5.9
3 6.12
5.7
5.92
5.6
# Points 792 2241 875 2212 713 1953
# Labs 34 39 33 37 34 38

Mean 378.5 375.7 104.7 103.6 109.4 108.2
SD
CV
1 15.34
4.1
16.40
4.4
2 4.51
4.3
4.60
4.4
3 4.36
4.0
4.72
4.4
# Points 148 221 183 260 131 204
# Labs 6 6 6 6 6 6

Mean 339.1 340.3 99.72 101.6 103.4 104.3
SD
CV
1 35.22
10.4
37.67
11.1
2 9.07
9.1
10.32
10.2
3 9.41
9.1
10.18
9.8
# Points 304 882 142 355 259 726
# Labs 12 13 10 11 10 11
Siemens IMMULITE 2000/2500/XPi • Siemens IMMULITE IgE, Rgt Lots 401+

Mean 352.3 349.8 102.5 101.9 112.4 112.4
SD
CV
1 35.46
10.1
33.66
9.6
2
13.98
13.6
12.88
12.6
3 16.51
14.7
16.51
14.7
# Points 37 48 39 50 12 12
# Labs 2 2 2 2 1 1

Mean 363.7 332.7 89.43 88.37 166.5 160.1
SD
CV
1 31.79
8.7
49.79
15.0
2 8.38
9.4
8.79
10.0
3 13.76
8.3
23.96
15.0
# Points 3 9 34 72 33 68
# Labs 1 2 2 3 2 3

Mean 359.1 357.0 102.2 101.8 108.0 106.5
SD
CV
1 30.33
8.4
30.09
8.4
2 7.87
7.7
7.95
7.8
3 12.61
11.7
11.77
11.1
# Points 1315 3548 1293 3052 1162 3057
# Labs 59 66 56 63 57 63
IgE EIA IU/mL

Tosoh AIA Models
Mean 313.1 311.6 94.61 93.98 97.98 97.82
SD
CV
1 9.36
3.0
8.15
2.6
2 2.92
3.1
2.38
2.5
3 3.03
3.1
2.80
2.9
# Points 22 65 22 66 22 66
# Labs 1 1 1 1 1 1

Mean 313.1 311.6 94.61 93.98 97.98 97.82
SD
CV
1 9.36
3.0
8.15
2.6
2 2.92
3.1
2.38
2.5
3 3.03
3.1
2.80
2.9
# Points 22 65 22 66 22 66
# Labs 1 1 1 1 1 1

IgE Electrochemiluminescence (ECL) IU/mL

Mean 359.4 358.6 116.0 114.9 118.9 117.7
SD
CV
1 18.79
5.2
18.34
5.1
2 6.48
5.6
6.24
5.4
3 6.23
5.2
5.97
5.1
# Points 495 1318 596 1783 503 1526
# Labs 30 34 32 39 30 34

Mean 335.7 336.2 105.1 105.0 120.7 115.0
SD
CV
1 32.07
9.6
41.11
12.2
2 15.55
14.8
18.16
17.3
3 4.23
3.5
17.66
15.4
# Points 686 2049 471 1463 217 614
# Labs 17 20 14 19 10 14
Roche cobas e 402/801 • Roche Elecsys IgE II, REF 07027516

Mean 365.5 367.3 116.1 116.8 116.3 117.8
SD
CV
1 13.28
3.6
12.77
3.5
2
2.92
2.5
2.84
2.4
3 2.87
2.5
2.88
2.4
# Points 14 17 50 105 36 88
# Labs 1 1 2 2 1 1

Mean 357.2 354.4 104.5 102.0 107.0 103.0
SD
CV
1 19.72
5.5
25.37
7.2
2 23.72
22.7
25.45
24.9
3 24.34
22.8
28.51
27.7
# Points 320 999 366 1156 290 840
# Labs 20 22 23 24 19 20

Mean 348.2 347.2 109.7 108.4 115.9 113.2
SD
CV
1 28.22
8.1
33.88
9.8
2 16.23
14.8
17.92
16.5
3 14.75
12.7
18.50
16.4
# Points 1515 4383 1483 4507 1046 3068
# Labs 68 77 71 84 60 69
IgE FIA IU/mL

Mean 314.0 287.8 82.93 81.31 102.6 87.28
SD
CV
1 0.000
0.0
22.89
8.0
2 19.16
23.1
8.43
10.4
3 4.54
4.4
9.24
10.6
# Points 1 36 2 41 3 41
# Labs 1 1 1 1 1 1
Phadia ImmunoCAP Series

Mean 349.8 344.2 115.2 112.7 118.3 115.8
SD
CV
1 24.44
7.0
22.56
6.6
2 7.76
6.7
7.38
6.6
3 7.61
6.4
8.01
6.9
# Points 18 36 18 36 18 36
# Labs 1 1 1 1 1 1

Mean 347.9 316.0 111.9 95.98 116.0 100.6
SD
CV
1 25.13
7.2
36.29
11.5
2 13.10
11.7
17.63
18.4
3 9.10
7.8
16.74
16.6
# Points 19 72 20 77 21 77
# Labs 2 2 2 2 2 2
IgE Immunoturbidimetric IU/mL

Mean 292.5 298.3 84.55 84.04 86.12 86.36
SD
CV
1 37.33
12.8
26.84
9.0
2 2.84
3.4
2.73
3.2
3 1.05
1.2
1.21
1.4
# Points 35 72 30 68 15 18
# Labs 2 2 2 2 1 1

IgE Immunoturbidimetric IU/mL

Mean 323.5 332.6 109.5 112.5 107.7 109.6
SD
CV
1 28.23
8.7
26.72
8.0
2 11.74
10.7
8.83
7.8
3 11.45
10.6
12.20
11.1
# Points 38 100 30 73 13 16
# Labs 2 2 2 2 1 1
Beckman Coulter AU Series • Biomed

Mean 343.0 342.7 103.3 102.6 106.4 103.7
SD
CV
1 6.48
1.9
5.90
1.7
2 8.43
8.2
7.14
7.0
3 5.04
4.7
7.24
7.0
# Points 11 15 11 19 11 15
# Labs 2 3 2 4 2 3
Beckman Coulter AU Series • Nucleus Diagnosys

Mean 407.4 406.1 119.5 118.1 −− −−
SD
CV
1 7.49
1.8
8.35
2.1
2 3.73
3.1
3.24
2.7
3 −−
−−
−−
−−
# Points 28 84 28 84 −− −−
# Labs 1 1 1 1
Roche cobas c 303/503 • Roche Elecsys IgE II, REF 07027516

Mean 392.4 384.7 125.9 122.9 128.0 125.7
SD
CV
1 5.65
1.4
8.87
2.3
2
2.27
1.8
3.88
3.2
3 2.01
1.6
2.88
2.3
# Points 22 48 22 48 21 47
# Labs 1 1 1 1 1 1

Mean 345.8 352.5 108.0 108.5 109.2 112.2
SD
CV
1 51.45
14.9
46.07
13.1
2 16.57
15.3
15.37
14.2
3 17.22
15.8
16.26
14.5
# Points 134 319 121 292 60 96
# Labs 8 9 8 10 5 6
Insulin Chemiluminescence µIU/mL

Abbott Alinity i
Mean 12.31 12.40 45.49 45.99 140.5 142.7
SD
CV
1 0.580
4.7
0.560
4.5
2 1.65
3.6
1.98
4.3
3 4.68
3.3
5.39
3.8
# Points 1445 3997 1348 3872 1199 3471
# Labs 28 31 25 30 25 28

Mean 13.63 13.65 47.52 47.77 145.5 146.1
SD
CV
1 0.432
3.2
0.438
3.2
2 1.32
2.8
1.59
3.3
3 4.75
3.3
5.41
3.7
# Points 430 1374 396 1276 211 777
# Labs 17 20 17 20 10 13

Mean 12.67 12.76 45.77 47.12 −− −−
SD
CV
1 0.442
3.5
0.471
3.7
2 1.76
3.8
2.07
4.4
3 −−
−−
−−
−−
# Points 23 75 25 78 −− −−
# Labs 1 1 1 1

Mean 20.65 18.89 76.43 67.46 −− 233.7
SD
CV
1 0.000
0.0
2.49
13.2
2 0.000
0.0
12.55
18.6
3 −−
−−
1.20
0.5
# Points 1 2 1 5 −− 2
# Labs 1 1 1 1 1

Mean 15.17 15.08 53.11 52.49 156.1 154.6
SD
CV
1 0.458
3.0
0.563
3.7
2 1.52
2.9
1.74
3.3
3 5.55
3.6
5.98
3.9
# Points 51 110 48 107 46 104
# Labs 3 3 3 3 3 3


Mean 14.91 15.11 52.59 53.37 157.5 160.3
SD
CV
1 0.863
5.8
0.880
5.8
2 2.95
5.6
3.23
6.1
3 10.13
6.4
12.23
7.6
# Points 557 2038 674 2318 614 1926
# Labs 29 31 32 34 31 32
DiaSorin LIAISON/XL
Mean 22.34 22.09 75.78 75.41 −− −−
SD
CV
1 0.660
3.0
0.780
3.5
2 1.60
2.1
2.62
3.5
3 −−
−−
−−
−−
# Points 5 8 5 8 −− −−
# Labs 1 1 1 1
Dirui CS Series
Mean −− 15.83 −− 62.09 −− −−
SD
CV
1 −−
−−
0.808
5.1
2 −−
−−
1.98
3.2
3 −−
−−
−−
−−
# Points −− 46 −− 48 −− −−
# Labs 1 1
Mindray CL Series
Mean 18.54 18.29 68.28 66.32 213.5 213.4
SD
CV
1 1.24
6.7
1.06
5.8
2 3.43
5.0
3.13
4.7
3 8.22
3.9
8.71
4.1
# Points 131 344 128 422 95 226
# Labs 6 8 6 9 5 6

Mean 14.18 14.18 55.00 55.00 −− −−
SD
CV
1 0.498
3.5
0.498
3.5
2 2.40
4.4
2.40
4.4
3 −−
−−
−−
−−
# Points 8 8 8 8 −− −−
# Labs 1 1 1 1

Mean 16.90 17.81 58.48 60.61 174.4 179.7
SD
CV
1 1.05
6.2
1.11
6.2
2 3.77
6.5
3.41
5.6
3 10.83
6.2
10.16
5.7
# Points 19 87 19 79 20 79
# Labs 3 3 3 3 3 3

Mean 18.24 18.40 63.22 63.55 184.7 184.4
SD
CV
1 1.14
6.2
1.27
6.9
2 4.25
6.7
4.23
6.7
3 13.87
7.5
12.53
6.8
# Points 261 983 259 1008 242 821
# Labs 13 15 13 15 13 13

Mean 17.78 17.93 59.13 59.55 176.5 175.5
SD
CV
1 0.834
4.7
0.810
4.5
2 2.20
3.7
2.28
3.8
3 7.36
4.2
6.63
3.8
# Points 171 546 157 403 137 303
# Labs 9 10 7 8 6 6

Mean −− 4.97 −− 16.13 −− 42.33
SD
CV
1 −−
−−
0.570
11.5
2 −−
−−
0.810
5.0
3 −−
−−
3.40
8.0
# Points −− 6 −− 6 −− 6
# Labs 1 1 1

Mean 13.39 13.57 56.76 57.52 169.3 169.5
SD
CV
1 0.887
6.6
1.03
7.6
2 3.49
6.1
4.22
7.3
3 3.79
2.2
8.87
5.2
# Points 14 23 17 34 3 11
# Labs 2 2 2 2 1 1


Snibe MAGLUMI Series • Snibe MAGLUMI Insulin REF 130X05002M
Mean −− 14.93 −− 59.57 −− 161.7
SD
CV
1 −−
−−
1.32
8.8
−−
−−
22.97
5.0
3 −−
−−
9.50
5.9
# Points −− 3 −− 3 −− 3
# Labs 1 1 1

Mean 15.40 15.47 57.96 57.67 175.5 174.7
SD
CV
1 0.956
6.2
0.859
5.6
2 3.38
5.8
3.10
5.4
3 11.09
6.3
9.41
5.4
# Points 890 4791 797 4489 834 4522
# Labs 39 42 36 40 37 39

Mean 14.40 14.75 52.25 53.54 159.6 162.8
SD
CV
1 2.16
15.0
2.05
13.9
2 7.19
13.8
6.84
12.8
3 20.47
12.8
18.94
11.6
# Points 4006 14441 3882 14164 3401 12251
# Labs 153 172 148 171 134 147
Insulin EIA µIU/mL

Roche cobas c 303/503 • Roche e 801 Insulin, REF 07027559
Mean 15.55 15.55 60.97 60.69 179.8 179.6
SD
CV
1 0.519
3.3
0.414
2.7
2
1.51
2.5
1.27
2.1
3 3.91
2.2
3.24
1.8
# Points 10 27 10 27 10 27
# Labs 1 1 1 1 1 1
Tosoh AIA Models

Mean −− 16.58 −− 59.93 −− 174.8
SD
CV
1 −−
−−
0.419
2.5
2 −−
−−
1.80
3.0
3 −−
−−
5.73
3.3
# Points −− 4 −− 4 −− 4
# Labs 1 1 1

Mean 15.55 15.68 60.97 60.59 179.8 179.0
SD
CV
1 0.519
3.3
0.537
3.4
2 1.51
2.5
1.34
2.2
3 3.91
2.2
3.88
2.2
# Points 10 31 10 31 10 31
# Labs 1 2 1 2 1 2
Insulin Electrochemiluminescence (ECL) µIU/mL

Mean −− 16.36 −− 61.06 −− 174.1
SD
CV
1 −−
−−
1.99
12.1
2 −−
−−
5.14
8.4
3 −−
−−
8.71
5.0
# Points −− 8 −− 8 −− 8
# Labs 1 1 1

Mean 16.23 16.33 63.06 62.97 182.7 182.1
SD
CV
1 0.989
6.1
1.05
6.5
2 3.85
6.1
4.21
6.7
3 10.38
5.7
12.17
6.7
# Points 604 1607 685 2201 583 2018
# Labs 34 36 38 40 33 35

Mean 16.20 16.39 63.66 64.44 182.3 183.1
SD
CV
1 0.680
4.2
0.763
4.7
2 2.28
3.6
2.89
4.5
3 7.98
4.4
9.19
5.0
# Points 899 2556 734 2119 299 754
# Labs 20 25 15 21 15 19

Insulin Electrochemiluminescence (ECL) µIU/mL

Roche cobas e 402/801 • Roche Elecsys Insulin, REF 07027559
Mean 15.55 15.47 61.10 60.47 179.6 176.9
SD
CV
1 0.385
2.5
0.396
2.6
1.48
2.4
2 1.37
2.3
3 5.30
2.9
4.42
2.5
# Points 19 87 17 86 10 64
# Labs 3 3 3 3 2 2
Roche cobas e 402/801 • Roche e 801 Insulin, REF 07027559

Mean 15.89 15.60 62.45 62.02 174.1 173.6
SD
CV
1 1.23
7.8
1.14
7.3
4.20
6.7
2 3.52
5.7
3 5.98
3.4
5.95
3.4
# Points 277 807 232 685 138 385
# Labs 9 9 8 8 5 5
Roche cobas u 601

Mean 16.74 16.69 63.91 64.13 186.7 186.8
SD
CV
1 0.540
3.2
0.610
3.7
2 3.85
6.0
2.99
4.7
3 8.67
4.6
7.51
4.0
# Points 10 22 10 21 10 21
# Labs 1 1 1 1 1 1

Mean 15.96 16.09 61.45 62.15 180.6 180.5
SD
CV
1 1.36
8.5
1.31
8.1
2 4.92
8.0
4.76
7.7
3 12.83
7.1
13.17
7.3
# Points 214 521 213 538 163 387
# Labs 16 18 16 17 13 14

Mean 15.74 16.15 58.96 59.84 180.5 182.1
SD
CV
1 0.733
4.7
0.802
5.0
2 2.52
4.3
2.22
3.7
3 5.68
3.1
7.52
4.1
# Points 55 239 70 257 51 229
# Labs 3 4 3 4 3 4
YHLO iFlash 3000

Mean −− −− 57.07 57.07 171.1 171.1
SD
CV
1 −−
−−
−−
−−
2 0.936
1.6
0.936
1.6
3 3.19
1.9
3.19
1.9
# Points −− −− 34 34 34 34
# Labs 1 1 1 1

Mean 16.13 16.22 62.78 63.11 181.1 181.1
SD
CV
1 0.958
5.9
1.00
6.2
2 3.68
5.9
3.86
6.1
3 10.00
5.5
11.22
6.2
# Points 2078 5847 1995 5949 1288 3900
# Labs 86 97 85 96 73 82
Insulin−like Growth Factor 1 (IGF−1, Somatomedin C) Chemiluminescence ng/mL

Mean 96.32 82.51 129.1 153.9 107.2 106.0
SD
CV
1 7.19
7.5
12.04
14.6
2 40.37
31.3
48.68
31.6
3 6.19
5.8
7.19
6.8
# Points 41 168 68 271 38 78
# Labs 4 4 6 6 4 4
LH Chemiluminescence mIU/mL
1drop
Mean 1.79 1.79 21.02 21.02 68.47 68.47
SD
CV
1 0.379
21.2
0.379
21.2
2 1.53
7.3
1.53
7.3
3 2.23
3.3
2.23
3.3
# Points 47 47 47 47 29 29
# Labs 2 2 2 2 1 1

Mean 1.12 1.12 14.73 14.71 48.31 48.13
SD
CV
1 0.057
5.1
0.063
5.6
2 0.518
3.5
0.563
3.8
3 1.76
3.6
1.80
3.7
# Points 1695 5378 1547 4936 1564 4861
# Labs 65 74 58 68 60 68
Abbott ARCHITECT/Alinity (c, i, ci models) • Abbott ARCHITECT LH (2P40)

Mean 1.18 1.19 15.13 15.24 48.41 49.77
SD
CV
1 0.052
4.4
0.054
4.5
2
0.653
4.3
0.756
5.0
3 3.60
7.4
3.09
6.2
# Points 282 742 279 595 194 617
# Labs 11 13 11 12 9 11
Abbott ARCHITECT/Alinity (c, i, ci models) • Abbott Alinity i LH, REF 07P91

Mean −− 1.20 −− 14.75 −− −−
SD
CV
1 −−
−−
0.066
5.5
2 −−
−−
0.202
1.4
3 −−
−−
−−
−−
# Points −− 27 −− 5 −− −−
# Labs 1 1

Mean 1.85 1.87 25.70 25.88 84.80 85.75
SD
CV
1 0.232
12.5
0.176
9.4
2 1.35
5.2
1.81
7.0
3 6.40
7.5
6.87
8.0
# Points 9 28 12 61 17 67
# Labs 2 2 2 4 3 4

Mean 1.31 1.31 18.24 18.16 57.70 57.85
SD
CV
1 0.082
6.3
0.100
7.6
2 1.04
5.7
1.08
6.0
3 3.78
6.5
4.39
7.6
# Points 123 522 119 542 111 537
# Labs 13 15 12 14 12 14

Mean 1.28 1.26 17.59 17.70 56.56 56.81
SD
CV
1 0.101
7.9
0.103
8.2
2 1.20
6.8
1.11
6.3
3 3.35
5.9
3.51
6.2
# Points 659 3114 720 2869 788 3262
# Labs 37 50 38 48 40 51
DiaSorin LIAISON/XL
Mean 2.05 2.05 26.61 26.61 −− −−
SD
CV
1 0.125
6.1
0.125
6.1
2 1.64
6.2
1.64
6.2
3 −−
−−
−−
−−
# Points 4 4 4 4 −− −−
# Labs 1 1 1 1
DiaSorin LIAISON/XL • DiaSorin LIAISON LH, REF 312201

Mean 1.85 1.94 23.45 24.30 −− −−
SD
CV
1 0.071
3.8
0.111
5.7
2.62
11.2
2 1.83
7.5
3 −−
−−
−−
−−
# Points 2 9 2 9 −− −−
# Labs 1 1 1 1
Dirui CS Series
Mean −− 1.39 −− 21.92 −− −−
SD
CV
1 −−
−−
0.063
4.6
2 −−
−−
0.861
3.9
3 −−
−−
−−
−−
# Points −− 29 −− 28 −− −−
# Labs 1 1
Mindray CL Series
Mean 1.92 1.93 22.62 22.34 74.53 74.53
SD
CV
1 0.066
3.4
0.070
3.6
2 1.06
4.7
0.920
4.1
3 0.000
0.0
0.000
0.0
# Points 33 43 46 194 1 1
# Labs 2 2 3 4 1 1

Mean 1.55 1.51 20.36 18.96 62.79 62.49
SD
CV
1 0.099
6.4
0.094
6.3
2 1.31
6.4
1.29
6.8
3 1.96
3.1
3.08
4.9
# Points 32 193 38 204 29 213
# Labs 3 4 4 5 3 7

Mean 1.42 1.39 18.47 18.39 60.33 60.51
SD
CV
1 0.124
8.7
0.127
9.1
2 1.03
5.6
1.00
5.4
3 3.01
5.0
3.41
5.6
# Points 596 2057 620 1944 528 1631
# Labs 29 34 28 32 28 31

Mean 1.37 1.40 18.22 18.72 59.15 62.30
SD
CV
1 0.060
4.4
0.081
5.8
2 0.680
3.7
0.864
4.6
3 2.08
3.5
4.62
7.4
# Points 31 66 31 66 31 66
# Labs 1 1 1 1 1 1

Mean 1.48 1.43 18.87 18.72 63.70 64.29
SD
CV
1 0.141
9.5
0.137
9.6
2 0.878
4.7
0.842
4.5
3 2.79
4.4
3.33
5.2
# Points 460 2205 479 2211 403 1866
# Labs 17 18 17 18 16 16

Mean 1.66 1.68 19.67 19.56 57.18 56.70
SD
CV
1 0.121
7.3
0.129
7.7
2 1.73
8.8
1.61
8.3
3 5.24
9.2
5.07
8.9
# Points 88 206 92 208 66 175
# Labs 6 6 6 6 5 5

Mean 2.31 2.63 26.56 26.08 77.87 75.44
SD
CV
1 0.236
10.2
2.10
80.1
2 1.01
3.8
1.64
6.3
3 2.24
2.9
9.50
12.6
# Points 24 37 34 54 26 37
# Labs 2 4 2 4 2 4
Tosoh AIA Models

Mean 1.21 1.23 17.31 18.10 61.78 63.22
SD
CV
1 0.106
8.8
0.093
7.5
2 1.16
6.7
1.24
6.8
3 3.54
5.7
3.30
5.2
# Points 22 185 22 186 22 186
# Labs 1 1 1 1 1 1

Mean 1.12 1.14 18.13 18.27 59.49 60.40
SD
CV
1 0.074
6.6
0.077
6.8
2 0.815
4.5
0.841
4.6
3 2.88
4.8
3.02
5.0
# Points 727 3316 678 3152 701 3203
# Labs 45 51 43 49 42 48

Mean 1.26 1.25 17.10 17.26 55.31 56.29
SD
CV
1 0.209
16.7
0.203
16.2
2 2.28
13.3
2.11
12.2
3 6.87
12.4
6.94
12.3
# Points 4834 18208 4770 17315 4510 16751
# Labs 238 281 230 272 224 263
LH EIA mIU/mL
Mean 1.92 1.92 21.58 21.58 65.50 65.50
SD
CV
1 0.060
3.1
0.060
3.1
2 1.66
7.7
1.66
7.7
3 2.24
3.4
2.24
3.4
# Points 17 17 18 18 19 19
# Labs 1 1 1 1 1 1

LH EIA mIU/mL
Tosoh AIA Models
Mean 1.30 1.24 18.70 18.48 65.24 63.00
SD
CV
1 0.038
2.9
0.078
6.3
2 0.376
2.0
0.409
2.2
3 1.41
2.2
2.75
4.4
# Points 22 125 22 75 22 126
# Labs 1 3 1 2 1 3

Mean 1.57 1.32 20.00 19.08 65.36 63.33
SD
CV
1 0.317
20.2
0.235
17.8
2 1.84
9.2
1.47
7.7
3 1.82
2.8
2.82
4.4
# Points 39 142 40 93 41 145
# Labs 2 4 2 3 2 4
LH Electrochemiluminescence (ECL) mIU/mL

1drop
Mean 2.09 2.09 22.36 22.36 69.38 69.38
SD
CV
1 0.078
3.7
0.078
3.7
2 0.508
2.3
0.508
2.3
3 3.51
5.1
3.51
5.1
# Points 28 28 28 28 28 28
# Labs 1 1 1 1 1 1

Mean 2.14 2.12 22.66 22.30 68.33 68.14
SD
CV
1 0.210
9.8
0.176
8.3
2 1.25
5.5
1.28
5.7
3 4.28
6.3
4.09
6.0
# Points 520 1450 615 1964 523 1729
# Labs 40 46 43 48 40 44
Roche cobas c 303/503 • Roche Elecsys LH, REF 07027575

Mean 2.17 2.16 22.67 22.77 69.92 70.31
SD
CV
1 0.038
1.8
0.060
2.8
2
0.476
2.1
0.617
2.7
3 1.50
2.1
1.34
1.9
# Points 27 58 27 59 27 58
# Labs 1 1 1 1 1 1

Mean 1.99 2.04 21.63 22.11 67.55 68.42
SD
CV
1 0.119
6.0
0.126
6.2
2 0.657
3.0
0.976
4.4
3 2.90
4.3
3.52
5.1
# Points 869 2655 613 2202 416 1460
# Labs 33 38 23 30 22 28
Roche cobas e 402/801 • Roche Elecsys LH, REF 07027575

Mean 2.06 2.06 22.11 22.27 67.68 68.32
SD
CV
1 0.079
3.9
0.085
4.1
2
0.558
2.5
0.718
3.2
3 2.05
3.0
2.28
3.3
# Points 41 120 44 125 29 75
# Labs 2 2 2 2 1 1
Mean 2.37 2.27 23.83 23.64 72.55 71.69
SD
CV
1 0.045
1.9
0.151
6.7
2
0.391
1.6
0.908
3.8
3 1.08
1.5
2.54
3.5
# Points 22 108 22 107 22 107
# Labs 1 1 1 1 1 1
Roche cobas u 601

Mean 2.11 2.09 22.68 22.28 69.04 68.10
SD
CV
1 0.090
4.3
0.077
3.7
2 0.660
2.9
0.637
2.9
3 1.93
2.8
1.70
2.5
# Points 8 16 8 17 8 17
# Labs 1 1 1 1 1 1

Mean 2.07 2.05 22.01 21.89 67.27 67.44
SD
CV
1 0.211
10.2
0.180
8.8
2 1.33
6.1
1.28
5.8
3 3.83
5.7
3.79
5.6
# Points 724 2413 779 2602 670 2241
# Labs 43 47 48 51 44 48

LH Electrochemiluminescence (ECL) mIU/mL

Mean 2.06 2.06 22.12 22.12 67.82 68.03
SD
CV
1 0.187
9.1
0.162
7.9
2 1.20
5.4
1.20
5.4
3 3.77
5.6
3.83
5.6
# Points 2239 6848 2136 7104 1723 5715
# Labs 122 137 120 135 111 125
LH FIA mIU/mL
Mean 1.37 1.39 16.53 16.47 58.95 58.68
SD
CV
1 0.102
7.4
0.098
7.1
2 0.733
4.4
0.877
5.3
3 2.43
4.1
3.26
5.6
# Points 58 246 61 251 61 252
# Labs 4 4 4 5 5 5

Mean 1.37 1.39 16.53 16.47 58.95 58.68
SD
CV
1 0.102
7.4
0.098
7.1
2 0.733
4.4
0.877
5.3
3 2.43
4.1
3.26
5.6
# Points 58 246 61 251 61 252
# Labs 4 4 4 5 5 5
LH FPIA mIU/mL
Mean 1.43 1.43 16.24 16.24 57.84 57.84
SD
CV
1 0.024
1.7
0.024
1.7
2 0.505
3.1
0.505
3.1
3 2.51
4.3
2.51
4.3
# Points 4 4 4 4 4 4
# Labs 1 1 1 1 1 1

Mean 1.43 1.43 16.24 16.24 57.84 57.84
SD
CV
1 0.024
1.7
0.024
1.7
2 0.505
3.1
0.505
3.1
3 2.51
4.3
2.51
4.3
# Points 4 4 4 4 4 4
# Labs 1 1 1 1 1 1
Lithium AAS (Atomic Absorption Spectroscopy) mEq/L

AAS, Flame
Mean 0.452 0.459 1.21 1.20 1.82 1.82
SD
CV
1 0.006
1.2
0.010
2.1
2 0.019
1.6
0.027
2.3
3 0.047
2.6
0.040
2.2
# Points 4 9 5 13 7 14
# Labs 1 1 1 1 1 1
Method Group • AAS (Atomic Absorption Spectroscopy)

Mean 0.452 0.459 1.21 1.20 1.82 1.82
SD
CV
1 0.006
1.2
0.010
2.1
2 0.019
1.6
0.027
2.3
3 0.047
2.6
0.040
2.2
# Points 4 9 5 13 7 14
# Labs 1 1 1 1 1 1
Lithium Colorimetric mEq/L

Mean 0.436 0.444 1.18 1.19 1.79 1.81
SD
CV
1 0.042
9.6
0.030
6.8
2 0.032
2.7
0.034
2.9
3 0.029
1.6
0.056
3.1
# Points 17 105 17 104 17 101
# Labs 2 3 2 3 2 3

Mean 0.438 0.427 1.18 1.19 1.77 1.77
SD
CV
1 0.032
7.2
0.033
7.8
2 0.023
1.9
0.025
2.1
3 0.052
3.0
0.053
3.0
# Points 99 356 59 132 101 358
# Labs 2 2 1 1 2 2

Lithium Colorimetric mEq/L

Mean 0.409 0.407 −− −− 1.98 1.89
SD
CV
1 0.037
9.0
0.034
8.4
2 −−
−−
−−
−−
3 0.026
1.3
0.076
4.0
# Points 7 26 −− −− 6 17
# Labs 1 1 1 1

Mean 0.715 0.743 1.60 1.60 2.42 2.42
SD
CV
1 0.039
5.4
0.047
6.3
2 0.041
2.6
0.041
2.6
3 0.079
3.3
0.067
2.8
# Points 15 32 12 12 15 32
# Labs 2 2 1 1 2 2
Method Group • Colorimetric

Mean 0.467 0.449 1.24 1.21 1.85 1.82
SD
CV
1 0.094
20.0
0.083
18.5
2 0.148
11.9
0.094
7.8
3 0.208
11.2
0.166
9.1
# Points 138 519 88 248 139 508
# Labs 7 8 4 5 7 8
Phenobarbital Chemiluminescence µg/mL

Mean 9.39 9.49 22.93 23.28 48.12 48.69
SD
CV
1 0.221
2.4
0.540
5.7
2 1.69
7.4
1.32
5.7
3 2.04
4.2
2.08
4.3
# Points 3 14 3 11 3 14
# Labs 2 2 2 2 2 2

Mean −− −− 24.82 24.90 52.49 52.36
SD
CV
1 −−
−−
−−
−−
2 1.27
5.1
1.46
5.8
3 3.29
6.3
3.58
6.8
# Points −− −− 14 25 14 26
# Labs 1 1 1 1

Mean 10.90 10.90 30.65 30.65 61.06 61.06
SD
CV
1 0.631
5.8
0.631
5.8
2 0.988
3.2
0.988
3.2
3 2.32
3.8
2.32
3.8
# Points 12 12 12 12 12 12
# Labs 1 1 1 1 1 1

Mean 10.60 10.15 27.04 25.96 55.59 53.38
SD
CV
1 0.843
8.0
0.917
9.0
2 3.35
12.4
3.10
11.9
3 5.57
10.0
5.38
10.1
# Points 15 26 29 48 29 52
# Labs 3 3 4 4 4 4
Phenobarbital EIA µg/mL

Mean 8.54 8.54 22.64 22.64 46.70 46.70
SD
CV
1 0.559
6.6
0.559
6.6
2 1.10
4.9
1.10
4.9
3 1.02
2.2
1.02
2.2
# Points 5 5 5 5 5 5
# Labs 1 1 1 1 1 1

Mean 8.74 8.80 22.65 22.67 45.60 46.13
SD
CV
1 0.366
4.2
0.365
4.2
2 0.794
3.5
0.832
3.7
3 2.90
6.4
3.01
6.5
# Points 101 330 73 182 100 324
# Labs 3 3 2 2 3 3

Phenobarbital EIA µg/mL

Beckman Coulter AU Series • Emit 2000 Phenobarbital, REF OSR4D229
Mean 9.14 9.14 −− −− 48.23 48.23
SD
CV
1 0.150
1.6
0.150
1.6
−−
−−
2 −−
−−
3 2.82
5.8
2.82
5.8
# Points 16 16 −− −− 16 16
# Labs 1 1 1 1

Mean 8.03 7.98 22.40 22.50 48.88 48.83
SD
CV
1 0.458
5.7
0.462
5.8
0.7932
3.5
0.723
3.2
3 1.43
2.9
1.29
2.7
# Points 31 61 32 61 32 61
# Labs 1 2 1 2 1 2

Mean 7.68 7.80 22.86 23.09 −− −−
SD
CV
1 0.348
4.5
0.397
5.1
0.5792
2.5
0.708
3.1
3 −−
−−
−−
−−
# Points 24 30 24 30 −− −−
# Labs 1 1 1 1

Mean 6.70 7.01 20.80 20.30 −− 45.42
SD
CV
1 0.100
1.5
0.409
5.8
2 0.000
0.0
1.03
5.1
3 −−
−−
1.32
2.9
# Points 2 22 1 17 −− 18
# Labs 1 1 1 1 1

Mean 8.48 8.55 22.61 22.54 46.60 46.57
SD
CV
1 0.607
7.2
0.625
7.3
2 0.791
3.5
0.993
4.4
3 2.96
6.4
2.93
6.3
# Points 179 464 135 295 153 424
# Labs 8 9 6 7 6 8
Phenobarbital FPIA µg/mL

Mean 8.32 8.30 23.32 23.32 −− −−
SD
CV
1 0.179
2.2
0.154
1.9
0.5902
2.5
0.569
2.4
3 −−
−−
−−
−−
# Points 64 131 160 313 −− −−
# Labs 2 2 2 2

Mean 8.32 8.30 23.32 23.32 −− −−
SD
CV
1 0.179
2.2
0.154
1.9
2 0.590
2.5
0.569
2.4
3 −−
−−
−−
−−
# Points 64 131 160 313 −− −−
# Labs 2 2 2 2
Phenobarbital Immunoturbidimetric µg/mL

Mean 9.50 9.50 24.10 24.10 49.96 49.96
SD
CV
1 0.353
3.7
0.353
3.7
2 1.01
4.2
1.01
4.2
3 2.58
5.2
2.58
5.2
# Points 21 21 21 21 21 21
# Labs 1 1 1 1 1 1

Mean 9.05 9.90 23.50 24.79 50.43 51.04
SD
CV
1 0.659
7.3
0.817
8.3
2 1.17
5.0
1.15
4.6
3 0.895
1.8
1.35
2.6
# Points 71 446 69 422 27 363
# Labs 2 2 2 2 1 2

Phenobarbital Immunoturbidimetric µg/mL

Mean 9.16 9.88 23.64 24.75 50.23 50.99
SD
CV
1 0.630
6.9
0.806
8.2
2 1.15
4.9
1.15
4.6
3 1.83
3.6
1.46
2.9
# Points 92 467 90 443 48 384
# Labs 3 3 3 3 2 3
Phenobarbital KIMS (Roche) µg/mL

Mean 9.28 9.28 24.21 23.70 50.43 48.92
SD
CV
1 0.604
6.5
0.661
7.1
2 1.07
4.4
1.21
5.1
3 1.87
3.7
2.20
4.5
# Points 188 1412 187 1416 187 1404
# Labs 5 6 5 6 5 6

Mean 9.57 9.47 −− 24.74 51.39 49.97
SD
CV
1 0.296
3.1
0.461
4.9
2 −−
−−
1.02
4.1
3 1.47
2.9
2.01
4.0
# Points 32 114 −− 56 32 114
# Labs 1 2 1 1 2

Mean 9.33 9.30 24.21 23.74 50.57 49.00
SD
CV
1 0.578
6.2
0.650
7.0
2 1.07
4.4
1.21
5.1
3 1.85
3.7
2.20
4.5
# Points 220 1526 187 1472 219 1518
# Labs 6 8 5 7 6 8
Phenytoin (Dilantin) Chemiluminescence µg/mL

Mean 6.33 6.31 12.97 12.98 24.23 24.30
SD
CV
1 0.231
3.6
0.240
3.8
2 0.438
3.4
0.575
4.4
3 1.10
4.5
1.07
4.4
# Points 88 399 40 226 88 384
# Labs 6 6 2 5 5 7

Mean 6.34 6.33 13.02 13.08 24.22 24.27
SD
CV
1 0.203
3.2
0.303
4.8
2
0.337
2.6
0.599
4.6
3 1.11
4.6
1.10
4.5
# Points 13 81 13 74 13 88
# Labs 1 1 1 1 1 1

Mean −− 6.59 −− 13.79 −− 29.14
SD
CV
1 −−
−−
0.253
3.8
2 −−
−−
0.700
5.1
3 −−
−−
1.05
3.6
# Points −− 6 −− 6 −− 5
# Labs 1 1 1

Mean 7.38 7.14 13.19 13.55 24.14 24.27
SD
CV
1 0.641
8.7
0.683
9.6
2 1.43
10.8
1.56
11.5
3 2.26
9.4
2.15
8.9
# Points 24 59 11 30 26 74
# Labs 3 3 2 2 3 3
Mean −− 6.69 −− 13.44 −− 24.86
SD
CV
1 −−
−−
0.768
11.5
2 −−
−−
1.96
14.6
3 −−
−−
3.26
13.1
# Points −− 7 −− 9 −− 5
# Labs 1 1 1

Phenytoin (Dilantin) Chemiluminescence µg/mL

Mean −− 6.29 −− 12.77 −− 24.54
SD
CV
1 −−
−−
0.128
2.0
2 −−
−−
0.369
2.9
3 −−
−−
1.19
4.9
# Points −− 20 −− 21 −− 21
# Labs 1 1 1

Mean 5.35 5.66 11.95 11.93 23.14 22.69
SD
CV
1 0.120
2.2
0.323
5.7
2 0.530
4.4
0.366
3.1
3 0.840
3.6
0.988
4.4
# Points 16 90 16 88 19 91
# Labs 1 1 1 1 1 1

Mean 5.15 5.15 11.77 11.77 22.64 22.64
SD
CV
1 0.140
2.7
0.140
2.7
2 0.670
5.7
0.670
5.7
3 0.430
1.9
0.430
1.9
# Points 4 4 3 3 2 2
# Labs 1 1 1 1 1 1

Mean 6.36 6.29 12.72 12.79 24.04 24.09
SD
CV
1 0.685
10.8
0.505
8.0
2 0.853
6.7
0.882
6.9
3 1.41
5.9
1.48
6.2
# Points 132 585 70 383 135 582
# Labs 11 14 6 12 10 15
Phenytoin (Dilantin) EIA µg/mL

Mean 6.66 6.75 13.74 14.29 25.73 25.74
SD
CV
1 0.478
7.2
0.533
7.9
2 0.764
5.6
0.840
5.9
3 1.40
5.5
1.49
5.8
# Points 35 204 35 204 35 205
# Labs 3 3 3 3 3 3

Mean 6.19 6.06 12.77 12.95 23.60 23.66
SD
CV
1 0.433
7.0
0.492
8.1
2 0.653
5.1
0.793
6.1
3 1.98
8.4
2.20
9.3
# Points 102 323 72 177 99 326
# Labs 3 3 2 2 3 3
Beckman Coulter AU Series • Emit 2000 Phenytoin, REF OSR4A229

Mean 6.12 6.12 −− −− 23.93 23.93
SD
CV
1 0.364
6.0
0.364
6.0
−−
−−
2 −−
−−
3 2.58
10.8
2.58
10.8
# Points 44 44 −− −− 48 48
# Labs 2 2 2 2

Mean 5.81 5.88 12.73 12.81 24.36 24.34
SD
CV
1 0.339
5.8
0.407
6.9
0.3952
3.1
0.644
5.0
3 0.705
2.9
0.795
3.3
# Points 30 62 30 62 30 62
# Labs 1 2 1 2 1 2

Mean 4.90 5.01 9.80 9.69 18.00 18.88
SD
CV
1 0.300
6.1
0.517
10.3
2 0.500
5.1
0.752
7.8
3 0.700
3.9
2.40
12.7
# Points 5 48 9 58 8 52
# Labs 1 1 1 1 1 1

Mean 6.23 6.18 −− 12.62 24.26 24.13
SD
CV
1 0.225
3.6
0.199
3.2
2 −−
−−
0.534
4.2
3 0.941
3.9
0.986
4.1
# Points 12 111 −− 96 12 110
# Labs 1 4 3 1 4

Phenytoin (Dilantin) EIA µg/mL

Mean −− 6.08 −− 12.29 −− 22.94
SD
CV
1 −−
−−
0.253
4.2
2 −−
−−
0.809
6.6
3 −−
−−
1.62
7.1
# Points −− 73 −− 59 −− 73
# Labs 5 3 5

Mean 5.48 5.79 12.07 12.07 22.43 22.23
SD
CV
1 0.292
5.3
0.375
6.5
2 0.447
3.7
0.447
3.7
3 0.905
4.0
0.913
4.1
# Points 5 14 4 4 5 14
# Labs 3 4 2 2 3 4

Mean 6.16 6.16 12.79 12.95 23.90 23.90
SD
CV
1 0.508
8.3
0.603
9.8
2 1.07
8.4
1.46
11.2
3 2.27
9.5
2.40
10.0
# Points 233 879 150 660 237 890
# Labs 14 24 9 16 14 24
Phenytoin (Dilantin) Immunoturbidimetric µg/mL

Mean 6.64 6.64 13.93 13.93 25.04 25.04
SD
CV
1 0.080
1.2
0.080
1.2
2 0.174
1.3
0.174
1.3
3 0.266
1.1
0.266
1.1
# Points 5 5 5 5 5 5
# Labs 1 1 1 1 1 1

Mean 6.22 6.22 13.54 13.54 27.36 27.36
SD
CV
1 0.545
8.8
0.545
8.8
2 0.340
2.5
0.340
2.5
3 0.461
1.7
0.461
1.7
# Points 21 21 21 21 21 21
# Labs 1 1 1 1 1 1

Mean 6.60 6.70 13.71 13.87 26.27 26.33
SD
CV
1 0.415
6.3
0.346
5.2
2 0.510
3.7
0.601
4.3
3 0.934
3.6
0.838
3.2
# Points 75 452 75 433 73 415
# Labs 3 3 3 3 3 3

Mean 5.19 5.24 −− −− 23.08 22.15
SD
CV
1 0.704
13.6
0.852
16.3
2 −−
−−
−−
−−
3 2.22
9.6
2.02
9.1
# Points 34 89 −− −− 34 82
# Labs 2 2 2 2

Mean 6.19 6.45 13.69 13.85 25.58 25.70
SD
CV
1 0.787
12.7
0.708
11.0
2 0.474
3.5
0.592
4.3
3 2.03
7.9
1.90
7.4
# Points 135 567 101 459 133 523
# Labs 7 7 5 5 7 7
Phenytoin (Dilantin) KIMS (Roche) µg/mL

Mean 6.22 6.12 12.57 12.54 24.37 23.98
SD
CV
1 0.413
6.6
0.402
6.6
2 0.643
5.1
0.651
5.2
3 1.35
5.6
1.17
4.9
# Points 193 1548 195 1549 194 1548
# Labs 6 8 6 8 6 8

Phenytoin (Dilantin) KIMS (Roche) µg/mL

Mean 7.34 7.11 −− 13.58 26.97 26.33
SD
CV
1 0.368
5.0
0.420
5.9
2 −−
−−
0.657
4.8
3 1.23
4.6
1.38
5.2
# Points 72 171 −− 46 72 172
# Labs 2 3 1 2 3

Mean 6.52 6.22 12.57 12.57 25.07 24.22
SD
CV
1 0.641
9.8
0.501
8.0
2 0.643
5.1
0.674
5.4
3 1.75
7.0
1.39
5.7
# Points 265 1719 195 1595 266 1720
# Labs 8 11 6 9 8 11
Progesterone Chemiluminescence ng/mL

1drop
Mean 0.726 0.706 11.25 11.01 27.11 26.68
SD
CV
1 0.068
9.4
0.069
9.8
2 0.881
7.8
0.763
6.9
3 0.787
2.9
1.03
3.9
# Points 88 149 87 148 78 139
# Labs 4 4 4 4 3 3
Abbott Alinity i
Mean 0.561 0.562 8.25 8.39 22.40 23.03
SD
CV
1 0.049
8.8
0.051
9.0
2 0.351
4.3
0.383
4.6
3 1.06
4.7
1.16
5.0
# Points 1409 4295 1354 4331 1382 4169
# Labs 38 42 33 38 38 41

Mean 0.605 0.614 9.14 9.16 25.17 25.91
SD
CV
1 0.046
7.6
0.053
8.7
2 0.405
4.4
0.443
4.8
3 1.50
6.0
1.71
6.6
# Points 467 1683 317 969 339 1267
# Labs 20 25 14 17 17 18
Abbott ARCHITECT (c, i, ci models) • Alternate Formulation/Standardization

Mean 0.540 0.540 −− −− 23.27 23.27
SD
CV
1 0.000
0.0
0.000
0.0
−−
−−
2 −−
−−
3 0.127
0.5
0.127
0.5
# Points 2 2 −− −− 2 2
# Labs 1 1 1 1

Mean 0.550 0.583 8.36 8.63 −− −−
SD
CV
1 0.051
9.3
0.056
9.6
2 0.271
3.2
0.403
4.7
3 −−
−−
−−
−−
# Points 28 82 26 80 −− −−
# Labs 1 1 1 1

Mean 0.269 0.116 1.05 1.69 0.382 0.372
SD
CV
1 0.387
143.8
0.276
237.7
2 3.01
285.3
4.15
245.1
3 0.012
3.1
0.022
5.9
# Points 12 29 11 31 13 31
# Labs 2 2 2 2 1 1

Mean 0.618 0.620 9.81 9.78 24.64 24.39
SD
CV
1 0.133
21.6
0.119
19.2
2 0.746
7.6
0.763
7.8
3 2.01
8.1
1.77
7.2
# Points 105 436 90 410 98 423
# Labs 12 14 8 12 10 12

Mean 0.603 0.595 9.90 9.86 25.20 25.45
SD
CV
1 0.114
19.0
0.115
19.4
2 0.933
9.4
0.901
9.1
3 2.20
8.7
2.12
8.4
# Points 596 2481 654 2389 692 2501
# Labs 38 47 38 47 38 46


DiaSorin LIAISON/XL
Mean 0.631 0.589 −− 9.94 20.68 20.68
SD
CV
1 0.078
12.3
0.052
8.9
2 −−
−−
0.698
7.0
3 1.21
5.9
1.21
5.9
# Points 4 21 −− 18 4 4
# Labs 1 2 1 1 1
Dirui CS Series
Mean −− 0.458 −− 9.54 −− −−
SD
CV
1 −−
−−
0.023
5.0
2 −−
−−
0.312
3.3
3 −−
−−
−−
−−
# Points −− 55 −− 55 −− −−
# Labs 1 1
Mindray CL Series
Mean 0.654 0.653 12.14 8.58 36.22 36.13
SD
CV
1 0.055
8.5
0.051
7.8
2 0.592
4.9
4.10
47.8
3 2.49
6.9
2.13
5.9
# Points 46 64 58 212 16 24
# Labs 3 3 4 5 3 3

Mean 0.812 0.795 8.72 8.72 19.78 20.11
SD
CV
1 0.087
10.7
0.086
10.8
2 0.314
3.6
0.450
5.2
3 0.828
4.2
1.06
5.3
# Points 39 293 39 270 38 262
# Labs 2 2 2 3 2 4

Mean 0.756 0.782 8.49 8.86 19.13 19.88
SD
CV
1 0.122
16.1
0.123
15.7
2 0.770
9.1
0.755
8.5
3 1.69
8.9
1.43
7.2
# Points 124 429 119 407 116 406
# Labs 10 11 10 12 10 11

Mean 0.780 0.705 8.54 8.26 19.82 19.03
SD
CV
1 0.080
10.3
0.119
17.0
2 0.440
5.2
0.490
5.9
3 0.840
4.2
1.21
6.4
# Points 31 67 31 66 31 67
# Labs 1 1 1 1 1 1

Mean 0.754 0.776 9.12 9.17 20.88 20.86
SD
CV
1 0.081
10.7
0.087
11.2
2 0.427
4.7
0.427
4.7
3 0.931
4.5
0.916
4.4
# Points 322 2000 327 1979 320 1874
# Labs 11 12 11 12 11 11

Mean 0.703 0.687 8.34 8.23 20.01 19.95
SD
CV
1 0.082
11.6
0.093
13.5
2 0.453
5.4
0.563
6.8
3 1.39
7.0
1.60
8.0
# Points 112 250 116 264 40 133
# Labs 5 5 5 5 3 3

Mean 0.510 1.15 10.22 10.78 19.95 21.31
SD
CV
1 0.094
18.5
3.56
308.5
2 0.849
8.3
3.10
28.7
3 2.39
12.0
4.25
19.9
# Points 24 30 30 44 22 31
# Labs 2 3 2 3 2 3
Tosoh AIA Models

Mean 0.642 0.564 13.67 13.00 33.27 32.05
SD
CV
1 0.038
6.0
0.057
10.1
2 0.848
6.2
0.557
4.3
3 1.05
3.1
1.20
3.8
# Points 24 200 24 200 24 200
# Labs 1 1 1 1 1 1


Mean 0.570 0.627 9.56 9.99 27.32 28.24
SD
CV
1 0.058
10.2
0.117
18.6
2 0.516
5.4
1.26
12.6
3 1.38
5.0
3.43
12.2
# Points 556 2401 534 2310 519 2201
# Labs 32 37 29 35 30 33

Mean 0.609 0.630 9.08 9.21 23.74 24.25
SD
CV
1 0.105
17.2
0.199
31.5
2 1.17
12.9
1.28
13.9
3 3.24
13.6
3.55
14.6
# Points 3987 14965 3817 14183 3732 13732
# Labs 183 213 165 200 171 192
Progesterone EIA ng/mL

Mean 0.888 0.888 11.33 11.33 30.69 30.69
SD
CV
1 0.153
17.2
0.153
17.2
2 0.240
2.1
0.240
2.1
3 1.42
4.6
1.42
4.6
# Points 5 5 5 5 5 5
# Labs 1 1 1 1 1 1
Tosoh AIA Models • Tosoh AIA PROG III (Cat. No. 025240)
Mean −− 0.591 −− 13.49 −− 31.26
SD
CV
1 −−
−−
0.103
17.5
2 −−
−−
0.188
1.4
3 −−
−−
1.85
5.9
# Points −− 135 −− 16 −− 135
# Labs 2 1 2

Mean 0.888 0.601 11.33 12.98 30.69 31.24
SD
CV
1 0.153
17.2
0.119
19.7
2 0.240
2.1
0.963
7.4
3 1.42
4.6
1.84
5.9
# Points 5 140 5 21 5 140
# Labs 1 3 1 2 1 3
Progesterone Electrochemiluminescence (ECL) ng/mL

Mean 0.430 0.380 7.54 7.48 23.22 22.82
SD
CV
1 0.000
0.0
0.071
18.6
2 1.58
20.9
0.989
13.2
3 3.65
15.7
2.86
12.5
# Points 1 2 3 12 3 12
# Labs 1 1 1 1 1 1

Mean 0.704 0.698 11.02 10.99 27.21 27.33
SD
CV
1 0.119
16.9
0.102
14.6
2 0.616
5.6
0.599
5.4
3 1.35
5.0
1.35
4.9
# Points 271 756 371 1049 330 974
# Labs 19 20 20 21 19 19

Mean 0.810 0.810 −− −− 28.56 28.56
SD
CV
1 0.048
5.9
0.048
5.9
2 −−
−−
−−
−−
3 0.806
2.8
0.806
2.8
# Points 21 21 −− −− 21 21
# Labs 1 1 1 1
Roche cobas 6000/8000/c 311 • Roche Elecsys Progesterone III REF 07027699
Mean 0.685 0.681 11.03 11.02 26.90 26.92
SD
CV
1 0.055
8.0
0.054
8.0
0.319
2.9
2 0.306
2.8
3 0.745
2.8
0.713
2.7
# Points 11 12 11 12 11 12
# Labs 1 1 1 1 1 1

Progesterone Electrochemiluminescence (ECL) ng/mL

Roche cobas 6000/8000/c 311 • Roche Progesterone III, Ref 07092539190
Mean 0.769 0.744 10.87 10.59 26.28 26.65
SD
CV
1 0.134
17.5
0.216
29.1
2
0.534
4.9
0.589
5.6
3 3.12
11.9
6.79
25.5
# Points 351 1619 396 1816 330 1741
# Labs 13 14 14 14 14 15
Roche cobas c 303/503 • Roche Elecsys Progesterone III REF 07027699

Mean 0.722 0.715 10.91 10.87 26.94 26.81
SD
CV
1 0.027
3.7
0.032
4.4
2
0.166
1.5
0.184
1.7
3 0.383
1.4
0.437
1.6
# Points 27 60 27 60 27 60
# Labs 1 1 1 1 1 1

Mean 0.696 0.699 10.79 10.66 26.95 26.64
SD
CV
1 0.097
14.0
0.113
16.1
2 0.459
4.3
1.83
17.2
3 1.02
3.8
3.95
14.8
# Points 232 623 169 506 216 633
# Labs 12 15 10 12 12 15
Roche cobas e 402/801 • Roche Elecsys Progesterone III REF 07027699

Mean 0.718 0.717 11.12 11.09 26.68 26.63
SD
CV
1 0.082
11.4
0.106
14.8
2
0.444
4.0
0.555
5.0
3 0.785
2.9
0.835
3.1
# Points 624 2140 463 1577 268 884
# Labs 19 19 14 14 11 11
Roche cobas u 601

Mean 0.780 0.780 10.93 10.95 26.49 26.14
SD
CV
1 0.050
6.4
0.043
5.6
2 0.380
3.5
0.274
2.5
3 0.800
3.0
0.809
3.1
# Points 6 13 6 13 5 12
# Labs 1 1 1 1 1 1

Mean 0.734 0.703 10.90 10.86 27.10 26.37
SD
CV
1 0.105
14.4
0.155
22.1
2 0.597
5.5
0.650
6.0
3 1.53
5.6
4.90
18.6
# Points 312 912 319 911 270 708
# Labs 27 30 26 29 21 25
Roche Elecsys / cobas e 411 Series • 10 mL vial

Mean 0.744 0.764 11.21 11.10 27.39 27.45
SD
CV
1 0.050
6.8
0.069
9.1
2 0.375
3.3
0.418
3.8
3 0.602
2.2
0.845
3.1
# Points 18 58 18 59 17 51
# Labs 1 1 1 1 1 1
Roche Elecsys / cobas e 411 Series • 3rd Generation

Mean −− 0.616 −− 10.39 −− 26.07
SD
CV
1 −−
−−
0.052
8.4
2 −−
−−
0.296
2.9
3 −−
−−
0.673
2.6
# Points −− 44 −− 42 −− 42
# Labs 1 1 1
Roche Elecsys / cobas e 411 Series • Roche Progesterone III, Ref 07092539190
Mean 0.693 0.676 10.70 10.61 26.65 26.32
SD
CV
1 0.075
10.8
0.068
10.0
2
0.318
3.0
0.301
2.8
3 0.788
3.0
0.850
3.2
# Points 171 708 148 619 140 670
# Labs 8 8 7 7 6 7

Mean 0.724 0.713 10.94 10.82 26.84 26.69
SD
CV
1 0.105
14.5
0.144
20.2
2 0.551
5.0
0.783
7.2
3 1.79
6.7
4.37
16.4
# Points 2045 6968 1931 6676 1638 5820
# Labs 104 113 96 103 89 99

Progesterone FIA ng/mL

Mean 0.579 0.598 11.69 11.56 33.37 32.57
SD
CV
1 0.152
26.3
0.135
22.6
2 0.822
7.0
0.835
7.2
3 1.70
5.1
2.23
6.8
# Points 37 190 35 181 34 186
# Labs 2 2 2 2 2 2

Mean 0.579 0.598 11.69 11.56 33.37 32.57
SD
CV
1 0.152
26.3
0.135
22.6
2 0.822
7.0
0.835
7.2
3 1.70
5.1
2.23
6.8
# Points 37 190 35 181 34 186
# Labs 2 2 2 2 2 2
Prolactin Chemiluminescence ng/mL

1drop
Mean 1.17 1.17 6.60 6.60 −− −−
SD
CV
1 0.058
4.9
0.058
4.9
2 0.200
3.0
0.200
3.0
3 −−
−−
−−
−−
# Points 3 3 3 3 −− −−
# Labs 1 1 1 1
Abbott Alinity i
Mean 7.16 7.18 20.73 20.87 44.65 44.93
SD
CV
1 0.294
4.1
0.306
4.3
2 0.775
3.7
0.851
4.1
3 1.96
4.4
2.00
4.5
# Points 1255 3718 1186 3602 1184 3494
# Labs 44 50 42 49 44 49

Mean 6.85 6.89 20.13 20.20 43.49 43.58
SD
CV
1 0.368
5.4
0.346
5.0
2 1.03
5.1
1.02
5.0
3 2.69
6.2
2.44
5.6
# Points 568 1716 489 1358 394 1224
# Labs 26 33 24 31 21 25

Mean 7.57 7.56 22.20 21.97 −− −−
SD
CV
1 0.270
3.6
0.235
3.1
2 0.953
4.3
0.807
3.7
3 −−
−−
−−
−−
# Points 27 82 28 82 −− −−
# Labs 1 1 1 1

Mean 10.57 10.67 27.25 27.81 62.98 65.66
SD
CV
1 0.547
5.2
0.872
8.2
2 1.65
6.1
1.90
6.8
3 3.83
6.1
4.37
6.7
# Points 12 32 14 57 21 65
# Labs 2 2 3 3 3 3

Mean 6.80 6.65 18.06 18.26 41.79 41.13
SD
CV
1 0.421
6.2
0.473
7.1
2 0.993
5.5
1.19
6.5
3 2.66
6.4
2.87
7.0
# Points 163 552 154 517 140 491
# Labs 14 16 13 15 12 14

Mean 6.19 6.05 16.46 16.74 37.83 37.60
SD
CV
1 0.554
8.9
0.523
8.6
2 0.998
6.1
1.04
6.2
3 2.90
7.7
3.02
8.0
# Points 812 3475 858 3166 901 3517
# Labs 46 56 44 54 48 57
DiaSorin LIAISON/XL • DiaSorin LIAISON Prolactin xt, REF 312171

Mean 5.24 7.31 16.11 20.04 −− −−
SD
CV
1 0.387
7.4
1.76
24.1
1.49
9.2
2 3.60
18.0
3 −−
−−
−−
−−
# Points 4 11 4 11 −− −−
# Labs 1 1 1 1


Dirui CS Series
Mean −− 287.1 −− 1314 −− −−
SD
CV
1 −−
−−
9.51
3.3
2 −−
−−
41.47
3.2
3 −−
−−
−−
−−
# Points −− 57 −− 57 −− −−
# Labs 1 1
Mindray CL Series
Mean 8.92 8.83 309.4 299.7 55.09 55.09
SD
CV
1 0.266
3.0
0.302
3.4
2 471.9
152.5
471.1
157.2
3 1.80
3.3
1.80
3.3
# Points 35 45 44 191 3 3
# Labs 2 2 3 4 1 1

Mean 8.86 9.02 24.35 24.18 −− −−
SD
CV
1 0.309
3.5
0.373
4.1
2 1.09
4.5
1.09
4.5
3 −−
−−
−−
−−
# Points 8 24 8 24 −− −−
# Labs 1 1 1 1

Mean 5.43 5.45 14.56 14.52 32.57 32.63
SD
CV
1 0.283
5.2
0.307
5.6
2 1.05
7.2
0.959
6.6
3 2.60
8.0
2.50
7.7
# Points 42 119 47 116 27 98
# Labs 4 4 6 6 6 7

Mean 5.35 5.44 14.68 14.58 32.40 32.14
SD
CV
1 0.264
4.9
0.285
5.2
2 0.745
5.1
0.756
5.2
3 2.06
6.4
2.05
6.4
# Points 509 1866 530 1751 440 1384
# Labs 29 36 27 31 28 31

Mean 5.25 5.25 13.77 13.77 −− −−
SD
CV
1 0.217
4.1
0.217
4.1
2 0.527
3.8
0.527
3.8
3 −−
−−
−−
−−
# Points 8 8 8 8 −− −−
# Labs 1 1 1 1

Mean 5.31 5.28 14.26 14.18 31.44 31.63
SD
CV
1 0.220
4.1
0.213
4.0
2 0.571
4.0
0.597
4.2
3 1.33
4.2
1.52
4.8
# Points 456 2299 464 2309 416 2001
# Labs 18 19 18 19 17 17

Mean 7.20 7.02 18.96 18.61 44.12 43.07
SD
CV
1 0.466
6.5
0.434
6.2
2 1.09
5.8
1.04
5.6
3 2.81
6.4
2.45
5.7
# Points 86 204 89 208 60 167
# Labs 6 6 6 6 5 5

Mean 5.58 4.64 14.74 11.69 50.36 37.48
SD
CV
1 3.20
57.4
3.56
76.9
2 10.14
68.8
10.57
90.4
3 2.72
5.4
21.65
57.8
# Points 23 35 29 47 18 30
# Labs 2 4 2 4 1 3
Tosoh AIA Models

Mean 1.27 1.26 7.00 6.91 7.65 7.57
SD
CV
1 0.050
3.9
0.076
6.0
2 0.283
4.0
0.269
3.9
3 0.311
4.1
0.901
11.9
# Points 4 19 4 19 4 19
# Labs 1 1 1 1 1 1


Mean 7.47 7.48 16.87 16.82 34.38 34.49
SD
CV
1 0.350
4.7
0.349
4.7
2 0.731
4.3
0.728
4.3
3 1.75
5.1
1.80
5.2
# Points 665 2877 608 2578 645 2781
# Labs 42 46 39 43 39 44

Mean 6.60 7.43 20.54 25.42 38.89 38.14
SD
CV
1 0.956
14.5
16.19
217.9
2 54.01
262.9
97.27
382.7
3 5.90
15.2
5.96
15.6
# Points 4680 17142 4567 16104 4253 15274
# Labs 241 281 233 272 226 257
Prolactin Chemiluminescence µIU/mL

1drop
Mean 24.73 24.73 139.9 139.9 −− −−
SD
CV
1 1.22
4.9
1.22
4.9
2 4.24
3.0
4.24
3.0
3 −−
−−
−−
−−
# Points 3 3 3 3 −− −−
# Labs 1 1 1 1
Abbott Alinity i
Mean 151.9 152.2 439.5 442.5 946.6 952.5
SD
CV
1 6.23
4.1
6.48
4.3
2 16.43
3.7
18.05
4.1
3 41.50
4.4
42.50
4.5
# Points 1255 3718 1186 3602 1184 3494
# Labs 44 50 42 49 44 49

Mean 145.2 146.1 426.8 428.2 922.0 924.0
SD
CV
1 7.81
5.4
7.34
5.0
2 21.75
5.1
21.59
5.0
3 57.05
6.2
51.79
5.6
# Points 568 1716 489 1358 394 1224
# Labs 26 33 24 31 21 25

Mean 160.4 160.2 470.6 465.8 −− −−
SD
CV
1 5.72
3.6
4.98
3.1
2 20.20
4.3
17.11
3.7
3 −−
−−
−−
−−
# Points 27 82 28 82 −− −−
# Labs 1 1 1 1

Mean 224.0 226.3 577.6 589.5 1335 1392
SD
CV
1 11.59
5.2
18.49
8.2
2 34.99
6.1
40.34
6.8
3 81.23
6.1
92.72
6.7
# Points 12 32 14 57 21 65
# Labs 2 2 3 3 3 3

Mean 144.1 141.0 382.9 387.2 885.9 872.0
SD
CV
1 8.92
6.2
10.02
7.1
2 21.05
5.5
25.28
6.5
3 56.35
6.4
60.94
7.0
# Points 163 552 154 517 140 491
# Labs 14 16 13 15 12 14

Mean 131.1 128.3 349.0 354.9 801.9 797.0
SD
CV
1 11.73
8.9
11.09
8.6
2 21.15
6.1
21.99
6.2
3 61.58
7.7
64.10
8.0
# Points 812 3475 858 3166 901 3517
# Labs 46 56 44 54 48 57
DiaSorin LIAISON/XL • DiaSorin LIAISON Prolactin xt, REF 312171

Mean 111.2 154.9 341.5 424.8 −− −−
SD
CV
1 8.21
7.4
37.34
24.1
31.52
9.2
2 76.27
18.0
3 −−
−−
−−
−−
# Points 4 11 4 11 −− −−
# Labs 1 1 1 1


Dirui CS Series
Mean −− 6087 −− 27852 −− −−
SD
CV
1 −−
−−
201.7
3.3
2 −−
−−
879.1
3.2
3 −−
−−
−−
−−
# Points −− 57 −− 57 −− −−
# Labs 1 1
Mindray CL Series
Mean 189.1 187.2 6559 6353 1168 1168
SD
CV
1 5.63
3.0
6.41
3.4
2 10004
152.5
9988
157.2
3 38.09
3.3
38.09
3.3
# Points 35 45 44 191 3 3
# Labs 2 2 3 4 1 1

Mean 187.8 191.2 516.3 512.6 −− −−
SD
CV
1 6.55
3.5
7.91
4.1
2 23.08
4.5
23.14
4.5
3 −−
−−
−−
−−
# Points 8 24 8 24 −− −−
# Labs 1 1 1 1

Mean 115.1 115.5 308.7 307.9 690.4 691.8
SD
CV
1 5.99
5.2
6.51
5.6
2 22.16
7.2
20.33
6.6
3 55.05
8.0
52.95
7.7
# Points 42 119 47 116 27 98
# Labs 4 4 6 6 6 7

Mean 113.4 115.4 311.2 309.1 686.9 681.3
SD
CV
1 5.60
4.9
6.04
5.2
2 15.80
5.1
16.04
5.2
3 43.74
6.4
43.54
6.4
# Points 509 1866 530 1751 440 1384
# Labs 29 36 27 31 28 31

Mean 111.4 111.4 291.8 291.8 −− −−
SD
CV
1 4.60
4.1
4.60
4.1
2 11.18
3.8
11.18
3.8
3 −−
−−
−−
−−
# Points 8 8 8 8 −− −−
# Labs 1 1 1 1

Mean 112.6 112.0 302.4 300.6 666.5 670.7
SD
CV
1 4.67
4.1
4.52
4.0
2 12.11
4.0
12.65
4.2
3 28.30
4.2
32.25
4.8
# Points 456 2299 464 2309 416 2001
# Labs 18 19 18 19 17 17

Mean 152.6 148.8 401.9 394.5 935.3 913.0
SD
CV
1 9.87
6.5
9.19
6.2
2 23.11
5.8
22.11
5.6
3 59.64
6.4
51.86
5.7
# Points 86 204 89 208 60 167
# Labs 6 6 6 6 5 5

Mean 118.3 98.27 312.4 247.8 1068 794.5
SD
CV
1 67.86
57.4
75.54
76.9
2 215.0
68.8
224.1
90.4
3 57.66
5.4
459.0
57.8
# Points 23 35 29 47 18 30
# Labs 2 4 2 4 1 3
Tosoh AIA Models

Mean 27.03 26.78 148.4 146.5 162.2 160.6
SD
CV
1 1.06
3.9
1.61
6.0
2 6.00
4.0
5.69
3.9
3 6.59
4.1
19.11
11.9
# Points 4 19 4 19 4 19
# Labs 1 1 1 1 1 1


Mean 158.3 158.5 357.5 356.5 728.9 731.1
SD
CV
1 7.43
4.7
7.40
4.7
2 15.49
4.3
15.44
4.3
3 37.17
5.1
38.17
5.2
# Points 665 2877 608 2578 645 2781
# Labs 42 46 39 43 39 44

Mean 139.9 157.5 435.5 538.9 824.5 808.5
SD
CV
1 20.26
14.5
343.3
217.9
2 1145
262.9
2062
382.7
3 125.1
15.2
126.4
15.6
# Points 4680 17142 4567 16104 4253 15274
# Labs 241 281 233 272 226 257
Prolactin EIA ng/mL

Roche cobas c 303/503 • Roche Elecsys Prolactin II, REF 07027737
Mean 8.10 8.14 23.68 23.71 53.31 53.29
SD
CV
1 0.079
1.0
0.280
3.4
2
0.226
1.0
0.707
3.0
3 0.662
1.2
1.27
2.4
# Points 27 58 27 58 27 58
# Labs 1 1 1 1 1 1
Tosoh AIA Models

Mean 1.04 1.05 6.70 6.25 7.57 7.33
SD
CV
1 0.053
5.0
0.052
5.0
2 0.283
4.2
0.404
6.5
3 0.132
1.7
0.390
5.3
# Points 9 13 2 6 9 13
# Labs 1 2 1 2 1 2

Mean 6.34 6.84 22.51 22.07 41.87 44.87
SD
CV
1 3.10
48.9
2.77
40.6
2 4.38
19.5
5.17
23.4
3 20.10
48.0
17.94
40.0
# Points 36 71 29 64 36 71
# Labs 2 3 2 3 2 3
Prolactin EIA µIU/mL

Roche cobas c 303/503 • Roche Elecsys Prolactin II, REF 07027737
Mean 171.7 172.5 502.0 502.6 1130 1130
SD
CV
1 1.68
1.0
5.94
3.4
2
4.79
1.0
14.98
3.0
3 14.04
1.2
26.87
2.4
# Points 27 58 27 58 27 58
# Labs 1 1 1 1 1 1
Tosoh AIA Models

Mean 22.14 22.18 142.0 132.5 160.4 155.4
SD
CV
1 1.12
5.0
1.10
5.0
2 6.00
4.2
8.56
6.5
3 2.80
1.7
8.27
5.3
# Points 9 13 2 6 9 13
# Labs 1 2 1 2 1 2

Mean 134.3 145.0 477.1 467.9 887.7 951.3
SD
CV
1 65.70
48.9
58.80
40.6
2 92.94
19.5
109.7
23.4
3 426.0
48.0
380.3
40.0
# Points 36 71 29 64 36 71
# Labs 2 3 2 3 2 3
Prolactin Electrochemiluminescence (ECL) ng/mL

Mean −− 5.70 −− 19.35 −− 42.54
SD
CV
1 −−
−−
0.873
15.3
2 −−
−−
2.25
11.6
3 −−
−−
1.82
4.3
# Points −− 6 −− 6 −− 6
# Labs 1 1 1

Prolactin Electrochemiluminescence (ECL) ng/mL

Mean 8.15 8.14 24.09 23.93 53.84 53.74
SD
CV
1 0.305
3.7
0.391
4.8
2 1.26
5.2
1.28
5.3
3 2.90
5.4
2.94
5.5
# Points 553 1619 704 2234 647 1983
# Labs 40 45 42 47 38 43

Mean 7.97 8.04 23.43 23.75 53.31 53.15
SD
CV
1 0.385
4.8
0.395
4.9
2 1.09
4.7
1.20
5.1
3 2.31
4.3
2.70
5.1
# Points 799 2395 641 1932 386 1102
# Labs 27 30 24 26 20 22
Roche cobas e 402/801 • Roche Elecsys Prolactin II, REF 07027737

Mean 7.86 8.00 23.37 23.54 52.74 53.33
SD
CV
1 0.413
5.3
0.467
5.8
2
1.05
4.5
1.27
5.4
3 1.82
3.4
2.42
4.5
# Points 80 282 111 367 65 249
# Labs 5 7 6 8 5 7
Mean 8.29 8.14 24.25 24.53 54.26 53.01
SD
CV
1 0.164
2.0
0.259
3.2
2
0.545
2.2
0.731
3.0
3 1.22
2.3
2.68
5.1
# Points 22 107 22 107 22 107
# Labs 1 1 1 1 1 1
Roche cobas u 601

Mean 8.17 8.07 24.63 24.27 55.19 54.25
SD
CV
1 0.207
2.5
0.290
3.6
2 0.629
2.6
0.873
3.6
3 0.515
0.9
1.84
3.4
# Points 7 14 7 14 7 15
# Labs 1 1 1 1 1 1

Mean 8.23 8.28 24.36 24.47 55.08 55.47
SD
CV
1 0.512
6.2
0.527
6.4
2 1.38
5.7
1.50
6.1
3 3.97
7.2
34.91
62.9
# Points 693 2170 785 2379 644 1948
# Labs 44 47 49 51 44 49

Mean 7.83 8.06 23.46 24.16 53.03 53.76
SD
CV
1 0.211
2.7
0.330
4.1
2 0.599
2.6
0.876
3.6
3 0.941
1.8
1.61
3.0
# Points 18 60 17 63 18 56
# Labs 1 1 1 1 1 1

Mean 8.10 8.14 23.96 24.05 54.13 54.19
SD
CV
1 0.429
5.3
0.461
5.7
2 1.30
5.4
1.37
5.7
3 3.25
6.0
20.98
38.7
# Points 2172 6653 2287 7102 1789 5466
# Labs 119 133 124 136 110 125
Prolactin Electrochemiluminescence (ECL) µIU/mL

Mean −− 120.8 −− 410.2 −− 901.8
SD
CV
1 −−
−−
18.51
15.3
2 −−
−−
47.78
11.6
3 −−
−−
38.66
4.3
# Points −− 6 −− 6 −− 6
# Labs 1 1 1

Mean 172.7 172.6 510.7 507.3 1141 1139
SD
CV
1 6.46
3.7
8.29
4.8
2 26.78
5.2
27.13
5.3
3 61.42
5.4
62.33
5.5
# Points 553 1619 704 2234 647 1983
# Labs 40 45 42 47 38 43

Prolactin Electrochemiluminescence (ECL) µIU/mL

Mean 168.9 170.5 496.7 503.5 1130 1127
SD
CV
1 8.16
4.8
8.37
4.9
2 23.12
4.7
25.45
5.1
3 49.04
4.3
57.27
5.1
# Points 799 2395 641 1932 386 1102
# Labs 27 30 24 26 20 22
Roche cobas e 402/801 • Roche Elecsys Prolactin II, REF 07027737

Mean 166.7 169.5 495.4 499.0 1118 1131
SD
CV
1 8.76
5.3
9.89
5.8
2
22.36
4.5
26.91
5.4
3 38.50
3.4
51.27
4.5
# Points 80 282 111 367 65 249
# Labs 5 7 6 8 5 7
Mean 175.6 172.5 514.2 520.0 1150 1124
SD
CV
1 3.47
2.0
5.50
3.2
2
11.56
2.2
15.49
3.0
3 25.96
2.3
56.79
5.1
# Points 22 107 22 107 22 107
# Labs 1 1 1 1 1 1
Roche cobas u 601

Mean 173.3 171.1 522.1 514.6 1170 1150
SD
CV
1 4.38
2.5
6.15
3.6
2 13.34
2.6
18.51
3.6
3 10.91
0.9
39.08
3.4
# Points 7 14 7 14 7 15
# Labs 1 1 1 1 1 1

Mean 174.5 175.6 516.5 518.7 1168 1176
SD
CV
1 10.85
6.2
11.17
6.4
2 29.27
5.7
31.86
6.1
3 84.07
7.2
740.0
62.9
# Points 693 2170 785 2379 644 1948
# Labs 44 47 49 51 44 49

Mean 165.9 170.8 497.4 512.2 1124 1140
SD
CV
1 4.47
2.7
6.99
4.1
2 12.70
2.6
18.58
3.6
3 19.95
1.8
34.12
3.0
# Points 18 60 17 63 18 56
# Labs 1 1 1 1 1 1

Mean 171.6 172.6 508.0 509.8 1148 1149
SD
CV
1 9.09
5.3
9.77
5.7
2 27.62
5.4
29.14
5.7
3 68.93
6.0
444.8
38.7
# Points 2172 6653 2287 7102 1789 5466
# Labs 119 133 124 136 110 125
Prolactin FIA ng/mL

Mean 7.11 7.02 20.73 20.76 41.84 42.37
SD
CV
1 0.438
6.2
0.459
6.5
2 1.13
5.4
1.07
5.1
3 1.57
3.8
1.84
4.4
# Points 34 84 33 91 44 100
# Labs 2 2 2 3 3 3

Mean 7.11 7.02 20.73 20.76 41.84 42.37
SD
CV
1 0.438
6.2
0.459
6.5
2 1.13
5.4
1.07
5.1
3 1.57
3.8
1.84
4.4
# Points 34 84 33 91 44 100
# Labs 2 2 2 3 3 3

Prolactin FIA µIU/mL

Mean 150.8 148.9 439.5 440.2 887.0 898.3
SD
CV
1 9.29
6.2
9.74
6.5
2 23.93
5.4
22.61
5.1
3 33.27
3.8
39.09
4.4
# Points 34 84 33 91 44 100
# Labs 2 2 2 3 3 3

Mean 150.8 148.9 439.5 440.2 887.0 898.3
SD
CV
1 9.29
6.2
9.74
6.5
2 23.93
5.4
22.61
5.1
3 33.27
3.8
39.09
4.4
# Points 34 84 33 91 44 100
# Labs 2 2 2 3 3 3
Prolactin FPIA ng/mL

Mean 7.14 7.14 20.72 20.72 42.56 42.56
SD
CV
1 0.287
4.0
0.287
4.0
2 1.21
5.8
1.21
5.8
3 2.12
5.0
2.12
5.0
# Points 3 3 3 3 3 3
# Labs 1 1 1 1 1 1

Mean 7.14 7.14 20.72 20.72 42.56 42.56
SD
CV
1 0.287
4.0
0.287
4.0
2 1.21
5.8
1.21
5.8
3 2.12
5.0
2.12
5.0
# Points 3 3 3 3 3 3
# Labs 1 1 1 1 1 1
Prolactin FPIA µIU/mL

Mean 151.4 151.4 439.3 439.3 902.2 902.2
SD
CV
1 6.09
4.0
6.09
4.0
2 25.55
5.8
25.55
5.8
3 44.90
5.0
44.90
5.0
# Points 3 3 3 3 3 3
# Labs 1 1 1 1 1 1

Mean 151.4 151.4 439.3 439.3 902.2 902.2
SD
CV
1 6.09
4.0
6.09
4.0
2 25.55
5.8
25.55
5.8
3 44.90
5.0
44.90
5.0
# Points 3 3 3 3 3 3
# Labs 1 1 1 1 1 1
PSA, Free Chemiluminescence ng/mL

Mean 0.395 0.396 1.58 1.59 11.93 11.96
SD
CV
1 0.017
4.2
0.019
4.8
2 0.069
4.4
0.075
4.7
3 0.605
5.1
0.598
5.0
# Points 829 2619 751 2341 681 2337
# Labs 31 35 29 33 27 32
Abbott ARCHITECT/Alinity (c, i, ci models) • Alternate Calibration

Mean −− 0.424 −− 1.62 −− 12.45
SD
CV
1 −−
−−
0.017
4.0
2 −−
−−
0.036
2.2
3 −−
−−
0.658
5.3
# Points −− 23 −− 10 −− 38
# Labs 1 1 1

Mean 0.450 0.474 1.75 1.81 12.29 12.01
SD
CV
1 0.030
6.7
0.033
7.0
2 0.070
4.0
0.113
6.2
3 0.680
5.5
1.19
9.9
# Points 30 121 31 124 29 113
# Labs 1 1 1 1 1 1


Beckman Coulter Access, LXi 725, DxC 600i IA Systems • Beckman Coulter PSA, Hybritech Calibration
Mean 0.532 0.506 −− 1.83 13.80 12.88
SD
CV
1 0.031
5.8
0.042
8.4
−−
−−
2 0.111
6.1
3 0.760
5.5
1.08
8.4
# Points 34 71 −− 37 29 65
# Labs 2 3 1 1 2

Mean 0.477 0.478 1.83 1.84 12.37 12.36
SD
CV
1 0.030
6.3
0.030
6.3
2 0.100
5.5
0.105
5.7
3 0.931
7.5
0.852
6.9
# Points 231 991 248 1013 224 832
# Labs 14 18 14 16 13 14
Beckman Coulter UniCel DxI Series • Beckman Coulter PSA, Hybritech Calibration
Mean 0.467 0.464 1.82 1.80 12.50 12.29
SD
CV
1 0.022
4.8
0.025
5.4
0.095
5.2
2 0.089
4.9
3 0.690
5.5
0.725
5.9
# Points 173 459 262 732 282 861
# Labs 9 10 13 14 13 14
Beckman Coulter UniCel DxI Series • Beckman Coulter PSA, WHO Calibration
Mean 0.475 0.468 1.81 1.78 12.06 12.14
SD
CV
1 0.028
5.8
0.024
5.1
0.076
4.2
20.079
4.4
3 0.590
4.9
0.554
4.6
# Points 17 90 16 85 17 89
# Labs 1 1 1 1 1 1
DiaSorin LIAISON/XL
Mean 0.318 0.328 1.43 1.48 9.90 9.90
SD
CV
1 0.030
9.3
0.043
13.0
2 0.052
3.6
0.122
8.2
3 0.661
6.7
0.661
6.7
# Points 9 10 5 6 4 4
# Labs 2 2 1 1 1 1
Mindray CL Series
Mean 0.370 0.371 1.45 1.45 9.98 10.24
SD
CV
1 0.018
4.7
0.016
4.4
2 0.057
3.9
0.051
3.5
3 0.426
4.3
0.625
6.1
# Points 79 124 79 119 24 48
# Labs 4 4 4 4 2 2

Mean 0.400 0.398 1.40 1.37 9.93 9.54
SD
CV
1 0.000
0.0
0.014
3.5
2 0.000
0.0
0.058
4.2
3 0.263
2.6
0.313
3.3
# Points 3 52 2 47 4 48
# Labs 1 1 1 1 1 1

Mean 0.300 0.303 1.22 1.24 8.20 8.41
SD
CV
1 0.025
8.5
0.024
7.8
2 0.127
10.4
0.115
9.3
3 0.521
6.4
0.650
7.7
# Points 28 47 25 43 22 39
# Labs 3 3 3 3 2 2

Mean 1.14 0.732 1.19 1.14 8.54 10.00
SD
CV
1 0.071
6.2
0.532
72.6
2 0.156
13.1
0.121
10.5
3 0.684
8.0
0.670
6.7
# Points 3 8 3 9 6 86
# Labs 1 3 1 2 2 3

Mean 0.291 0.297 1.20 1.22 8.80 8.91
SD
CV
1 0.011
3.6
0.012
3.9
2 0.038
3.2
0.046
3.8
3 0.292
3.3
0.279
3.1
# Points 438 2192 373 2002 382 2048
# Labs 24 26 21 24 21 24


YHLO iFlash 3000
Mean −− −− 1.67 1.67 10.76 10.76
SD
CV
1 −−
−−
−−
−−
2 0.060
3.6
0.060
3.6
3 0.430
4.0
0.430
4.0
# Points −− −− 31 31 31 31
# Labs 1 1 1 1

Mean 0.390 0.383 1.57 1.54 11.31 11.04
SD
CV
1 0.076
19.4
0.074
19.4
2 0.235
15.0
0.251
16.3
3 1.61
14.3
1.62
14.7
# Points 1874 6784 1826 6589 1735 6601
# Labs 93 107 90 102 86 98
PSA, Free Electrochemiluminescence (ECL) ng/mL

Mean 0.350 0.456 1.63 1.77 9.71 10.15
SD
CV
1 0.000
0.0
0.063
13.9
2 0.000
0.0
0.114
6.4
3 0.000
0.0
0.987
9.7
# Points 1 10 1 10 1 10
# Labs 1 1 1 1 1 1

Mean 0.360 0.359 1.43 1.43 9.85 9.81
SD
CV
1 0.025
6.8
0.024
6.7
2 0.089
6.3
0.106
7.4
3 0.578
5.9
0.542
5.5
# Points 291 765 282 811 307 905
# Labs 20 20 19 20 21 22

Mean 0.361 0.356 1.43 1.42 9.65 9.55
SD
CV
1 0.016
4.6
0.017
4.7
2 0.049
3.4
0.048
3.4
3 0.335
3.5
0.407
4.3
# Points 374 1062 203 557 319 918
# Labs 17 20 11 14 14 17
Roche cobas e 402/801 • Roche Elecsys free PSA, REF 08828610

Mean 0.357 0.359 1.39 1.40 9.43 9.28
SD
CV
1 0.017
4.7
0.030
8.3
2
0.035
2.5
0.086
6.1
3 0.191
2.0
0.246
2.6
# Points 21 105 20 104 8 57
# Labs 3 3 3 3 2 2

Mean 0.356 0.345 1.44 1.43 9.94 9.61
SD
CV
1 0.025
7.0
0.029
8.3
2 0.091
6.3
0.093
6.5
3 0.552
5.6
0.700
7.3
# Points 45 110 71 104 71 148
# Labs 4 6 5 5 4 5

Mean 0.301 0.300 1.27 1.29 9.19 9.27
SD
CV
1 0.011
3.7
0.013
4.2
2 0.060
4.7
0.079
6.1
3 0.345
3.8
0.459
5.0
# Points 45 226 40 219 39 218
# Labs 2 3 2 3 2 3

Mean 0.357 0.351 1.42 1.41 9.73 9.63
SD
CV
1 0.024
6.8
0.028
7.9
2 0.085
6.0
0.102
7.2
3 0.500
5.1
0.525
5.5
# Points 777 2278 617 1805 745 2256
# Labs 47 53 41 46 44 50
PSA, Total Chemiluminescence ng/mL

1drop
Mean 0.680 0.727 −− −− 11.69 12.87
SD
CV
1 0.020
2.9
0.042
5.8
2 −−
−−
−−
−−
3 0.280
2.4
0.548
4.3
# Points 23 211 −− −− 23 407
# Labs 1 1 1 1

Mean 0.628 0.624 2.21 2.20 15.24 15.24
SD
CV
1 0.035
5.5
0.035
5.6
2 0.115
5.2
0.118
5.4
3 0.794
5.2
0.882
5.8
# Points 1558 5496 1298 4225 1434 5082
# Labs 67 75 58 66 66 74
Abbott ARCHITECT/Alinity (c, i, ci models) • Abbott AxSYM Total PSA (7K53)

Mean 0.609 0.637 2.11 2.24 −− −−
SD
CV
1 0.020
3.4
0.039
6.2
0.061
2.9
2 0.169
7.5
3 −−
−−
−−
−−
# Points 7 18 7 17 −− −−
# Labs 1 1 1 1

Mean 0.747 0.743 2.35 2.33 17.42 17.43
SD
CV
1 0.031
4.2
0.024
3.2
2 0.154
6.6
0.112
4.8
3 0.541
3.1
0.895
5.1
# Points 12 30 13 33 16 37
# Labs 2 2 2 2 2 2

Mean 0.960 0.901 3.06 3.05 21.15 20.14
SD
CV
1 0.046
4.8
0.080
8.9
2 0.167
5.4
0.171
5.6
3 1.03
4.8
2.16
10.7
# Points 176 1094 186 660 202 1144
# Labs 10 11 11 11 12 12
Beckman Coulter Access, LXi 725, DxC 600i IA Systems • Beckman Coulter PSA, Hybritech Calibration
Mean 0.942 0.925 3.01 3.00 21.44 20.87
SD
CV
1 0.081
8.5
0.064
6.9
0.144
4.8
2
0.147
4.9
3 1.43
6.7
1.29
6.2
# Points 158 702 114 451 159 676
# Labs 9 11 6 7 9 11

Mean 0.904 0.900 2.91 2.92 20.33 20.44
SD
CV
1 0.052
5.8
0.057
6.3
2 0.146
5.0
0.173
5.9
3 1.18
5.8
1.30
6.4
# Points 369 1584 389 1568 271 1016
# Labs 18 22 17 20 15 16
Beckman Coulter UniCel DxI Series • Beckman Coulter PSA, Hybritech Calibration
Mean 0.887 0.879 2.85 2.84 20.02 19.99
SD
CV
1 0.048
5.4
0.054
6.1
0.132
4.6
20.155
5.4
3 1.10
5.5
1.15
5.7
# Points 300 890 283 660 336 915
# Labs 14 15 14 15 16 17
Beckman Coulter UniCel DxI Series • Beckman Coulter PSA, WHO Calibration
Mean 0.890 0.894 2.90 2.91 20.01 20.50
SD
CV
1 0.053
6.0
0.052
5.8
0.210
7.2
2
0.159
5.5
3 1.17
5.8
1.19
5.8
# Points 94 430 99 442 114 458
# Labs 5 5 5 5 5 6
DiaSorin LIAISON/XL
Mean 0.488 0.494 1.95 1.99 15.32 15.32
SD
CV
1 0.043
8.8
0.044
8.9
2 0.133
6.8
0.144
7.2
3 1.33
8.7
1.33
8.7
# Points 9 10 5 6 4 4
# Labs 2 2 1 1 1 1

Mindray CL Series
Mean 0.759 0.759 2.55 2.56 18.01 17.96
SD
CV
1 0.031
4.0
0.033
4.3
2 0.093
3.7
0.098
3.8
3 0.629
3.5
1.06
5.9
# Points 87 134 87 129 23 49
# Labs 4 4 4 4 2 2

Mean 0.711 0.709 2.30 2.31 15.87 16.02
SD
CV
1 0.064
9.1
0.063
8.8
2 0.138
6.0
0.168
7.3
3 0.875
5.5
1.33
8.3
# Points 97 155 90 162 88 152
# Labs 5 5 4 5 6 6

Mean 0.710 0.700 2.34 2.25 −− −−
SD
CV
1 0.030
4.2
0.024
3.5
2
0.070
3.0
0.135
6.0
3 −−
−−
−−
−−
# Points 17 55 14 41 −− −−
# Labs 1 1 1 1

Mean 0.723 0.716 2.31 2.30 16.35 16.28
SD
CV
1 0.052
7.2
0.125
17.4
2 0.158
6.8
0.157
6.8
3 1.02
6.2
1.01
6.2
# Points 436 1351 476 1378 465 1343
# Labs 24 27 26 28 27 28

Mean 0.702 0.699 2.31 2.31 16.40 16.37
SD
CV
1 0.037
5.3
0.036
5.1
2 0.114
4.9
0.108
4.7
3 0.818
5.0
0.693
4.2
# Points 484 1818 480 1771 470 1742
# Labs 15 15 15 15 15 15

Mean 0.810 0.765 2.67 2.60 18.73 18.56
SD
CV
1 0.030
3.7
0.047
6.1
2 0.080
3.0
0.119
4.6
3 0.340
1.8
0.581
3.1
# Points 25 132 24 132 24 132
# Labs 1 1 1 1 1 1

Mean 0.707 0.686 2.44 2.39 17.35 17.23
SD
CV
1 0.054
7.7
0.066
9.7
2 0.167
6.8
0.196
8.2
3 0.781
4.5
1.01
5.9
# Points 78 182 79 187 53 146
# Labs 4 4 4 4 3 3

Mean −− 0.607 −− 2.08 15.48 14.26
SD
CV
1 −−
−−
0.064
10.5
2 −−
−−
0.227
10.9
3 0.915
5.9
1.49
10.5
# Points −− 11 −− 14 5 18
# Labs 2 3 1 2

Mean 0.660 0.660 2.25 2.25 16.28 16.28
SD
CV
1 0.010
1.5
0.010
1.5
2 0.040
1.8
0.040
1.8
3 0.210
1.3
0.210
1.3
# Points 11 11 11 11 10 10
# Labs 1 1 1 1 1 1

Mean 0.704 0.711 2.36 2.42 17.19 17.32
SD
CV
1 0.024
3.4
0.032
4.6
2 0.193
8.2
0.157
6.5
3 0.558
3.2
0.611
3.5
# Points 519 2758 578 2935 443 2504
# Labs 23 27 26 29 20 24

VITROS Microwell Series • VITROS MICROWELL PSA, REF 188 6704/680 1756
Mean 0.708 0.726 2.14 2.12 12.51 12.90
SD
CV
1 0.036
5.1
0.042
5.8
0.226
10.6
2
0.156
7.3
3 0.553
4.4
0.830
6.4
# Points 166 1058 79 363 114 960
# Labs 10 13 6 9 5 8
VITROS Microwell Series • VITROS MICROWELL Total PSA II, REF 684 2844
Mean 0.700 0.707 2.39 2.42 16.88 16.94
SD
CV
1 0.027
3.9
0.032
4.5
0.131
5.5
20.151
6.2
3 0.700
4.1
1.15
6.8
# Points 488 2374 407 2073 472 2377
# Labs 26 28 22 24 23 26
YHLO iFlash 3000

Mean −− −− 3.88 3.88 27.17 27.17
SD
CV
1 −−
−−
−−
−−
2 0.160
4.1
0.160
4.1
3 1.24
4.6
1.24
4.6
# Points −− −− 20 20 20 20
# Labs 1 1 1 1

Mean 0.728 0.731 2.45 2.45 17.06 16.92
SD
CV
1 0.113
15.5
0.113
15.5
2 0.329
13.4
0.314
12.8
3 2.41
14.1
2.42
14.3
# Points 5097 20449 4725 17237 4746 19192
# Labs 242 272 225 252 232 257
PSA, Total EIA ng/mL

Mean 0.740 0.776 2.48 2.61 17.73 17.97
SD
CV
1 0.053
7.2
0.074
9.6
2 0.175
7.1
0.268
10.3
3 0.772
4.4
0.971
5.4
# Points 282 1277 257 1177 136 536
# Labs 11 12 11 12 6 7
Tosoh AIA Models

Mean 0.674 0.674 2.11 2.09 14.19 14.46
SD
CV
1 0.018
2.7
0.036
5.4
2 0.055
2.6
0.104
5.0
3 0.336
2.4
0.480
3.3
# Points 48 254 50 259 25 77
# Labs 2 3 2 3 1 2

Mean 0.730 0.759 2.42 2.51 17.18 17.53
SD
CV
1 0.055
7.5
0.079
10.4
2 0.212
8.7
0.316
12.6
3 1.48
8.6
1.49
8.5
# Points 330 1531 307 1436 161 613
# Labs 13 15 13 15 7 9
PSA, Total Electrochemiluminescence (ECL) ng/mL

Mean −− 0.790 −− 2.54 −− 17.11
SD
CV
1 −−
−−
0.000
0.0
2 −−
−−
0.000
0.0
3 −−
−−
0.000
0.0
# Points −− 1 −− 1 −− 1
# Labs 1 1 1

Mean 0.779 0.781 2.55 2.55 17.44 17.38
SD
CV
1 0.036
4.7
0.036
4.6
2 0.126
4.9
0.120
4.7
3 0.862
4.9
0.835
4.8
# Points 689 2519 709 2481 707 2481
# Labs 36 42 36 41 37 40
PSA, Total Electrochemiluminescence (ECL) ng/mL

Roche cobas 6000/8000/c 311 • Roche ECL e 801
Mean −− −− 2.55 2.48 17.60 16.92
SD
CV
1 −−
−−
−−
−−
2 0.040
1.6
0.139
5.6
3 0.512
2.9
0.899
5.3
# Points −− −− 23 124 19 97
# Labs 1 1 1 1
Roche cobas 6000/8000/c 311 • Roche Elecsys total PSA, REF 08791732
Mean 0.802 0.804 2.64 2.65 18.13 18.11
SD
CV
1 0.021
2.6
0.020
2.5
2
0.069
2.6
0.066
2.5
3 0.423
2.3
0.407
2.2
# Points 25 33 25 33 24 34
# Labs 1 1 1 1 1 1

Mean 0.758 0.753 2.53 2.52 16.90 16.89
SD
CV
1 0.041
5.5
0.038
5.0
2 0.107
4.2
0.108
4.3
3 0.796
4.7
0.735
4.4
# Points 699 2068 293 1004 554 1727
# Labs 26 33 17 24 21 29
Roche cobas e 402/801 • Roche Elecsys total PSA, REF 08791686/08791716

Mean 0.786 0.764 2.54 2.51 −− −−
SD
CV
1 0.061
7.7
0.039
5.1
2
0.073
2.9
0.123
4.9
3 −−
−−
−−
−−
# Points 15 48 15 48 −− −−
# Labs 1 1 1 1
Roche cobas e 402/801 • Roche Elecsys total PSA, REF 08791732

Mean 0.764 0.763 2.51 2.50 17.23 17.16
SD
CV
1 0.016
2.1
0.019
2.5
2
0.049
2.0
0.056
2.2
3 0.252
1.5
0.404
2.4
# Points 73 133 72 132 72 130
# Labs 4 4 4 4 4 4

Mean 0.812 0.824 2.62 2.64 17.31 17.57
SD
CV
1 0.063
7.8
0.063
7.7
2 0.181
6.9
0.189
7.1
3 0.985
5.7
1.06
6.0
# Points 459 1443 480 1455 416 1180
# Labs 33 35 35 35 31 34

Mean 0.857 0.812 2.75 2.60 18.37 17.42
SD
CV
1 0.020
2.4
0.040
4.9
2 0.043
1.6
0.131
5.1
3 0.320
1.7
0.946
5.4
# Points 18 59 18 61 17 49
# Labs 1 1 1 1 1 1
Roche Elecsys / cobas e 411 Series • Roche Elecsys total PSA, REF 08791686/08791716
Mean 0.809 0.809 2.64 2.64 17.68 17.71
SD
CV
1 0.029
3.6
0.032
3.9
2
0.073
2.8
0.078
3.0
3 0.484
2.7
0.532
3.0
# Points 22 137 22 137 21 135
# Labs 1 1 1 1 1 1

Mean 0.780 0.782 2.57 2.57 17.26 17.27
SD
CV
1 0.050
6.4
0.051
6.6
2 0.143
5.5
0.148
5.8
3 0.886
5.1
0.889
5.1
# Points 2000 6441 1657 5476 1830 5834
# Labs 103 119 97 110 97 112
PSA, Total FIA ng/mL

Mean 1.03 1.03 3.15 3.12 21.02 20.87
SD
CV
1 0.042
4.1
0.049
4.7
2 0.147
4.7
0.166
5.3
3 1.00
4.8
1.02
4.9
# Points 41 111 39 103 42 108
# Labs 3 3 3 3 3 3
PSA, Total FIA ng/mL

Mean 1.03 1.03 3.15 3.12 21.02 20.87
SD
CV
1 0.042
4.1
0.049
4.7
2 0.147
4.7
0.166
5.3
3 1.00
4.8
1.02
4.9
# Points 41 111 39 103 42 108
# Labs 3 3 3 3 3 3
PSA, Total Immunoturbidimetric ng/mL

Mean 0.666 0.664 −− −− 15.80 15.80
SD
CV
1 0.020
3.0
0.025
3.8
2 −−
−−
−−
−−
3 0.524
3.3
0.520
3.3
# Points 35 51 −− −− 33 49
# Labs 1 1 1 1

Mean 0.666 0.664 −− −− 15.80 15.80
SD
CV
1 0.020
3.0
0.025
3.8
2 −−
−−
−−
−−
3 0.524
3.3
0.520
3.3
# Points 35 51 −− −− 33 49
# Labs 1 1 1 1
PTH, C−Terminal Chemiluminescence ng/mL

Mean −− −− −− 0.094 −− −−
SD
CV
1 −−
−−
−−
−−
2 −−
−−
0.024
25.3
3 −−
−−
−−
−−
# Points −− −− −− 3 −− −−
# Labs 1

Mean −− −− −− 0.094 −− −−
SD
CV
1 −−
−−
−−
−−
2 −−
−−
0.024
25.3
3 −−
−−
−−
−−
# Points −− −− −− 3 −− −−
# Labs 1
PTH, C−Terminal Chemiluminescence pg/mL

Mean −− −− −− 93.97 −− −−
SD
CV
1 −−
−−
−−
−−
2 −−
−−
23.77
25.3
3 −−
−−
−−
−−
# Points −− −− −− 3 −− −−
# Labs 1

Mean −− −− −− 93.97 −− −−
SD
CV
1 −−
−−
−−
−−
2 −−
−−
23.77
25.3
3 −−
−−
−−
−−
# Points −− −− −− 3 −− −−
# Labs 1
PTH, Intact Chemiluminescence ng/dL

Mean 2.79 2.74 14.70 16.37 47.35 51.49
SD
CV
1 0.158
5.7
0.344
12.6
2 0.846
5.8
2.03
12.4
3 4.74
10.0
4.19
8.1
# Points 39 109 39 233 37 215
# Labs 2 3 2 4 2 3

Mean −− 1.98 −− 10.70 −− −−
SD
CV
1 −−
−−
0.132
6.7
2 −−
−−
0.616
5.8
3 −−
−−
−−
−−
# Points −− 69 −− 69 −− −−
# Labs 1 1
PTH, Intact Chemiluminescence ng/dL

Beckman Coulter UniCel DxI Series • Beckman Coulter Access PTH − (Routine)
Mean 1.93 1.93 12.26 12.49 36.32 36.76
SD
CV
1 0.102
5.3
0.095
4.9
2
0.730
6.0
0.825
6.6
3 1.51
4.2
2.21
6.0
# Points 31 94 121 291 93 218
# Labs 2 2 5 5 4 4
Beckman Coulter UniCel DxI Series • Beckman Coulter Access PTHIO (Intraoperative)
Mean −− −− 10.09 9.30 −− −−
SD
CV
1 −−
−−
−−
−−
2
0.000
0.0
1.36
14.6
3 −−
−−
−−
−−
# Points −− −− 1 30 −− −−
# Labs 1 1
Mindray CL Series
Mean 2.18 2.12 12.46 12.14 37.90 37.21
SD
CV
1 0.135
6.2
0.153
7.2
2 0.724
5.8
0.755
6.2
3 1.81
4.8
1.89
5.1
# Points 13 21 13 21 13 21
# Labs 1 1 1 1 1 1

Mean −− −− −− 10.13 −− −−
SD
CV
1 −−
−−
−−
−−
2 −−
−−
2.31
22.8
3 −−
−−
−−
−−
# Points −− −− −− 7 −− −−
# Labs 1
Siemens ADVIA Centaur Systems • Siemens Centaur iPTH, REF 0658575/04385983

Mean 1.18 1.20 13.65 13.51 −− −−
SD
CV
1 0.080
6.8
0.097
8.0
0.483
3.5
2 0.747
5.5
3 −−
−−
−−
−−
# Points 38 205 36 210 −− −−
# Labs 1 1 1 1

Mean 0.820 0.842 −− −− 33.98 34.82
SD
CV
1 0.175
21.3
0.186
22.1
2 −−
−−
−−
−−
3 3.72
10.9
3.74
10.7
# Points 31 36 −− −− 33 51
# Labs 1 2 1 1

Mean 2.66 2.64 16.35 16.77 53.91 53.05
SD
CV
1 0.346
13.0
0.314
11.9
2 0.986
6.0
1.25
7.4
3 5.74
10.6
5.17
9.7
# Points 10 26 11 25 9 21
# Labs 1 1 1 1 1 1

Mean 4.74 4.92 13.04 13.04 42.78 42.58
SD
CV
1 0.762
16.1
0.524
10.7
2 0.483
3.7
0.465
3.6
3 2.01
4.7
2.03
4.8
# Points 3 6 33 49 34 48
# Labs 1 1 2 2 2 2

Mean 1.93 2.03 13.29 13.65 42.08 42.21
SD
CV
1 0.112
5.8
0.161
7.9
2 0.660
5.0
0.846
6.2
3 1.76
4.2
1.45
3.4
# Points 25 130 25 130 25 116
# Labs 1 2 1 2 1 1

Mean 1.87 1.87 13.14 13.70 39.90 43.04
SD
CV
1 0.805
43.0
0.672
36.0
2 1.28
9.7
2.11
15.4
3 5.95
14.9
7.31
17.0
# Points 190 696 278 1035 244 690
# Labs 10 14 13 18 12 13
PTH, Intact Chemiluminescence ng/mL

Mean 0.028 0.027 0.147 0.164 0.474 0.515
SD
CV
1 0.002
5.7
0.003
12.6
2 0.008
5.8
0.020
12.4
3 0.047
10.0
0.042
8.1
# Points 39 109 39 233 37 215
# Labs 2 3 2 4 2 3

Mean −− 0.020 −− 0.107 −− −−
SD
CV
1 −−
−−
0.001
6.7
2 −−
−−
0.006
5.8
3 −−
−−
−−
−−
# Points −− 69 −− 69 −− −−
# Labs 1 1
Mean 0.019 0.019 0.123 0.125 0.363 0.368
SD
CV
1 0.001
5.3
0.001
4.9
0.007
6.0
2 0.008
6.6
3 0.015
4.2
0.022
6.0
# Points 31 94 121 291 93 218
# Labs 2 2 5 5 4 4
Mean −− −− 0.101 0.093 −− −−
SD
CV
1 −−
−−
−−
−−
0.000
0.0
2 0.014
14.6
3 −−
−−
−−
−−
# Points −− −− 1 30 −− −−
# Labs 1 1
Mindray CL Series
Mean 0.022 0.021 0.125 0.121 0.379 0.372
SD
CV
1 0.001
6.2
0.002
7.2
2 0.007
5.8
0.008
6.2
3 0.018
4.8
0.019
5.1
# Points 13 21 13 21 13 21
# Labs 1 1 1 1 1 1

Mean −− −− −− 0.101 −− −−
SD
CV
1 −−
−−
−−
−−
2 −−
−−
0.023
22.8
3 −−
−−
−−
−−
# Points −− −− −− 7 −− −−
# Labs 1

Mean 0.012 0.012 0.136 0.135 −− −−
SD
CV
1 0.001
6.8
0.001
8.0
0.005
3.5
2
0.007
5.5
3 −−
−−
−−
−−
# Points 38 205 36 210 −− −−
# Labs 1 1 1 1

Mean 0.008 0.008 −− −− 0.340 0.348
SD
CV
1 0.002
21.3
0.002
22.1
2 −−
−−
−−
−−
3 0.037
10.9
0.037
10.7
# Points 31 36 −− −− 33 51
# Labs 1 2 1 1

Mean 0.027 0.026 0.164 0.168 0.539 0.531
SD
CV
1 0.003
13.0
0.003
11.9
2 0.010
6.0
0.012
7.4
3 0.057
10.6
0.052
9.7
# Points 10 26 11 25 9 21
# Labs 1 1 1 1 1 1

Mean 0.047 0.049 0.130 0.130 0.428 0.426
SD
CV
1 0.008
16.1
0.005
10.7
2 0.005
3.7
0.005
3.6
3 0.020
4.7
0.020
4.8
# Points 3 6 33 49 34 48
# Labs 1 1 2 2 2 2
PTH, Intact Chemiluminescence ng/mL

Mean 0.019 0.020 0.133 0.137 0.421 0.422
SD
CV
1 0.001
5.8
0.002
7.9
2 0.007
5.0
0.008
6.2
3 0.018
4.2
0.014
3.4
# Points 25 130 25 130 25 116
# Labs 1 2 1 2 1 1

Mean 0.019 0.019 0.131 0.137 0.399 0.430
SD
CV
1 0.008
43.0
0.007
36.0
2 0.013
9.7
0.021
15.4
3 0.059
14.9
0.073
17.0
# Points 190 696 278 1035 244 690
# Labs 10 14 13 18 12 13
PTH, Intact Chemiluminescence pg/mL

Mean 27.89 27.36 147.0 163.7 473.5 514.9
SD
CV
1 1.58
5.7
3.44
12.6
2 8.46
5.8
20.33
12.4
3 47.40
10.0
41.86
8.1
# Points 39 109 39 233 37 215
# Labs 2 3 2 4 2 3

Mean −− 19.79 −− 107.0 −− −−
SD
CV
1 −−
−−
1.32
6.7
2 −−
−−
6.16
5.8
3 −−
−−
−−
−−
# Points −− 69 −− 69 −− −−
# Labs 1 1
Mean 19.26 19.26 122.6 124.9 363.2 367.6
SD
CV
1 1.02
5.3
0.947
4.9
2
7.30
6.0
8.25
6.6
3 15.15
4.2
22.11
6.0
# Points 31 94 121 291 93 218
# Labs 2 2 5 5 4 4
Mean −− −− 100.9 92.98 −− −−
SD
CV
1 −−
−−
−−
−−
2
0.000
0.0
13.60
14.6
3 −−
−−
−−
−−
# Points −− −− 1 30 −− −−
# Labs 1 1
Mindray CL Series
Mean 21.76 21.15 124.6 121.4 379.0 372.1
SD
CV
1 1.35
6.2
1.53
7.2
2 7.24
5.8
7.55
6.2
3 18.06
4.8
18.89
5.1
# Points 13 21 13 21 13 21
# Labs 1 1 1 1 1 1

Mean −− −− −− 101.3 −− −−
SD
CV
1 −−
−−
−−
−−
2 −−
−−
23.10
22.8
3 −−
−−
−−
−−
# Points −− −− −− 7 −− −−
# Labs 1

Mean 11.82 12.02 136.5 135.1 −− −−
SD
CV
1 0.800
6.8
0.966
8.0
4.83
3.5
2 7.47
5.5
3 −−
−−
−−
−−
# Points 38 205 36 210 −− −−
# Labs 1 1 1 1

Mean 8.20 8.42 −− −− 339.8 348.2
SD
CV
1 1.75
21.3
1.86
22.1
2 −−
−−
−−
−−
3 37.21
10.9
37.37
10.7
# Points 31 36 −− −− 33 51
# Labs 1 2 1 1
PTH, Intact Chemiluminescence pg/mL

Mean 26.61 26.40 163.5 167.7 539.1 530.5
SD
CV
1 3.46
13.0
3.14
11.9
2 9.86
6.0
12.48
7.4
3 57.37
10.6
51.69
9.7
# Points 10 26 11 25 9 21
# Labs 1 1 1 1 1 1

Mean 47.37 49.20 130.4 130.4 427.8 425.8
SD
CV
1 7.62
16.1
5.24
10.7
2 4.83
3.7
4.65
3.6
3 20.12
4.7
20.26
4.8
# Points 3 6 33 49 34 48
# Labs 1 1 2 2 2 2

Mean 19.25 20.35 132.9 136.5 420.8 422.1
SD
CV
1 1.12
5.8
1.61
7.9
2 6.60
5.0
8.46
6.2
3 17.64
4.2
14.47
3.4
# Points 25 130 25 130 25 116
# Labs 1 2 1 2 1 1

Mean 18.74 18.67 131.4 137.0 399.0 430.4
SD
CV
1 8.05
43.0
6.72
36.0
2 12.76
9.7
21.08
15.4
3 59.48
14.9
73.13
17.0
# Points 190 696 278 1035 244 690
# Labs 10 14 13 18 12 13
PTH, Intact Electrochemiluminescence (ECL) ng/dL

Mean 1.65 1.64 8.86 8.76 30.01 28.17
SD
CV
1 0.157
9.6
0.118
7.2
2 0.459
5.2
0.436
5.0
3 1.66
5.5
1.52
5.4
# Points 65 292 42 255 30 208
# Labs 4 9 3 8 2 7
Roche cobas 6000/8000/c 311 • Roche Elecsys PTH REF 11972103

Mean −− −− 8.43 8.59 26.77 26.43
SD
CV
1 −−
−−
−−
−−
0.555
6.6
2 0.681
7.9
3 1.30
4.8
1.76
6.7
# Points −− −− 6 84 6 83
# Labs 2 2 2 2

Mean 1.67 1.68 −− 8.33 27.41 27.42
SD
CV
1 0.049
2.9
0.104
6.2
2 −−
−−
0.252
3.0
3 0.615
2.2
1.14
4.1
# Points 27 91 −− 11 27 70
# Labs 1 2 1 1 2

Mean 4.34 2.74 18.01 13.06 29.34 29.19
SD
CV
1 1.93
44.5
1.78
65.0
2 0.463
2.6
4.84
37.1
3 1.03
3.5
1.22
4.2
# Points 4 126 4 88 2 66
# Labs 2 4 1 2 2 2
Roche Elecsys / cobas e 411 Series • Roche Elecsys PTH REF 07251068
Mean 1.56 1.57 8.01 8.05 −− −−
SD
CV
1 0.039
2.5
0.041
2.6
0.215
2.7
2 0.210
2.6
3 −−
−−
−−
−−
# Points 28 52 28 52 −− −−
# Labs 1 1 1 1

Mean 1.72 1.89 8.99 9.42 28.61 27.87
SD
CV
1 0.580
33.8
0.963
51.0
2 2.16
24.0
2.70
28.7
3 1.85
6.5
1.70
6.1
# Points 124 561 80 490 65 427
# Labs 8 16 7 14 7 13
PTH, Intact Electrochemiluminescence (ECL) ng/mL

Mean 0.016 0.016 0.089 0.088 0.300 0.282
SD
CV
1 0.002
9.6
0.001
7.2
2 0.005
5.2
0.004
5.0
3 0.017
5.5
0.015
5.4
# Points 65 292 42 255 30 208
# Labs 4 9 3 8 2 7

Mean −− −− 0.084 0.086 0.268 0.264
SD
CV
1 −−
−−
−−
−−
2
0.006
6.6
0.007
7.9
3 0.013
4.8
0.018
6.7
# Points −− −− 6 84 6 83
# Labs 2 2 2 2

Mean 0.017 0.017 −− 0.083 0.274 0.274
SD
CV
1 0.000
2.9
0.001
6.2
2 −−
−−
0.003
3.0
3 0.006
2.2
0.011
4.1
# Points 27 91 −− 11 27 70
# Labs 1 2 1 1 2

Mean 0.043 0.027 0.180 0.131 0.293 0.292
SD
CV
1 0.019
44.5
0.018
65.0
2 0.005
2.6
0.048
37.1
3 0.010
3.5
0.012
4.2
# Points 4 126 4 88 2 66
# Labs 2 4 1 2 2 2
Mean 0.016 0.016 0.080 0.081 −− −−
SD
CV
1 0.000
2.5
0.000
2.6
2
0.002
2.7
0.002
2.6
3 −−
−−
−−
−−
# Points 28 52 28 52 −− −−
# Labs 1 1 1 1

Mean 0.017 0.019 0.090 0.094 0.286 0.279
SD
CV
1 0.006
33.8
0.010
51.0
2 0.022
24.0
0.027
28.7
3 0.018
6.5
0.017
6.1
# Points 124 561 80 490 65 427
# Labs 8 16 7 14 7 13
PTH, Intact Electrochemiluminescence (ECL) pg/mL

Mean 16.46 16.40 88.62 87.64 300.1 281.7
SD
CV
1 1.57
9.6
1.18
7.2
2 4.59
5.2
4.36
5.0
3 16.57
5.5
15.18
5.4
# Points 65 292 42 255 30 208
# Labs 4 9 3 8 2 7

Mean −− −− 84.27 85.89 267.7 264.3
SD
CV
1 −−
−−
−−
−−
2
5.55
6.6
6.81
7.9
3 12.97
4.8
17.59
6.7
# Points −− −− 6 84 6 83
# Labs 2 2 2 2

Mean 16.70 16.82 −− 83.29 274.1 274.2
SD
CV
1 0.490
2.9
1.04
6.2
2 −−
−−
2.52
3.0
3 6.15
2.2
11.36
4.1
# Points 27 91 −− 11 27 70
# Labs 1 2 1 1 2

Mean 43.37 27.36 180.1 130.6 293.4 291.9
SD
CV
1 19.32
44.5
17.80
65.0
2 4.63
2.6
48.41
37.1
3 10.32
3.5
12.16
4.2
# Points 4 126 4 88 2 66
# Labs 2 4 1 2 2 2
PTH, Intact Electrochemiluminescence (ECL) pg/mL

Mean 15.58 15.66 80.07 80.52 −− −−
SD
CV
1 0.387
2.5
0.410
2.6
2.15
2.7
2 2.10
2.6
3 −−
−−
−−
−−
# Points 28 52 28 52 −− −−
# Labs 1 1 1 1

Mean 17.18 18.86 89.87 94.20 286.1 278.7
SD
CV
1 5.80
33.8
9.63
51.0
2 21.55
24.0
27.02
28.7
3 18.46
6.5
17.04
6.1
# Points 124 561 80 490 65 427
# Labs 8 16 7 14 7 13
Salicylate Colorimetric mg/dL

Mean −− −− 15.46 15.51 43.90 43.81
SD
CV
1 −−
−−
−−
−−
2 0.368
2.4
0.409
2.6
3 0.465
1.1
0.667
1.5
# Points −− −− 30 45 31 45
# Labs 1 1 1 1
Method Group • Colorimetric

Mean −− −− 15.46 15.51 43.90 43.81
SD
CV
1 −−
−−
−−
−−
2 0.368
2.4
0.409
2.6
3 0.465
1.1
0.667
1.5
# Points −− −− 30 45 31 45
# Labs 1 1 1 1
Salicylate Colorimetric−VITROS mg/dL

Mean −− 4.63 −− 17.02 −− 38.77
SD
CV
1 −−
−−
0.165
3.6
2 −−
−−
0.466
2.7
3 −−
−−
0.726
1.9
# Points −− 153 −− 155 −− 19
# Labs 3 3 1

Mean 4.30 4.41 17.95 17.34 −− 37.20
SD
CV
1 0.104
2.4
0.208
4.7
2 0.614
3.4
0.683
3.9
3 −−
−−
1.77
4.8
# Points 10 36 11 38 −− 8
# Labs 1 3 1 3 1
Method Group • Colorimetric−VITROS

Mean 4.30 4.59 17.95 17.08 −− 37.38
SD
CV
1 0.104
2.4
0.193
4.2
2 0.614
3.4
0.530
3.1
3 −−
−−
1.29
3.4
# Points 10 189 11 193 −− 83
# Labs 1 6 1 6 2
Salicylate EIA mg/dL

Mean 3.75 3.75 −− −− 43.00 43.00
SD
CV
1 0.300
8.0
0.300
8.0
2 −−
−−
−−
−−
3 2.00
4.7
2.00
4.7
# Points 30 30 −− −− 33 33
# Labs 1 1 1 1

Mean 3.75 3.75 −− −− 43.00 43.00
SD
CV
1 0.300
8.0
0.300
8.0
2 −−
−−
−−
−−
3 2.00
4.7
2.00
4.7
# Points 30 30 −− −− 33 33
# Labs 1 1 1 1
Salicylate Enzymatic mg/dL

Mean 4.56 4.92 15.68 15.34 44.41 44.96
SD
CV
1 0.826
18.1
0.406
8.2
2 0.522
3.3
0.621
4.0
3 1.08
2.4
1.02
2.3
# Points 40 204 40 362 40 361
# Labs 3 3 3 4 3 4

Mean 3.70 3.70 15.01 15.08 43.77 43.86
SD
CV
1 0.142
3.9
0.167
4.5
2 0.345
2.3
0.383
2.5
3 1.11
2.5
1.17
2.7
# Points 174 1235 173 1235 174 1238
# Labs 3 4 3 4 3 4

Mean 3.87 3.80 −− −− 44.17 43.66
SD
CV
1 0.132
3.4
0.172
4.5
2 −−
−−
−−
−−
3 1.01
2.3
1.12
2.6
# Points 63 111 −− −− 63 111
# Labs 2 2 2 2
Method Group • Enzymatic

Mean 3.86 3.87 15.13 15.14 43.95 44.08
SD
CV
1 0.449
11.6
0.464
12.0
2 0.464
3.1
0.461
3.0
3 1.11
2.5
1.23
2.8
# Points 277 1550 213 1597 277 1710
# Labs 8 9 6 8 8 10
Salicylate Trinder mg/dL

Mean 6.21 5.87 16.66 16.75 42.15 42.34
SD
CV
1 2.02
32.6
1.89
32.2
2 0.338
2.0
0.467
2.8
3 2.91
6.9
2.84
6.7
# Points 83 370 11 57 92 356
# Labs 5 6 2 2 6 6
Method Group • Trinder

Mean 6.21 5.87 16.66 16.75 42.15 42.34
SD
CV
1 2.02
32.6
1.89
32.2
2 0.338
2.0
0.467
2.8
3 2.91
6.9
2.84
6.7
# Points 83 370 11 57 92 356
# Labs 5 6 2 2 6 6
SHBG Chemiluminescence µg/dL

Mean 480.2 474.0 445.1 438.1 505.8 493.9
SD
CV
1 29.16
6.1
35.18
7.4
2 24.06
5.4
31.92
7.3
3 27.59
5.5
34.98
7.1
# Points 409 850 227 618 227 596
# Labs 11 12 9 10 9 9

Mean 561.6 557.0 439.2 442.7 −− −−
SD
CV
1 22.41
4.0
24.00
4.3
2 18.03
4.1
25.59
5.8
3 −−
−−
−−
−−
# Points 8 13 35 88 −− −−
# Labs 2 2 3 3
Dirui CS Series
Mean −− 531.8 −− −− −− −−
SD
CV
1 −−
−−
20.11
3.8
2 −−
−−
−−
−−
3 −−
−−
−−
−−
# Points −− 51 −− −− −− −−
# Labs 1
SHBG Chemiluminescence µg/dL

Siemens ADVIA Centaur Systems • SHBG, WHO 2nd IS, 08/266
Mean 436.0 436.0 398.9 398.9 450.1 450.1
SD
CV
1 20.70
4.7
20.70
4.7
23.33
5.8
2 23.33
5.8
3 28.76
6.4
28.76
6.4
# Points 27 27 20 20 21 21
# Labs 1 1 1 1 1 1

Mean 53.70 53.44 815.9 800.3 −− −−
SD
CV
1 2.87
5.4
3.26
6.1
2 46.34
5.7
48.56
6.1
3 −−
−−
−−
−−
# Points 23 206 23 206 −− −−
# Labs 1 1 1 1

Mean 507.1 510.6 458.3 482.4 512.1 542.2
SD
CV
1 17.70
3.5
20.64
4.0
2 12.20
2.7
37.72
7.8
3 75.24
14.7
110.2
20.3
# Points 3 6 2 6 3 6
# Labs 1 1 1 1 1 1

Mean 458.4 401.6 469.3 517.5 501.2 492.9
SD
CV
1 97.19
21.2
166.1
41.4
2 102.7
21.9
154.4
29.8
3 32.23
6.4
37.16
7.5
# Points 470 1153 307 938 251 623
# Labs 16 18 15 16 11 11
SHBG Chemiluminescence µg/mL

Mean 4.80 4.74 4.45 4.38 5.06 4.94
SD
CV
1 0.292
6.1
0.352
7.4
2 0.241
5.4
0.319
7.3
3 0.276
5.5
0.350
7.1
# Points 409 850 227 618 227 596
# Labs 11 12 9 10 9 9

Mean 5.62 5.57 4.39 4.43 −− −−
SD
CV
1 0.224
4.0
0.240
4.3
2 0.180
4.1
0.256
5.8
3 −−
−−
−−
−−
# Points 8 13 35 88 −− −−
# Labs 2 2 3 3
Dirui CS Series
Mean −− 5.32 −− −− −− −−
SD
CV
1 −−
−−
0.201
3.8
2 −−
−−
−−
−−
3 −−
−−
−−
−−
# Points −− 51 −− −− −− −−
# Labs 1
Siemens ADVIA Centaur Systems • SHBG, WHO 2nd IS, 08/266

Mean 4.36 4.36 3.99 3.99 4.50 4.50
SD
CV
1 0.207
4.7
0.207
4.7
0.233
5.8
2 0.233
5.8
3 0.288
6.4
0.288
6.4
# Points 27 27 20 20 21 21
# Labs 1 1 1 1 1 1

Mean 0.537 0.534 8.16 8.00 −− −−
SD
CV
1 0.029
5.4
0.033
6.1
2 0.463
5.7
0.486
6.1
3 −−
−−
−−
−−
# Points 23 206 23 206 −− −−
# Labs 1 1 1 1

Mean 5.07 5.11 4.58 4.82 5.12 5.42
SD
CV
1 0.177
3.5
0.206
4.0
2 0.122
2.7
0.377
7.8
3 0.752
14.7
1.10
20.3
# Points 3 6 2 6 3 6
# Labs 1 1 1 1 1 1
SHBG Chemiluminescence µg/mL

Mean 4.58 4.02 4.69 5.18 5.01 4.93
SD
CV
1 0.972
21.2
1.66
41.4
2 1.03
21.9
1.54
29.8
3 0.322
6.4
0.372
7.5
# Points 470 1153 307 938 251 623
# Labs 16 18 15 16 11 11
SHBG Electrochemiluminescence (ECL) µg/dL

Mean 433.1 446.8 380.1 394.6 427.5 462.1
SD
CV
1 16.87
3.9
32.10
7.2
2 24.07
6.3
34.52
8.7
3 21.97
5.1
27.70
6.0
# Points 24 57 63 283 27 191
# Labs 3 4 5 5 2 2

Mean 443.3 442.8 405.6 414.9 482.5 479.8
SD
CV
1 10.84
2.4
13.82
3.1
2 5.99
1.5
12.59
3.0
3 10.26
2.1
14.84
3.1
# Points 77 285 18 83 77 264
# Labs 4 7 2 5 4 7
Roche cobas e 402/801 • Roche Elecsys SHBG, REF 07258496

Mean −− −− 399.1 399.8 467.4 463.6
SD
CV
1 −−
−−
−−
−−
2
5.23
1.3
5.33
1.3
3 6.76
1.4
13.30
2.9
# Points −− −− 30 55 30 55
# Labs 1 1 1 1

Mean 440.9 443.4 389.4 399.3 468.0 471.4
SD
CV
1 13.19
3.0
18.18
4.1
2 21.38
5.5
29.96
7.5
3 24.86
5.3
22.24
4.7
# Points 101 342 111 421 134 510
# Labs 7 11 8 11 7 10
SHBG Electrochemiluminescence (ECL) µg/mL

Mean 4.33 4.47 3.80 3.95 4.28 4.62
SD
CV
1 0.169
3.9
0.321
7.2
2 0.241
6.3
0.345
8.7
3 0.220
5.1
0.277
6.0
# Points 24 57 63 283 27 191
# Labs 3 4 5 5 2 2

Mean 4.43 4.43 4.06 4.15 4.82 4.80
SD
CV
1 0.108
2.4
0.138
3.1
2 0.060
1.5
0.126
3.0
3 0.103
2.1
0.148
3.1
# Points 77 285 18 83 77 264
# Labs 4 7 2 5 4 7
Roche cobas e 402/801 • Roche Elecsys SHBG, REF 07258496

Mean −− −− 3.99 4.00 4.67 4.64
SD
CV
1 −−
−−
−−
−−
2
0.052
1.3
0.053
1.3
3 0.068
1.4
0.133
2.9
# Points −− −− 30 55 30 55
# Labs 1 1 1 1

Mean 4.41 4.43 3.89 3.99 4.68 4.71
SD
CV
1 0.132
3.0
0.182
4.1
2 0.214
5.5
0.300
7.5
3 0.249
5.3
0.222
4.7
# Points 101 342 111 421 134 510
# Labs 7 11 8 11 7 10
T3 Uptake/T Uptake Chemiluminescence % Uptake

Mean 28.49 28.76 31.16 31.31 29.84 29.92
SD
CV
1 0.965
3.4
1.12
3.9
2 0.941
3.0
1.14
3.6
3 0.820
2.7
1.04
3.5
# Points 31 193 30 193 30 192
# Labs 1 1 1 1 1 1

Mean 45.55 45.20 51.05 50.23 53.94 53.02
SD
CV
1 2.73
6.0
2.59
5.7
2 3.09
6.1
2.68
5.3
3 3.13
5.8
2.91
5.5
# Points 177 598 148 453 174 595
# Labs 5 5 4 4 5 5

Mean −− 0.767 −− 0.577 −− 0.522
SD
CV
1 −−
−−
0.022
2.9
2 −−
−−
0.012
2.2
3 −−
−−
0.011
2.2
# Points −− 34 −− 34 −− 34
# Labs 1 1 1

Mean 43.01 39.53 47.70 42.38 50.40 45.44
SD
CV
1 6.60
15.3
10.85
27.4
2 7.99
16.7
12.98
30.6
3 9.04
17.9
13.71
30.2
# Points 208 825 178 680 204 821
# Labs 6 7 5 6 6 7
T3 Uptake/T Uptake Chemiluminescence T Uptake Unit

Mean 0.970 0.921 0.880 0.817 0.912 0.868
SD
CV
1 0.033
3.4
0.048
5.2
2 0.028
3.2
0.041
5.0
3 0.022
2.4
0.037
4.3
# Points 7 90 2 78 6 103
# Labs 1 2 1 2 1 2

Mean 0.970 0.921 0.880 0.817 0.912 0.868
SD
CV
1 0.033
3.4
0.048
5.2
2 0.028
3.2
0.041
5.0
3 0.022
2.4
0.037
4.3
# Points 7 90 2 78 6 103
# Labs 1 2 1 2 1 2
T3 Uptake/T Uptake EIA % Uptake

Mean 31.46 32.33 38.65 39.51 42.13 42.88
SD
CV
1 0.530
1.7
1.50
4.6
2 0.724
1.9
1.48
3.8
3 0.700
1.7
1.36
3.2
# Points 48 229 48 229 48 229
# Labs 2 2 2 2 2 2

Mean 31.46 32.33 38.65 39.51 42.13 42.88
SD
CV
1 0.530
1.7
1.50
4.6
2 0.724
1.9
1.48
3.8
3 0.700
1.7
1.36
3.2
# Points 48 229 48 229 48 229
# Labs 2 2 2 2 2 2
T3 Uptake/T Uptake EIA T Uptake Unit

Mean 32.77 34.09 38.62 39.22 −− −−
SD
CV
1 5.04
15.4
3.86
11.3
2 0.833
2.2
1.01
2.6
3 −−
−−
−−
−−
# Points 32 63 32 63 −− −−
# Labs 2 2 2 2
T3 Uptake/T Uptake EIA T Uptake Unit

Mean 32.77 34.09 38.62 39.22 −− −−
SD
CV
1 5.04
15.4
3.86
11.3
2 0.833
2.2
1.01
2.6
3 −−
−−
−−
−−
# Points 32 63 32 63 −− −−
# Labs 2 2 2 2
T3 Uptake/T Uptake Electrochemiluminescence (ECL) % Uptake

Mean 32.34 33.08 −− −− 48.28 49.45
SD
CV
1 0.476
1.5
1.13
3.4
2 −−
−−
−−
−−
3 0.800
1.7
1.98
4.0
# Points 32 133 −− −− 34 133
# Labs 1 1 1 1

Mean 32.34 33.08 −− −− 48.28 49.45
SD
CV
1 0.476
1.5
1.13
3.4
2 −−
−−
−−
−−
3 0.800
1.7
1.98
4.0
# Points 32 133 −− −− 34 133
# Labs 1 1 1 1
T3 Uptake/T Uptake Electrochemiluminescence (ECL) TBI

Roche cobas e 402/801 • Roche Elecsys T−Uptake, REF 07028105
Mean 0.936 0.885 0.545 0.455 −− −−
SD
CV
1 0.009
1.0
0.061
6.9
2
0.010
1.9
0.095
20.9
3 −−
−−
−−
−−
# Points 11 31 11 31 −− −−
# Labs 1 1 1 1

Mean 0.936 0.885 0.545 0.455 −− −−
SD
CV
1 0.009
1.0
0.061
6.9
2 0.010
1.9
0.095
20.9
3 −−
−−
−−
−−
# Points 11 31 11 31 −− −−
# Labs 1 1 1 1
T3, Free Chemiluminescence pg/mL

Abbott Alinity i
Mean 2.59 2.56 7.03 7.01 12.66 12.64
SD
CV
1 0.165
6.4
0.160
6.2
2 0.329
4.7
0.336
4.8
3 0.885
7.0
0.893
7.1
# Points 1628 4876 1575 4733 1610 4766
# Labs 53 57 51 55 55 58
Abbott Alinity i • Abbott ARCHITECT Thyroid, 6 point calibration

Mean 2.71 2.60 6.95 6.88 13.10 12.96
SD
CV
1 0.069
2.5
0.128
4.9
20.161
2.3
0.222
3.2
3 0.482
3.7
0.532
4.1
# Points 16 75 10 62 22 99
# Labs 1 1 1 1 1 1

Mean 2.65 2.62 6.97 6.96 12.66 12.57
SD
CV
1 0.181
6.8
0.186
7.1
2 0.297
4.3
0.355
5.1
3 0.876
6.9
0.816
6.5
# Points 694 2278 577 1874 596 2021
# Labs 20 25 14 18 16 20
Abbott ARCHITECT (c, i, ci models) • Abbott ARCHITECT Thyroid, 6 point calibration

Mean 2.65 2.54 6.89 6.80 12.42 12.85
SD
CV
1 0.176
6.6
0.193
7.6
2
0.317
4.6
0.348
5.1
3 0.911
7.3
1.10
8.6
# Points 239 536 218 372 116 368
# Labs 14 17 13 15 11 13

Mean 2.73 2.66 7.34 7.30 13.69 13.46
SD
CV
1 0.117
4.3
0.114
4.3
2
0.271
3.7
0.256
3.5
3 0.677
4.9
0.688
5.1
# Points 62 312 62 286 62 341
# Labs 1 1 1 1 1 1

Mean 2.80 2.70 7.33 7.23 −− −−
SD
CV
1 0.121
4.3
0.175
6.5
2 0.238
3.2
0.364
5.0
3 −−
−−
−−
−−
# Points 29 88 28 86 −− −−
# Labs 1 1 1 1

Mean 3.65 3.97 10.76 10.28 25.49 24.68
SD
CV
1 0.766
21.0
0.704
17.7
2 2.00
18.6
2.12
20.6
3 5.06
19.8
5.50
22.3
# Points 13 33 15 58 14 47
# Labs 2 2 3 3 2 3

Mean 2.57 2.55 6.35 6.24 10.01 9.78
SD
CV
1 0.163
6.3
0.160
6.3
2 0.412
6.5
0.354
5.7
3 0.596
6.0
0.608
6.2
# Points 231 949 271 996 247 957
# Labs 14 18 13 14 14 15

Mean 2.44 2.43 5.54 5.53 8.40 8.37
SD
CV
1 0.225
9.2
0.229
9.4
2 0.405
7.3
0.431
7.8
3 0.661
7.9
0.711
8.5
# Points 628 2801 827 3347 852 3221
# Labs 34 47 39 52 40 52
DiaSorin LIAISON/XL
Mean 28.95 28.95 103.6 103.6 −− −−
SD
CV
1 1.51
5.2
1.51
5.2
2 5.79
5.6
5.79
5.6
3 −−
−−
−−
−−
# Points 8 8 9 9 −− −−
# Labs 1 1 1 1
DiaSorin LIAISON/XL • DiaSorin LIAISON T3, REF 311311

Mean 2.45 2.66 9.72 10.13 −− −−
SD
CV
1 0.060
2.5
0.166
6.3
2 0.533
5.5
0.473
4.7
3 −−
−−
−−
−−
# Points 4 13 4 13 −− −−
# Labs 1 1 1 1
Mindray CL Series
Mean 2.58 3.40 7.50 8.62 12.08 12.07
SD
CV
1 0.130
5.0
0.671
19.7
2 0.433
5.8
1.65
19.2
3 0.245
2.0
0.214
1.8
# Points 34 115 58 403 20 149
# Labs 2 3 4 6 3 3

Mean 2.67 2.83 7.90 7.85 −− −−
SD
CV
1 0.131
4.9
0.173
6.1
2 0.143
1.8
0.250
3.2
3 −−
−−
−−
−−
# Points 13 35 14 36 −− −−
# Labs 1 1 1 1

Mean 2.97 2.94 7.61 7.53 11.92 12.06
SD
CV
1 0.197
6.6
0.183
6.2
2 0.342
4.5
0.570
7.6
3 0.932
7.8
0.874
7.2
# Points 108 313 123 348 93 315
# Labs 4 4 5 5 4 6

Mean 2.94 2.94 7.55 7.55 12.08 12.09
SD
CV
1 0.122
4.1
0.118
4.0
2 0.383
5.1
0.324
4.3
3 0.686
5.7
0.709
5.9
# Points 725 2505 748 2351 626 1859
# Labs 35 41 34 40 32 34

Mean 2.92 2.94 7.68 7.66 12.58 12.78
SD
CV
1 0.108
3.7
0.113
3.8
2 0.329
4.3
0.331
4.3
3 0.602
4.8
0.727
5.7
# Points 758 2811 732 2575 650 2376
# Labs 25 25 21 21 21 22

Mean 2.42 2.39 8.60 8.61 15.30 15.32
SD
CV
1 0.109
4.5
0.122
5.1
2 0.175
2.0
0.235
2.7
3 0.274
1.8
0.422
2.8
# Points 123 496 119 327 86 465
# Labs 5 5 5 5 4 4

Mean 2.37 2.32 8.48 8.40 14.97 14.91
SD
CV
1 0.118
5.0
0.140
6.0
2 0.197
2.3
0.232
2.8
3 0.274
1.8
0.281
1.9
# Points 23 33 23 33 23 33
# Labs 1 1 1 1 1 1

Mean 2.97 2.91 6.53 6.51 10.22 10.23
SD
CV
1 0.446
15.0
0.442
15.2
2 0.630
9.7
0.599
9.2
3 0.905
8.9
0.804
7.9
# Points 59 166 58 165 59 166
# Labs 5 5 5 5 5 5
Snibe MAGLUMI
Mean 2.92 2.92 8.84 8.79 16.74 16.70
SD
CV
1 0.147
5.1
0.178
6.1
2 0.484
5.5
0.451
5.1
3 0.494
3.0
1.30
7.8
# Points 5 19 11 19 12 20
# Labs 1 1 1 1 1 1

Mean 7.17 4.88 16.34 11.37 17.94 18.33
SD
CV
1 10.05
140.2
6.84
140.2
2 23.70
145.1
13.66
120.2
3 0.709
4.0
1.88
10.3
# Points 32 80 57 183 53 178
# Labs 2 6 4 7 3 6

Mean 4.44 4.50 16.66 16.96 22.75 22.75
SD
CV
1 0.351
7.9
0.425
9.5
2 0.771
4.6
1.24
7.3
3 0.026
0.1
0.027
0.1
# Points 715 2763 755 2942 136 528
# Labs 28 31 29 32 9 11
YHLO iFlash 3000

Mean −− −− 8.18 8.18 13.19 13.19
SD
CV
1 −−
−−
−−
−−
2 0.201
2.5
0.201
2.5
3 0.351
2.7
0.351
2.7
# Points −− −− 39 39 39 39
# Labs 1 1 1 1

Mean 2.95 2.93 8.38 8.42 12.13 12.10
SD
CV
1 1.38
46.6
0.959
32.7
2 5.41
64.5
4.32
51.3
3 2.70
22.2
2.88
23.8
# Points 6085 20993 6271 20971 5254 17607
# Labs 250 293 248 286 223 256
T3, Free EIA pg/mL

Mean 2.19 2.19 7.04 7.04 12.06 12.06
SD
CV
1 0.206
9.4
0.206
9.4
2 0.647
9.2
0.647
9.2
3 0.683
5.7
0.683
5.7
# Points 10 10 10 10 10 10
# Labs 1 1 1 1 1 1
Roche cobas c 303/503 • Roche Elecsys FT3 III, REF 09005811

Mean 2.93 2.90 8.61 8.58 15.09 15.13
SD
CV
1 0.078
2.7
0.099
3.4
0.165
1.9
2 0.182
2.1
3 0.266
1.8
0.348
2.3
# Points 27 66 27 68 27 68
# Labs 1 1 1 1 1 1
Tosoh AIA Models

Mean −− −− −− 11.15 −− −−
SD
CV
1 −−
−−
−−
−−
2 −−
−−
0.237
2.1
3 −−
−−
−−
−−
# Points −− −− −− 3 −− −−
# Labs 1

Mean 2.73 2.81 8.19 8.49 14.27 14.73
SD
CV
1 0.353
12.9
0.267
9.5
2 0.790
9.7
0.782
9.2
3 1.42
10.0
1.11
7.5
# Points 37 76 37 81 37 78
# Labs 2 2 2 3 2 2
T3, Free Electrochemiluminescence (ECL) pg/mL

Mindray CL Series
Mean 2.66 2.62 −− −− 12.45 12.37
SD
CV
1 0.039
1.5
0.047
1.8
2 −−
−−
−−
−−
3 0.188
1.5
0.200
1.6
# Points 23 140 −− −− 23 139
# Labs 1 1 1 1

Mean 2.86 2.88 8.59 8.66 15.28 15.38
SD
CV
1 0.225
7.9
0.219
7.6
2 0.400
4.7
0.414
4.8
3 0.584
3.8
0.767
5.0
# Points 521 1445 653 2108 536 1741
# Labs 31 38 35 43 30 36

Mean 2.96 2.98 8.62 8.88 15.60 15.70
SD
CV
1 0.087
2.9
0.098
3.3
2 0.252
2.9
0.333
3.7
3 0.480
3.1
0.448
2.9
# Points 67 131 27 88 69 127
# Labs 3 4 1 2 3 4
Roche cobas 6000/8000/c 311 • Roche Elecsys FT3 III, REF 09005811
Mean 2.91 2.88 8.51 8.51 14.98 15.03
SD
CV
1 0.071
2.4
0.071
2.5
0.140
1.6
2 0.116
1.4
3 0.162
1.1
0.168
1.1
# Points 4 6 4 6 4 6
# Labs 1 1 1 1 1 1
Mean −− 2.86 −− 8.48 −− 15.38
SD
CV
1 −−
−−
0.109
3.8
−−
−−
2 0.281
3.3
3 −−
−−
0.284
1.8
# Points −− 57 −− 24 −− 3
# Labs 2 1 1

Mean 3.04 3.05 8.80 8.79 15.22 15.34
SD
CV
1 0.188
6.2
0.186
6.1
2 0.424
4.8
0.419
4.8
3 0.678
4.5
0.645
4.2
# Points 1299 4210 1062 3462 345 1472
# Labs 33 35 25 27 17 19

Roche cobas e 402/801 • Roche Elecsys FT3 III, REF 09005811
Mean 3.01 2.96 8.66 8.59 15.44 15.18
SD
CV
1 0.108
3.6
0.117
3.9
2
0.216
2.5
0.207
2.4
3 0.350
2.3
0.397
2.6
# Points 64 137 64 138 32 82
# Labs 2 2 2 2 1 1

Mean 2.97 2.92 8.49 8.44 15.27 15.06
SD
CV
1 0.159
5.3
0.150
5.1
2
0.319
3.8
0.297
3.5
3 0.315
2.1
0.377
2.5
# Points 137 539 71 287 96 388
# Labs 9 9 7 7 7 7

Mean 2.89 2.99 9.02 8.99 14.81 15.25
SD
CV
1 0.213
7.3
0.180
6.0
2
0.269
3.0
0.213
2.4
3 0.271
1.8
0.522
3.4
# Points 27 59 12 28 15 31
# Labs 1 1 1 1 1 1
Roche cobas u 601

Mean 2.85 2.84 8.53 8.52 15.49 15.38
SD
CV
1 0.117
4.1
0.105
3.7
2 0.234
2.7
0.191
2.2
3 0.364
2.3
0.354
2.3
# Points 18 38 17 38 18 39
# Labs 1 1 1 1 1 1

Mean 2.96 2.96 8.66 8.62 15.37 15.37
SD
CV
1 0.237
8.0
0.259
8.7
2 0.474
5.5
0.521
6.0
3 0.773
5.0
0.832
5.4
# Points 689 1904 739 2075 632 1629
# Labs 42 47 47 53 43 47
Roche Elecsys / cobas e 411 Series • 3rd Generation

Mean 2.76 2.77 8.17 8.29 −− −−
SD
CV
1 0.158
5.7
0.178
6.4
2 0.312
3.8
0.439
5.3
3 −−
−−
−−
−−
# Points 28 93 25 88 −− −−
# Labs 1 1 1 1
Roche Elecsys / cobas e 411 Series • Roche Elecsys FT3 III, REF 09005803
Mean −− 2.77 −− 8.20 −− 14.38
SD
CV
1 −−
−−
0.218
7.9
2 −−
−−
0.319
3.9
3 −−
−−
0.472
3.3
# Points −− 58 −− 54 −− 59
# Labs 1 1 1

Mean 2.97 2.98 8.69 8.69 15.28 15.27
SD
CV
1 0.216
7.2
0.220
7.4
2 0.436
5.0
0.450
5.2
3 0.734
4.8
0.857
5.6
# Points 2877 8817 2674 8396 1770 5716
# Labs 125 143 121 140 105 120
T3, Free FIA pg/mL

Mean 2.40 2.37 7.79 7.29 12.40 12.46
SD
CV
1 0.318
13.2
0.252
10.6
2 0.579
7.4
0.481
6.6
3 0.867
7.0
0.867
7.0
# Points 8 21 6 37 17 35
# Labs 2 2 2 3 3 3

Mean 2.40 2.37 7.79 7.29 12.40 12.46
SD
CV
1 0.318
13.2
0.252
10.6
2 0.579
7.4
0.481
6.6
3 0.867
7.0
0.867
7.0
# Points 8 21 6 37 17 35
# Labs 2 2 2 3 3 3
T3, Reverse Chemiluminescence ng/mL

Mean 0.370 0.393 −− −− 2.29 2.42
SD
CV
1 0.020
5.4
0.032
8.1
2 −−
−−
−−
−−
3 0.190
8.3
0.254
10.5
# Points 26 59 −− −− 26 59
# Labs 1 1 1 1

Mean 0.370 0.393 −− −− 2.29 2.42
SD
CV
1 0.020
5.4
0.032
8.1
2 −−
−−
−−
−−
3 0.190
8.3
0.254
10.5
# Points 26 59 −− −− 26 59
# Labs 1 1 1 1
T3, Total Chemiluminescence ng/dL

Abbott ARCHITECT i1000/ci4100 Series
Mean 80.65 78.16 203.5 199.1 316.2 300.8
SD
CV
1 3.61
4.5
15.05
19.3
2 9.05
4.4
27.28
13.7
3 17.22
5.4
42.50
14.1
# Points 181 726 200 731 179 541
# Labs 9 12 10 13 10 12

Mean 81.30 81.12 202.4 202.2 315.7 314.2
SD
CV
1 4.52
5.6
4.21
5.2
2 9.48
4.7
9.69
4.8
3 19.08
6.0
18.86
6.0
# Points 1638 5219 1582 4895 1499 4987
# Labs 62 73 58 68 58 69
Abbott ARCHITECT/Alinity (c, i, ci models) • Abbott ARCHITECT Thyroid, 6 point calibration

Mean 82.17 80.86 204.2 200.7 315.1 310.6
SD
CV
1 1.54
1.9
2.54
3.1
2
6.60
3.2
6.00
3.0
3 13.24
4.2
12.76
4.1
# Points 29 212 32 197 59 306
# Labs 2 2 2 2 2 2

Mean 80.35 81.08 203.2 204.2 311.8 318.4
SD
CV
1 2.85
3.5
3.62
4.5
2
4.86
2.4
5.74
2.8
3 10.51
3.4
14.56
4.6
# Points 37 224 37 199 37 251
# Labs 1 1 1 1 1 1

Mean −− −− 240.5 209.5 421.7 354.5
SD
CV
1 −−
−−
−−
−−
2 25.05
10.4
77.89
37.2
3 52.02
12.3
124.7
35.2
# Points −− −− 14 54 16 63
# Labs 1 2 1 2

Mean 93.27 96.58 208.0 210.9 334.9 341.5
SD
CV
1 9.48
10.2
11.88
12.3
2 14.82
7.1
16.33
7.7
3 25.02
7.5
32.75
9.6
# Points 317 1057 317 1042 279 947
# Labs 16 18 15 16 17 18

Mean 91.58 91.33 206.5 204.8 337.0 337.4
SD
CV
1 9.85
10.8
11.04
12.1
2 16.41
7.9
17.94
8.8
3 27.69
8.2
29.78
8.8
# Points 695 2783 871 3310 902 3431
# Labs 34 45 39 50 41 51
Dirui CS Series
Mean −− 78.87 −− 173.0 −− −−
SD
CV
1 −−
−−
5.87
7.4
2 −−
−−
9.19
5.3
3 −−
−−
−−
−−
# Points −− 70 −− 70 −− −−
# Labs 1 1
T3, Total Chemiluminescence ng/dL

Mindray CL Series
Mean 75.11 106.3 90.03 174.3 287.3 289.0
SD
CV
1 1.47
2.0
19.58
18.4
2 90.15
100.1
95.10
54.6
3 10.04
3.5
8.07
2.8
# Points 13 101 26 251 20 36
# Labs 1 2 2 4 3 3

Mean 1627 916.4 82.43 742.7 6754 3056
SD
CV
1 3286
202.0
2549
278.2
2 109.8
133.2
3674
494.6
3 15027
222.5
10455
342.1
# Points 78 189 91 228 97 221
# Labs 4 4 4 5 5 5

Mean 92.47 93.00 227.0 228.5 362.2 368.4
SD
CV
1 8.47
9.2
8.59
9.2
2 15.06
6.6
15.30
6.7
3 19.12
5.3
22.63
6.1
# Points 751 2615 725 2485 643 1950
# Labs 31 38 30 37 30 34

Mean 98.73 101.3 240.0 243.1 374.0 382.0
SD
CV
1 10.82
11.0
10.90
10.8
2 16.63
6.9
17.86
7.3
3 22.25
5.9
24.25
6.3
# Points 482 1692 474 1483 442 1517
# Labs 19 19 15 15 16 16

Mean 68.90 68.02 201.5 200.3 360.5 359.1
SD
CV
1 5.04
7.3
4.85
7.1
2 11.41
5.7
11.87
5.9
3 21.07
5.8
21.70
6.0
# Points 25 74 25 75 25 75
# Labs 3 3 3 3 3 3

Mean 99.21 96.17 206.2 202.1 320.9 318.2
SD
CV
1 11.08
11.2
13.19
13.7
2 9.01
4.4
14.60
7.2
3 8.35
2.6
22.56
7.1
# Points 48 85 81 264 69 186
# Labs 2 4 4 6 3 5
Snibe MAGLUMI Series • Snibe MAGLUMI T3 REF 130X03003M

Mean −− 100.8 −− 194.8 −− 314.2
SD
CV
1 −−
−−
8.38
8.3
−−
−−
2 4.86
2.5
3 −−
−−
13.77
4.4
# Points −− 4 −− 4 −− 4
# Labs 1 1 1

Mean 100.5 99.09 241.6 238.2 409.9 401.8
SD
CV
1 5.65
5.6
5.94
6.0
2 12.08
5.0
14.33
6.0
3 22.71
5.5
23.97
6.0
# Points 1066 5199 1012 4955 1077 5104
# Labs 48 53 46 51 47 51
YHLO iFlash 3000

Mean −− −− 249.0 249.0 −− −−
SD
CV
1 −−
−−
−−
−−
2 7.00
2.8
7.00
2.8
3 −−
−−
−−
−−
# Points −− −− 25 25 −− −−
# Labs 1 1

Mean 113.1 99.19 215.0 223.9 468.1 384.6
SD
CV
1 436.4
386.0
259.8
261.9
2 32.39
15.1
395.5
176.6
3 2196
469.2
1152
299.4
# Points 5323 20026 5475 20069 5307 19368
# Labs 231 275 230 275 236 272
T3, Total Chemiluminescence ng/mL

Abbott ARCHITECT i1000/ci4100 Series
Mean 0.807 0.782 2.03 1.99 3.16 3.01
SD
CV
1 0.036
4.5
0.151
19.3
2 0.091
4.4
0.273
13.7
3 0.172
5.4
0.425
14.1
# Points 181 726 200 731 179 541
# Labs 9 12 10 13 10 12

Mean 0.813 0.811 2.02 2.02 3.16 3.14
SD
CV
1 0.045
5.6
0.042
5.2
2 0.095
4.7
0.097
4.8
3 0.191
6.0
0.189
6.0
# Points 1638 5219 1582 4895 1499 4987
# Labs 62 73 58 68 58 69

Mean 0.822 0.809 2.04 2.01 3.15 3.11
SD
CV
1 0.015
1.9
0.025
3.1
2
0.066
3.2
0.060
3.0
3 0.132
4.2
0.128
4.1
# Points 29 212 32 197 59 306
# Labs 2 2 2 2 2 2

Mean 0.804 0.811 2.03 2.04 3.12 3.18
SD
CV
1 0.029
3.5
0.036
4.5
2
0.049
2.4
0.057
2.8
3 0.105
3.4
0.146
4.6
# Points 37 224 37 199 37 251
# Labs 1 1 1 1 1 1

Mean −− −− 2.41 2.09 4.22 3.55
SD
CV
1 −−
−−
−−
−−
2 0.251
10.4
0.779
37.2
3 0.520
12.3
1.25
35.2
# Points −− −− 14 54 16 63
# Labs 1 2 1 2

Mean 0.933 0.966 2.08 2.11 3.35 3.41
SD
CV
1 0.095
10.2
0.119
12.3
2 0.148
7.1
0.163
7.7
3 0.250
7.5
0.328
9.6
# Points 317 1057 317 1042 279 947
# Labs 16 18 15 16 17 18

Mean 0.916 0.913 2.07 2.05 3.37 3.37
SD
CV
1 0.099
10.8
0.110
12.1
2 0.164
7.9
0.179
8.8
3 0.277
8.2
0.298
8.8
# Points 695 2783 871 3310 902 3431
# Labs 34 45 39 50 41 51
Dirui CS Series
Mean −− 0.789 −− 1.73 −− −−
SD
CV
1 −−
−−
0.059
7.4
2 −−
−−
0.092
5.3
3 −−
−−
−−
−−
# Points −− 70 −− 70 −− −−
# Labs 1 1
Mindray CL Series
Mean 0.751 1.06 0.900 1.74 2.87 2.89
SD
CV
1 0.015
2.0
0.196
18.4
2 0.901
100.1
0.951
54.6
3 0.100
3.5
0.081
2.8
# Points 13 101 26 251 20 36
# Labs 1 2 2 4 3 3

Mean 16.27 9.16 0.824 7.43 67.54 30.56
SD
CV
1 32.86
202.0
25.49
278.2
2 1.10
133.2
36.74
494.6
3 150.3
222.5
104.5
342.1
# Points 78 189 91 228 97 221
# Labs 4 4 4 5 5 5
T3, Total Chemiluminescence ng/mL

Mean 0.925 0.930 2.27 2.29 3.62 3.68
SD
CV
1 0.085
9.2
0.086
9.2
2 0.151
6.6
0.153
6.7
3 0.191
5.3
0.226
6.1
# Points 751 2615 725 2485 643 1950
# Labs 31 38 30 37 30 34

Mean 0.987 1.01 2.40 2.43 3.74 3.82
SD
CV
1 0.108
11.0
0.109
10.8
2 0.166
6.9
0.179
7.3
3 0.222
5.9
0.242
6.3
# Points 482 1692 474 1483 442 1517
# Labs 19 19 15 15 16 16

Mean 0.689 0.680 2.02 2.00 3.61 3.59
SD
CV
1 0.050
7.3
0.049
7.1
2 0.114
5.7
0.119
5.9
3 0.211
5.8
0.217
6.0
# Points 25 74 25 75 25 75
# Labs 3 3 3 3 3 3

Mean 0.992 0.962 2.06 2.02 3.21 3.18
SD
CV
1 0.111
11.2
0.132
13.7
2 0.090
4.4
0.146
7.2
3 0.083
2.6
0.226
7.1
# Points 48 85 81 264 69 186
# Labs 2 4 4 6 3 5
Snibe MAGLUMI Series • Snibe MAGLUMI T3 REF 130X03003M

Mean −− 1.01 −− 1.95 −− 3.14
SD
CV
1 −−
−−
0.084
8.3
−−
−−
2 0.049
2.5
3 −−
−−
0.138
4.4
# Points −− 4 −− 4 −− 4
# Labs 1 1 1

Mean 1.00 0.991 2.42 2.38 4.10 4.02
SD
CV
1 0.057
5.6
0.059
6.0
2 0.121
5.0
0.143
6.0
3 0.227
5.5
0.240
6.0
# Points 1066 5199 1012 4955 1077 5104
# Labs 48 53 46 51 47 51
YHLO iFlash 3000

Mean −− −− 2.49 2.49 −− −−
SD
CV
1 −−
−−
−−
−−
2 0.070
2.8
0.070
2.8
3 −−
−−
−−
−−
# Points −− −− 25 25 −− −−
# Labs 1 1

Mean 1.13 0.992 2.15 2.24 4.68 3.85
SD
CV
1 4.36
386.0
2.60
261.9
2 0.324
15.1
3.96
176.6
3 21.96
469.2
11.52
299.4
# Points 5323 20026 5475 20069 5307 19368
# Labs 231 275 230 275 236 272
T3, Total EIA ng/dL

Mean 122.5 122.5 348.0 348.0 520.8 520.8
SD
CV
1 9.09
7.4
9.09
7.4
2 8.10
2.3
8.10
2.3
3 17.62
3.4
17.62
3.4
# Points 6 6 6 6 6 6
# Labs 1 1 1 1 1 1
Roche cobas c 303/503 • Roche Elecsys T3, REF 09007733

Mean 106.0 103.2 249.7 244.3 379.1 369.3
SD
CV
1 2.60
2.5
3.89
3.8
2
5.40
2.2
8.06
3.3
3 7.32
1.9
12.23
3.3
# Points 27 66 27 66 27 66
# Labs 1 1 1 1 1 1
T3, Total EIA ng/dL

Tosoh AIA Models
Mean 92.43 93.50 215.3 216.0 343.4 345.1
SD
CV
1 2.92
3.2
3.41
3.6
2 6.56
3.0
8.20
3.8
3 9.79
2.9
11.74
3.4
# Points 23 74 27 80 26 78
# Labs 1 2 2 3 2 3

Mean 102.2 99.10 244.1 233.5 377.8 362.7
SD
CV
1 10.30
10.1
7.87
7.9
2 39.09
16.0
28.27
12.1
3 52.35
13.9
36.55
10.1
# Points 56 146 60 152 59 150
# Labs 3 4 4 5 4 5
T3, Total EIA ng/mL

Mean 1.23 1.23 3.48 3.48 5.21 5.21
SD
CV
1 0.091
7.4
0.091
7.4
2 0.081
2.3
0.081
2.3
3 0.176
3.4
0.176
3.4
# Points 6 6 6 6 6 6
# Labs 1 1 1 1 1 1

Mean 1.06 1.03 2.50 2.44 3.79 3.69
SD
CV
1 0.026
2.5
0.039
3.8
0.054
2.2
2 0.081
3.3
3 0.073
1.9
0.122
3.3
# Points 27 66 27 66 27 66
# Labs 1 1 1 1 1 1
Tosoh AIA Models

Mean 0.924 0.935 2.15 2.16 3.43 3.45
SD
CV
1 0.029
3.2
0.034
3.6
2 0.066
3.0
0.082
3.8
3 0.098
2.9
0.117
3.4
# Points 23 74 27 80 26 78
# Labs 1 2 2 3 2 3

Mean 1.02 0.991 2.44 2.34 3.78 3.63
SD
CV
1 0.103
10.1
0.079
7.9
2 0.391
16.0
0.283
12.1
3 0.523
13.9
0.365
10.1
# Points 56 146 60 152 59 150
# Labs 3 4 4 5 4 5
T3, Total Electrochemiluminescence (ECL) ng/dL

Mindray CL Series
Mean 81.00 83.20 −− −− 299.0 309.6
SD
CV
1 2.00
2.5
3.34
4.0
2 −−
−−
−−
−−
3 4.00
1.3
12.50
4.0
# Points 23 140 −− −− 23 139
# Labs 1 1 1 1

Mean 108.0 107.4 247.9 246.2 378.2 376.6
SD
CV
1 6.70
6.2
6.94
6.5
2 14.25
5.7
13.71
5.6
3 21.64
5.7
21.64
5.7
# Points 606 2811 706 3053 660 2665
# Labs 36 43 39 45 37 40

Mean 110.5 108.0 261.6 258.4 396.3 390.1
SD
CV
1 5.47
5.0
6.48
6.0
2 14.37
5.5
14.56
5.6
3 12.53
3.2
16.47
4.2
# Points 471 1503 282 855 477 1692
# Labs 19 25 12 18 18 24
T3, Total Electrochemiluminescence (ECL) ng/dL

Roche cobas e 402/801 • Roche Elecsys T3, REF 07027869
Mean 107.7 106.1 254.9 253.0 381.6 378.2
SD
CV
1 7.38
6.9
6.62
6.2
2
14.05
5.5
12.39
4.9
3 14.41
3.8
14.99
4.0
# Points 281 850 177 464 213 583
# Labs 11 11 8 8 9 9

Mean 109.3 108.1 257.4 254.7 389.3 386.4
SD
CV
1 3.62
3.3
4.98
4.6
2
7.70
3.0
8.83
3.5
3 8.71
2.2
10.67
2.8
# Points 173 480 135 373 129 316
# Labs 8 8 6 6 6 6
Mean 111.0 106.0 262.2 255.3 400.7 384.4
SD
CV
1 2.56
2.3
4.74
4.5
28.63
3.3
7.67
3.0
3 15.36
3.8
15.10
3.9
# Points 22 108 22 108 22 108
# Labs 1 1 1 1 1 1

Mean 107.9 106.9 240.1 1101 372.1 1805
SD
CV
1 10.42
9.7
12.19
11.4
2 30.35
12.6
4567
414.9
3 48.57
13.1
7241
401.2
# Points 649 2128 614 2232 560 1836
# Labs 37 41 36 43 35 43

Mean 108.3 106.8 248.9 517.9 381.1 736.4
SD
CV
1 8.19
7.6
9.00
8.4
2 21.85
8.8
2593
500.7
3 31.71
8.3
3673
498.8
# Points 2225 8020 1936 7085 2084 7339
# Labs 113 130 102 121 107 124
T3, Total Electrochemiluminescence (ECL) ng/mL

Mindray CL Series
Mean 0.810 0.832 −− −− 2.99 3.10
SD
CV
1 0.020
2.5
0.033
4.0
2 −−
−−
−−
−−
3 0.040
1.3
0.125
4.0
# Points 23 140 −− −− 23 139
# Labs 1 1 1 1

Mean 1.08 1.07 2.48 2.46 3.78 3.77
SD
CV
1 0.067
6.2
0.069
6.5
2 0.142
5.7
0.137
5.6
3 0.216
5.7
0.216
5.7
# Points 606 2811 706 3053 660 2665
# Labs 36 43 39 45 37 40

Mean 1.11 1.08 2.62 2.58 3.96 3.90
SD
CV
1 0.055
5.0
0.065
6.0
2 0.144
5.5
0.146
5.6
3 0.125
3.2
0.165
4.2
# Points 471 1503 282 855 477 1692
# Labs 19 25 12 18 18 24

Mean 1.08 1.06 2.55 2.53 3.82 3.78
SD
CV
1 0.074
6.9
0.066
6.2
2
0.141
5.5
0.124
4.9
3 0.144
3.8
0.150
4.0
# Points 281 850 177 464 213 583
# Labs 11 11 8 8 9 9

Mean 1.09 1.08 2.57 2.55 3.89 3.86
SD
CV
1 0.036
3.3
0.050
4.6
2
0.077
3.0
0.088
3.5
3 0.087
2.2
0.107
2.8
# Points 173 480 135 373 129 316
# Labs 8 8 6 6 6 6
T3, Total Electrochemiluminescence (ECL) ng/mL

Mean 1.11 1.06 2.62 2.55 4.01 3.84
SD
CV
1 0.026
2.3
0.047
4.5
0.086
3.3
2
0.077
3.0
3 0.154
3.8
0.151
3.9
# Points 22 108 22 108 22 108
# Labs 1 1 1 1 1 1

Mean 1.08 1.07 2.40 11.01 3.72 18.05
SD
CV
1 0.104
9.7
0.122
11.4
2 0.304
12.6
45.67
414.9
3 0.486
13.1
72.41
401.2
# Points 649 2128 614 2232 560 1836
# Labs 37 41 36 43 35 43

Mean 1.08 1.07 2.49 5.18 3.81 7.36
SD
CV
1 0.082
7.6
0.090
8.4
2 0.219
8.8
25.93
500.7
3 0.317
8.3
36.73
498.8
# Points 2225 8020 1936 7085 2084 7339
# Labs 113 130 102 121 107 124
T3, Total FIA ng/dL

Mean 78.83 78.12 223.0 214.3 348.0 345.5
SD
CV
1 8.59
10.9
7.41
9.5
2 12.71
5.7
22.93
10.7
3 19.27
5.5
16.94
4.9
# Points 6 8 7 32 6 8
# Labs 2 2 2 3 2 2

Mean 78.83 78.12 223.0 214.3 348.0 345.5
SD
CV
1 8.59
10.9
7.41
9.5
2 12.71
5.7
22.93
10.7
3 19.27
5.5
16.94
4.9
# Points 6 8 7 32 6 8
# Labs 2 2 2 3 2 2
T3, Total FIA ng/mL

Mean 0.788 0.781 2.23 2.14 3.48 3.46
SD
CV
1 0.086
10.9
0.074
9.5
2 0.127
5.7
0.229
10.7
3 0.193
5.5
0.169
4.9
# Points 6 8 7 32 6 8
# Labs 2 2 2 3 2 2

Mean 0.788 0.781 2.23 2.14 3.48 3.46
SD
CV
1 0.086
10.9
0.074
9.5
2 0.127
5.7
0.229
10.7
3 0.193
5.5
0.169
4.9
# Points 6 8 7 32 6 8
# Labs 2 2 2 3 2 2
T4, Free Chemiluminescence ng/dL

1drop
Mean 1.45 1.39 −− −− −− −−
SD
CV
1 0.060
4.1
0.115
8.2
2 −−
−−
−−
−−
3 −−
−−
−−
−−
# Points 24 201 −− −− −− −−
# Labs 1 1
Abbott Alinity i
Mean 0.857 0.855 1.96 1.96 2.79 2.78
SD
CV
1 0.049
5.7
0.053
6.1
2 0.121
6.2
0.123
6.3
3 0.265
9.5
0.259
9.3
# Points 2245 6352 2241 6307 1524 3968
# Labs 77 81 76 80 59 62

Mean 0.907 0.899 2.09 2.03 −− −−
SD
CV
1 0.030
3.3
0.028
3.1
20.102
4.9
0.112
5.5
3 −−
−−
−−
−−
# Points 18 32 18 32 −− −−
# Labs 1 1 1 1

Mean 0.869 0.865 2.02 2.02 2.85 2.86
SD
CV
1 0.045
5.2
0.045
5.2
2 0.105
5.2
0.121
6.0
3 0.227
7.9
0.240
8.4
# Points 934 3806 687 2562 648 2760
# Labs 25 39 16 30 17 29
Abbott ARCHITECT (c, i, ci models) • Abbott ARCH i FT4, REF 7K65−29/34/39

Mean 0.803 0.814 2.01 1.93 2.84 2.72
SD
CV
1 0.026
3.3
0.034
4.2
2
0.079
3.9
0.094
4.9
3 0.196
6.9
0.197
7.2
# Points 27 115 24 109 25 108
# Labs 1 1 1 1 1 1

Mean 0.891 0.872 2.03 2.03 2.84 2.87
SD
CV
1 0.057
6.4
0.055
6.3
2
0.115
5.7
0.117
5.8
3 0.266
9.4
0.223
7.8
# Points 281 529 246 345 138 341
# Labs 18 20 16 17 15 17
Abbott ARCHITECT (c, i, ci models) • Alternate Calibration

Mean −− −− −− −− −− 2.97
SD
CV
1 −−
−−
−−
−−
2 −−
−−
−−
−−
3 −−
−−
0.342
11.5
# Points −− −− −− −− −− 20
# Labs 1

Mean 0.887 0.876 2.05 2.05 −− 2.77
SD
CV
1 0.027
3.1
0.023
2.7
2
0.026
1.3
0.023
1.1
3 −−
−−
0.032
1.1
# Points 26 74 26 50 −− 24
# Labs 1 1 1 1 1

Mean 0.851 0.876 1.98 2.05 −− −−
SD
CV
1 0.022
2.6
0.034
3.8
2 0.074
3.8
0.126
6.1
3 −−
−−
−−
−−
# Points 24 77 26 78 −− −−
# Labs 1 1 1 1

Mean 8.93 10.20 32.24 24.82 64.66 61.60
SD
CV
1 7.04
78.8
6.81
66.8
2 20.70
64.2
21.14
85.2
3 41.65
64.4
40.45
65.7
# Points 16 42 15 69 18 60
# Labs 2 2 3 4 2 3

Mean 0.836 0.864 2.34 2.31 3.40 3.59
SD
CV
1 0.060
7.2
0.133
15.4
2 0.131
5.6
0.133
5.8
3 0.192
5.7
0.606
16.9
# Points 370 1614 332 1104 368 1608
# Labs 23 25 18 19 22 24

Mean 0.783 0.778 2.30 2.31 3.51 3.53
SD
CV
1 0.064
8.2
0.068
8.7
2 0.161
7.0
0.158
6.9
3 0.194
5.5
0.196
5.6
# Points 897 3541 1092 4040 1083 3858
# Labs 43 54 48 58 50 60

DiaSorin LIAISON/XL
Mean 0.375 0.529 1.05 1.53 −− −−
SD
CV
1 0.427
113.9
0.484
91.6
2 1.31
124.3
1.56
101.9
3 −−
−−
−−
−−
# Points 11 14 13 16 −− −−
# Labs 2 2 2 2

Mean 0.974 0.987 3.30 3.25 −− −−
SD
CV
1 0.045
4.7
0.052
5.3
2 0.142
4.3
0.164
5.0
3 −−
−−
−−
−−
# Points 4 14 4 14 −− −−
# Labs 1 1 1 1
Mindray CL Series
Mean 1.06 1.38 3.05 3.53 4.65 4.79
SD
CV
1 0.198
18.7
0.329
23.9
2 0.425
13.9
0.568
16.1
3 0.505
10.9
0.300
6.3
# Points 48 153 71 442 37 190
# Labs 3 4 4 6 4 4

Mean 1.04 1.02 2.84 2.81 −− −−
SD
CV
1 0.169
16.3
0.148
14.5
2 0.384
13.5
0.349
12.4
3 −−
−−
−−
−−
# Points 24 63 25 64 −− −−
# Labs 2 2 2 2

Mean 0.733 0.758 1.69 1.71 2.59 2.52
SD
CV
1 0.289
39.4
0.266
35.0
2 0.779
46.0
0.774
45.2
3 1.04
40.1
1.08
42.7
# Points 168 370 177 403 169 388
# Labs 8 8 9 9 10 11

Mean 0.665 0.690 1.53 1.64 2.17 2.15
SD
CV
1 0.347
52.1
0.323
46.7
2 0.884
57.9
0.820
50.0
3 1.23
56.6
1.22
56.8
# Points 807 2974 818 2721 735 2185
# Labs 36 43 36 44 35 38

Mean 0.852 0.841 2.08 2.04 3.00 3.02
SD
CV
1 0.055
6.4
0.059
7.0
2 0.121
5.8
0.110
5.4
3 0.213
7.1
0.212
7.0
# Points 865 3373 839 3171 699 2890
# Labs 27 27 23 23 23 24

Mean 0.931 0.938 2.44 2.45 4.40 4.38
SD
CV
1 0.030
3.2
0.035
3.7
2 0.084
3.4
0.081
3.3
3 0.166
3.8
0.183
4.2
# Points 286 1252 233 1053 169 585
# Labs 11 11 10 10 8 8

Mean 0.949 0.941 2.35 2.33 4.17 4.14
SD
CV
1 0.018
1.8
0.020
2.2
2 0.044
1.9
0.056
2.4
3 0.083
2.0
0.123
3.0
# Points 58 328 26 36 57 326
# Labs 2 2 1 1 2 2

Mean 1.12 1.13 2.81 2.80 4.13 4.09
SD
CV
1 0.075
6.6
0.080
7.0
2 0.135
4.8
0.139
5.0
3 0.223
5.4
0.236
5.8
# Points 118 401 125 412 117 379
# Labs 6 6 6 6 6 6

Snibe MAGLUMI
Mean 1.28 1.24 3.10 3.02 4.19 4.26
SD
CV
1 0.122
9.5
0.078
6.3
2 0.175
5.6
0.199
6.6
3 0.827
19.7
0.730
17.1
# Points 6 22 11 20 6 13
# Labs 1 1 1 1 1 1

Mean 0.588 0.809 1.84 2.30 2.87 3.70
SD
CV
1 0.580
98.6
1.92
237.7
2 1.39
75.4
2.40
104.3
3 2.14
74.7
3.24
87.6
# Points 46 111 64 189 60 198
# Labs 5 7 5 7 5 7
Snibe MAGLUMI Series • Snibe MAGLUMI FT4 REF 130X03004M

Mean 1.22 1.21 3.05 2.98 4.99 4.90
SD
CV
1 0.147
12.0
0.121
10.0
0.244
8.0
2 0.180
6.0
3 0.336
6.7
0.243
5.0
# Points 4 18 4 19 4 18
# Labs 1 1 1 1 1 1
Tosoh AIA Models

Mean 0.997 0.919 2.88 2.67 4.49 4.25
SD
CV
1 0.021
2.1
0.061
6.6
2 0.160
5.6
0.149
5.6
3 0.140
3.1
0.213
5.0
# Points 3 28 3 28 3 25
# Labs 1 1 1 1 1 1

Mean 1.38 1.41 5.73 5.80 6.99 6.93
SD
CV
1 0.097
7.0
0.138
9.8
2 0.282
4.9
0.480
8.3
3 0.006
0.1
0.618
8.9
# Points 1465 7063 1451 6829 457 2362
# Labs 59 64 59 65 23 26

Mean −− −− 5.61 5.74 −− −−
SD
CV
1 −−
−−
−−
−−
2 0.171
3.0
0.226
3.9
3 −−
−−
−−
−−
# Points −− −− 31 152 −− −−
# Labs 1 1
VITROS Microwell Series • Alternate Formulation/Standardization

Mean 1.36 1.39 5.67 5.80 −− −−
SD
CV
1 0.070
5.1
0.080
5.7
2
0.160
2.8
0.216
3.7
3 −−
−−
−−
−−
# Points 34 181 33 175 −− −−
# Labs 1 1 1 1
YHLO iFlash 3000

Mean −− −− 2.98 2.98 4.99 4.99
SD
CV
1 −−
−−
−−
−−
2 0.116
3.9
0.116
3.9
3 0.155
3.1
0.155
3.1
# Points −− −− 39 39 39 39
# Labs 1 1 1 1

Mean 0.941 0.977 2.74 3.00 3.49 3.66
SD
CV
1 0.519
55.1
0.512
52.3
2 2.08
76.2
2.19
72.9
3 4.11
117.9
3.93
107.4
# Points 8749 32493 8615 30254 6356 22301
# Labs 357 405 343 392 286 326

1drop
Mean 14.50 13.93 −− −− −− −−
SD
CV
1 0.600
4.1
1.15
8.2
2 −−
−−
−−
−−
3 −−
−−
−−
−−
# Points 24 201 −− −− −− −−
# Labs 1 1

Abbott Alinity i
Mean 8.57 8.55 19.61 19.61 27.90 27.78
SD
CV
1 0.488
5.7
0.525
6.1
2 1.21
6.2
1.23
6.3
3 2.65
9.5
2.59
9.3
# Points 2245 6352 2241 6307 1524 3968
# Labs 77 81 76 80 59 62

Mean 9.07 8.99 20.88 20.25 −− −−
SD
CV
1 0.298
3.3
0.278
3.1
1.02
4.9
2 1.12
5.5
3 −−
−−
−−
−−
# Points 18 32 18 32 −− −−
# Labs 1 1 1 1

Mean 8.69 8.65 20.18 20.23 28.53 28.56
SD
CV
1 0.454
5.2
0.454
5.2
2 1.05
5.2
1.21
6.0
3 2.27
7.9
2.40
8.4
# Points 934 3806 687 2562 648 2760
# Labs 25 39 16 30 17 29
Abbott ARCHITECT (c, i, ci models) • Abbott ARCH i FT4, REF 7K65−29/34/39

Mean 8.03 8.14 20.10 19.32 28.42 27.22
SD
CV
1 0.264
3.3
0.340
4.2
0.793
3.9
2
0.940
4.9
3 1.96
6.9
1.97
7.2
# Points 27 115 24 109 25 108
# Labs 1 1 1 1 1 1

Mean 8.91 8.72 20.32 20.34 28.36 28.66
SD
CV
1 0.571
6.4
0.547
6.3
1.15
5.7
2
1.17
5.8
3 2.66
9.4
2.23
7.8
# Points 281 529 246 345 138 341
# Labs 18 20 16 17 15 17
Abbott ARCHITECT (c, i, ci models) • Alternate Calibration

Mean −− −− −− −− −− 29.67
SD
CV
1 −−
−−
−−
−−
2 −−
−−
−−
−−
3 −−
−−
3.42
11.5
# Points −− −− −− −− −− 20
# Labs 1

Mean 8.87 8.76 20.50 20.51 −− 27.72
SD
CV
1 0.272
3.1
0.232
2.7
0.257
1.3
2
0.235
1.1
3 −−
−−
0.317
1.1
# Points 26 74 26 50 −− 24
# Labs 1 1 1 1 1

Mean 8.51 8.76 19.77 20.53 −− −−
SD
CV
1 0.222
2.6
0.336
3.8
2 0.743
3.8
1.26
6.1
3 −−
−−
−−
−−
# Points 24 77 26 78 −− −−
# Labs 1 1 1 1

Mean 89.33 102.0 322.4 248.2 646.6 616.0
SD
CV
1 70.40
78.8
68.08
66.8
2 207.0
64.2
211.4
85.2
3 416.5
64.4
404.5
65.7
# Points 16 42 15 69 18 60
# Labs 2 2 3 4 2 3

Mean 8.36 8.64 23.35 23.06 33.95 35.87
SD
CV
1 0.600
7.2
1.33
15.4
2 1.31
5.6
1.33
5.8
3 1.92
5.7
6.06
16.9
# Points 370 1614 332 1104 368 1608
# Labs 23 25 18 19 22 24

Mean 7.83 7.78 23.04 23.08 35.13 35.27
SD
CV
1 0.641
8.2
0.675
8.7
2 1.61
7.0
1.58
6.9
3 1.94
5.5
1.96
5.6
# Points 897 3541 1092 4040 1083 3858
# Labs 43 54 48 58 50 60
DiaSorin LIAISON/XL
Mean 3.75 5.29 10.50 15.33 −− −−
SD
CV
1 4.27
113.9
4.84
91.6
2 13.05
124.3
15.63
101.9
3 −−
−−
−−
−−
# Points 11 14 13 16 −− −−
# Labs 2 2 2 2

Mean 9.74 9.87 32.99 32.51 −− −−
SD
CV
1 0.454
4.7
0.519
5.3
2 1.42
4.3
1.64
5.0
3 −−
−−
−−
−−
# Points 4 14 4 14 −− −−
# Labs 1 1 1 1
Mindray CL Series
Mean 10.59 13.77 30.49 35.28 46.46 47.91
SD
CV
1 1.98
18.7
3.29
23.9
2 4.25
13.9
5.68
16.1
3 5.05
10.9
3.00
6.3
# Points 48 153 71 442 37 190
# Labs 3 4 4 6 4 4

Mean 10.38 10.20 28.42 28.07 −− −−
SD
CV
1 1.69
16.3
1.48
14.5
2 3.84
13.5
3.49
12.4
3 −−
−−
−−
−−
# Points 24 63 25 64 −− −−
# Labs 2 2 2 2

Mean 7.33 7.58 16.94 17.11 25.86 25.22
SD
CV
1 2.89
39.4
2.66
35.0
2 7.79
46.0
7.74
45.2
3 10.36
40.1
10.77
42.7
# Points 168 370 177 403 169 388
# Labs 8 8 9 9 10 11

Mean 6.65 6.90 15.27 16.41 21.69 21.48
SD
CV
1 3.47
52.1
3.23
46.7
2 8.84
57.9
8.20
50.0
3 12.26
56.6
12.20
56.8
# Points 807 2974 818 2721 735 2185
# Labs 36 43 36 44 35 38

Mean 8.52 8.41 20.82 20.39 30.01 30.16
SD
CV
1 0.547
6.4
0.586
7.0
2 1.21
5.8
1.10
5.4
3 2.13
7.1
2.12
7.0
# Points 865 3373 839 3171 699 2890
# Labs 27 27 23 23 23 24

Mean 9.31 9.38 24.37 24.50 43.96 43.85
SD
CV
1 0.297
3.2
0.351
3.7
2 0.836
3.4
0.808
3.3
3 1.66
3.8
1.83
4.2
# Points 286 1252 233 1053 169 585
# Labs 11 11 10 10 8 8

Mean 9.49 9.41 23.52 23.31 41.73 41.37
SD
CV
1 0.175
1.8
0.205
2.2
2 0.440
1.9
0.563
2.4
3 0.834
2.0
1.23
3.0
# Points 58 328 26 36 57 326
# Labs 2 2 1 1 2 2

Mean 11.24 11.34 28.09 28.00 41.26 40.92
SD
CV
1 0.747
6.6
0.796
7.0
2 1.35
4.8
1.39
5.0
3 2.23
5.4
2.36
5.8
# Points 118 401 125 412 117 379
# Labs 6 6 6 6 6 6
Snibe MAGLUMI
Mean 12.80 12.38 30.95 30.22 41.90 42.58
SD
CV
1 1.22
9.5
0.783
6.3
2 1.75
5.6
1.99
6.6
3 8.27
19.7
7.30
17.1
# Points 6 22 11 20 6 13
# Labs 1 1 1 1 1 1

Mean 5.88 8.09 18.42 22.99 28.70 37.03
SD
CV
1 5.80
98.6
19.24
237.7
2 13.89
75.4
23.98
104.3
3 21.43
74.7
32.43
87.6
# Points 46 111 64 189 60 198
# Labs 5 7 5 7 5 7
Snibe MAGLUMI Series • Snibe MAGLUMI FT4 REF 130X03004M

Mean 12.20 12.09 30.50 29.80 49.85 48.96
SD
CV
1 1.47
12.0
1.21
10.0
2.44
8.0
2 1.80
6.0
3 3.36
6.7
2.43
5.0
# Points 4 18 4 19 4 18
# Labs 1 1 1 1 1 1
Tosoh AIA Models

Mean 9.97 9.19 28.77 26.67 44.90 42.46
SD
CV
1 0.208
2.1
0.607
6.6
2 1.60
5.6
1.49
5.6
3 1.40
3.1
2.13
5.0
# Points 3 28 3 28 3 25
# Labs 1 1 1 1 1 1

Mean 13.82 14.10 57.32 57.98 69.91 69.30
SD
CV
1 0.974
7.0
1.38
9.8
2 2.82
4.9
4.80
8.3
3 0.062
0.1
6.18
8.9
# Points 1465 7063 1451 6829 457 2362
# Labs 59 64 59 65 23 26

Mean −− −− 56.15 57.39 −− −−
SD
CV
1 −−
−−
−−
−−
2 1.71
3.0
2.26
3.9
3 −−
−−
−−
−−
# Points −− −− 31 152 −− −−
# Labs 1 1

Mean 13.60 13.94 56.70 58.03 −− −−
SD
CV
1 0.700
5.1
0.800
5.7
2
1.60
2.8
2.16
3.7
3 −−
−−
−−
−−
# Points 34 181 33 175 −− −−
# Labs 1 1 1 1
YHLO iFlash 3000

Mean −− −− 29.75 29.75 49.86 49.86
SD
CV
1 −−
−−
−−
−−
2 1.16
3.9
1.16
3.9
3 1.55
3.1
1.55
3.1
# Points −− −− 39 39 39 39
# Labs 1 1 1 1

Mean 9.41 9.77 27.35 29.99 34.87 36.57
SD
CV
1 5.19
55.1
5.12
52.3
2 20.85
76.2
21.86
72.9
3 41.10
117.9
39.28
107.4
# Points 8749 32493 8615 30254 6356 22301
# Labs 357 405 343 392 286 326
T4, Free EIA ng/dL

Mean 1.07 1.07 3.04 3.04 4.40 4.40
SD
CV
1 0.050
4.7
0.050
4.7
2 0.102
3.3
0.102
3.3
3 0.257
5.8
0.257
5.8
# Points 9 9 9 9 9 9
# Labs 1 1 1 1 1 1
Roche cobas c 303/503 • Roche Elecsys FT4 IV, REF 09043284

Mean 1.11 1.13 2.90 2.90 4.39 4.41
SD
CV
1 0.039
3.5
0.049
4.3
2
0.077
2.6
0.070
2.4
3 0.110
2.5
0.193
4.4
# Points 28 67 28 67 28 67
# Labs 1 1 1 1 1 1

Mean −− 0.755 −− 2.78 −− 4.34
SD
CV
1 −−
−−
0.108
14.3
2 −−
−−
0.228
8.2
3 −−
−−
0.246
5.7
# Points −− 46 −− 38 −− 35
# Labs 1 1 1
Tosoh AIA Models

Mean 0.922 0.910 2.60 2.59 4.19 4.22
SD
CV
1 0.043
4.7
0.068
7.5
2 0.096
3.7
0.176
6.8
3 0.120
2.9
0.240
5.7
# Points 47 271 49 277 25 73
# Labs 2 4 3 5 2 4

Mean 1.000 0.932 2.75 2.67 4.31 4.32
SD
CV
1 0.098
9.8
0.126
13.5
2 0.193
7.0
0.216
8.1
3 0.171
4.0
0.240
5.6
# Points 84 393 86 391 62 184
# Labs 4 7 5 8 4 7
T4, Free EIA pg/mL

Mean 10.71 10.71 30.44 30.44 43.99 43.99
SD
CV
1 0.501
4.7
0.501
4.7
2 1.02
3.3
1.02
3.3
3 2.57
5.8
2.57
5.8
# Points 9 9 9 9 9 9
# Labs 1 1 1 1 1 1
Roche cobas c 303/503 • Roche Elecsys FT4 IV, REF 09043284

Mean 11.07 11.25 29.00 29.04 43.89 44.06
SD
CV
1 0.386
3.5
0.486
4.3
2
0.769
2.6
0.701
2.4
3 1.10
2.5
1.93
4.4
# Points 28 67 28 67 28 67
# Labs 1 1 1 1 1 1

Mean −− 7.55 −− 27.84 −− 43.36
SD
CV
1 −−
−−
1.08
14.3
2 −−
−−
2.28
8.2
3 −−
−−
2.46
5.7
# Points −− 46 −− 38 −− 35
# Labs 1 1 1
Tosoh AIA Models

Mean 9.22 9.10 26.03 25.86 41.93 42.18
SD
CV
1 0.434
4.7
0.684
7.5
2 0.955
3.7
1.76
6.8
3 1.20
2.9
2.40
5.7
# Points 47 271 49 277 25 73
# Labs 2 4 3 5 2 4

Mean 10.00 9.32 27.46 26.70 43.11 43.18
SD
CV
1 0.984
9.8
1.26
13.5
2 1.93
7.0
2.16
8.1
3 1.71
4.0
2.40
5.6
# Points 84 393 86 391 62 184
# Labs 4 7 5 8 4 7
T4, Free Electrochemiluminescence (ECL) ng/dL

Mindray CL Series
Mean 1.29 1.30 −− −− 5.07 5.14
SD
CV
1 0.026
2.0
0.042
3.3
2 −−
−−
−−
−−
3 0.105
2.1
0.186
3.6
# Points 23 140 −− −− 23 139
# Labs 1 1 1 1

Mean 1.09 1.07 2.84 2.81 4.38 4.33
SD
CV
1 0.050
4.6
0.051
4.7
2 0.139
4.9
0.142
5.1
3 0.249
5.7
0.258
6.0
# Points 727 3205 750 3241 626 2753
# Labs 34 40 34 42 30 35
Mean 1.10 1.10 2.90 2.91 4.41 4.41
SD
CV
1 0.033
3.0
0.047
4.3
2
0.116
4.0
0.106
3.6
3 0.181
4.1
0.185
4.2
# Points 193 546 232 862 280 902
# Labs 9 10 10 10 12 13
Roche cobas 6000/8000/c 311 • Roche Elecsys FT4 IV, REF 09043276
Mean 1.10 1.08 2.88 2.85 4.43 4.38
SD
CV
1 0.048
4.4
0.046
4.3
2
0.138
4.8
0.138
4.8
3 0.274
6.2
0.270
6.2
# Points 119 378 120 392 126 341
# Labs 7 9 7 9 7 8
Mean 1.13 1.12 2.95 2.93 4.45 4.40
SD
CV
1 0.024
2.1
0.026
2.3
2
0.061
2.1
0.068
2.3
3 0.109
2.4
0.130
3.0
# Points 107 158 107 156 106 155
# Labs 2 2 2 2 2 2
Roche cobas 6000/8000/c 311 • Roche FT4 II, REF 06437281

Mean 1.10 1.07 2.85 2.76 4.43 4.23
SD
CV
1 0.036
3.3
0.039
3.7
2
0.108
3.8
0.131
4.8
3 0.217
4.9
0.224
5.3
# Points 35 175 35 176 27 166
# Labs 3 3 3 3 2 2

Mean 1.14 1.12 2.97 3.00 4.56 4.53
SD
CV
1 0.054
4.7
0.058
5.2
2 0.106
3.6
0.110
3.7
3 0.228
5.0
0.232
5.1
# Points 457 1570 161 585 351 1340
# Labs 19 22 9 13 16 20

Mean 1.16 1.14 3.01 2.99 4.69 4.60
SD
CV
1 0.037
3.2
0.043
3.8
2
0.092
3.0
0.097
3.3
3 0.247
5.3
0.244
5.3
# Points 695 2300 449 1389 346 1183
# Labs 18 18 13 13 11 11
Roche cobas e 402/801 • Roche Elecsys FT4 IV, REF 09043276

Mean 1.14 1.14 3.01 2.98 4.39 4.38
SD
CV
1 0.037
3.3
0.033
2.9
2
0.040
1.3
0.061
2.1
3 0.067
1.5
0.090
2.1
# Points 28 64 12 29 16 35
# Labs 1 1 1 1 1 1

Mean 1.14 1.14 3.00 2.97 4.45 4.43
SD
CV
1 0.043
3.8
0.038
3.4
2
0.093
3.1
0.094
3.2
3 0.148
3.3
0.139
3.1
# Points 923 2587 795 2333 351 952
# Labs 23 25 19 21 16 18
T4, Free Electrochemiluminescence (ECL) ng/dL

Roche cobas u 601
Mean 1.09 1.10 2.83 2.87 4.37 4.42
SD
CV
1 0.028
2.6
0.025
2.3
2 0.095
3.3
0.084
2.9
3 0.159
3.6
0.151
3.4
# Points 16 37 17 40 15 39
# Labs 1 1 1 1 1 1

Mean 1.09 1.08 2.90 2.85 4.44 4.38
SD
CV
1 0.063
5.8
0.061
5.7
2 0.238
8.2
0.247
8.7
3 0.269
6.1
0.328
7.5
# Points 618 2223 662 2375 579 1977
# Labs 37 42 41 46 38 43
Roche Elecsys / cobas e 411 Series • 4th Generation

Mean 1.13 1.12 3.02 2.99 4.71 4.66
SD
CV
1 0.098
8.6
0.081
7.2
2 0.219
7.3
0.216
7.2
3 0.389
8.3
0.425
9.1
# Points 67 176 65 158 39 76
# Labs 3 3 3 3 2 2
Roche Elecsys / cobas e 411 Series • Roche ECL FT4, REF 11731297
Mean 1.08 1.11 2.91 2.97 4.42 4.53
SD
CV
1 0.039
3.7
0.045
4.1
2
0.101
3.5
0.112
3.8
3 0.162
3.7
0.198
4.4
# Points 38 120 37 122 33 113
# Labs 2 2 2 2 2 2
Mean 1.06 1.05 2.88 4.96 4.33 8.98
SD
CV
1 0.050
4.8
0.060
5.7
2
0.113
3.9
9.39
189.4
3 0.262
6.0
19.55
217.6
# Points 75 190 105 293 106 268
# Labs 6 8 8 11 8 10
Roche Elecsys / cobas e 411 Series • Roche Elecsys FT4 IV, REF 09043276
Mean 1.04 1.04 2.81 2.79 4.29 4.26
SD
CV
1 0.030
2.9
0.039
3.8
2
0.055
2.0
0.074
2.7
3 0.088
2.0
0.127
3.0
# Points 91 261 96 268 80 240
# Labs 6 6 6 6 5 5
Roche Elecsys / cobas e 411 Series • Roche FT4 II, REF 06437281
Mean 1.05 1.01 2.86 2.83 4.25 4.03
SD
CV
1 0.060
5.7
0.135
13.3
2
0.225
7.9
0.185
6.5
3 0.536
12.6
0.722
17.9
# Points 80 188 70 119 48 153
# Labs 4 6 4 4 5 6

Mean 1.12 1.11 2.92 2.94 4.46 4.53
SD
CV
1 0.059
5.3
0.064
5.8
2 0.160
5.5
1.48
50.3
3 0.265
5.9
3.16
69.8
# Points 4292 14318 3713 12538 3152 10832
# Labs 176 199 163 187 159 180

Mindray CL Series
Mean 12.90 12.98 −− −− 50.66 51.43
SD
CV
1 0.256
2.0
0.425
3.3
2 −−
−−
−−
−−
3 1.05
2.1
1.86
3.6
# Points 23 140 −− −− 23 139
# Labs 1 1 1 1

Mean 10.89 10.73 28.44 28.07 43.77 43.27
SD
CV
1 0.498
4.6
0.506
4.7
2 1.39
4.9
1.42
5.1
3 2.49
5.7
2.58
6.0
# Points 727 3205 750 3241 626 2753
# Labs 34 40 34 42 30 35

Mean 10.97 11.00 28.95 29.05 44.12 44.08
SD
CV
1 0.334
3.0
0.472
4.3
2
1.16
4.0
1.06
3.6
3 1.81
4.1
1.85
4.2
# Points 193 546 232 862 280 902
# Labs 9 10 10 10 12 13
Mean 10.98 10.76 28.79 28.50 44.33 43.76
SD
CV
1 0.481
4.4
0.458
4.3
2
1.38
4.8
1.38
4.8
3 2.74
6.2
2.70
6.2
# Points 119 378 120 392 126 341
# Labs 7 9 7 9 7 8
Mean 11.30 11.25 29.50 29.31 44.49 43.99
SD
CV
1 0.241
2.1
0.261
2.3
2
0.610
2.1
0.679
2.3
3 1.09
2.4
1.30
3.0
# Points 107 158 107 156 106 155
# Labs 2 2 2 2 2 2
Roche cobas 6000/8000/c 311 • Roche FT4 II, REF 06437281

Mean 10.98 10.73 28.47 27.58 44.27 42.28
SD
CV
1 0.360
3.3
0.393
3.7
2
1.08
3.8
1.31
4.8
3 2.17
4.9
2.24
5.3
# Points 35 175 35 176 27 166
# Labs 3 3 3 3 2 2

Mean 11.43 11.23 29.74 29.96 45.61 45.33
SD
CV
1 0.538
4.7
0.585
5.2
2 1.06
3.6
1.10
3.7
3 2.28
5.0
2.32
5.1
# Points 457 1570 161 585 351 1340
# Labs 19 22 9 13 16 20

Mean 11.55 11.43 30.07 29.88 46.89 45.95
SD
CV
1 0.371
3.2
0.434
3.8
2
0.916
3.0
0.975
3.3
3 2.47
5.3
2.44
5.3
# Points 695 2300 449 1389 346 1183
# Labs 18 18 13 13 11 11

Mean 11.35 11.38 30.14 29.75 43.88 43.82
SD
CV
1 0.370
3.3
0.328
2.9
2
0.399
1.3
0.612
2.1
3 0.669
1.5
0.899
2.1
# Points 28 64 12 29 16 35
# Labs 1 1 1 1 1 1

Mean 11.41 11.39 29.95 29.66 44.48 44.26
SD
CV
1 0.430
3.8
0.383
3.4
2
0.931
3.1
0.936
3.2
3 1.48
3.3
1.39
3.1
# Points 923 2587 795 2333 351 952
# Labs 23 25 19 21 16 18
Roche cobas u 601

Mean 10.88 11.01 28.30 28.69 43.73 44.25
SD
CV
1 0.280
2.6
0.252
2.3
2 0.948
3.3
0.842
2.9
3 1.59
3.6
1.51
3.4
# Points 16 37 17 40 15 39
# Labs 1 1 1 1 1 1

Mean 10.95 10.80 29.04 28.48 44.45 43.85
SD
CV
1 0.630
5.8
0.614
5.7
2 2.38
8.2
2.47
8.7
3 2.69
6.1
3.28
7.5
# Points 618 2223 662 2375 579 1977
# Labs 37 42 41 46 38 43

Roche Elecsys / cobas e 411 Series • 4th Generation
Mean 11.29 11.17 30.21 29.89 47.06 46.63
SD
CV
1 0.976
8.6
0.809
7.2
2 2.19
7.3
2.16
7.2
3 3.89
8.3
4.25
9.1
# Points 67 176 65 158 39 76
# Labs 3 3 3 3 2 2
Roche Elecsys / cobas e 411 Series • Roche ECL FT4, REF 11731297
Mean 10.80 11.07 29.13 29.67 44.16 45.33
SD
CV
1 0.395
3.7
0.450
4.1
2
1.01
3.5
1.12
3.8
3 1.62
3.7
1.98
4.4
# Points 38 120 37 122 33 113
# Labs 2 2 2 2 2 2
Mean 10.56 10.51 28.78 49.60 43.30 89.83
SD
CV
1 0.504
4.8
0.602
5.7
2
1.13
3.9
93.93
189.4
3 2.62
6.0
195.5
217.6
# Points 75 190 105 293 106 268
# Labs 6 8 8 11 8 10
Roche Elecsys / cobas e 411 Series • Roche Elecsys FT4 IV, REF 09043276
Mean 10.44 10.43 28.15 27.95 42.91 42.55
SD
CV
1 0.305
2.9
0.394
3.8
2
0.551
2.0
0.743
2.7
3 0.876
2.0
1.27
3.0
# Points 91 261 96 268 80 240
# Labs 6 6 6 6 5 5
Roche Elecsys / cobas e 411 Series • Roche FT4 II, REF 06437281
Mean 10.50 10.13 28.59 28.33 42.55 40.34
SD
CV
1 0.601
5.7
1.35
13.3
2
2.25
7.9
1.85
6.5
3 5.36
12.6
7.22
17.9
# Points 80 188 70 119 48 153
# Labs 4 6 4 4 5 6

Mean 11.19 11.06 29.25 29.37 44.64 45.34
SD
CV
1 0.589
5.3
0.642
5.8
2 1.60
5.5
14.77
50.3
3 2.65
5.9
31.63
69.8
# Points 4292 14318 3713 12538 3152 10832
# Labs 176 199 163 187 159 180
T4, Free FIA ng/dL

Mean 1.11 1.10 3.07 3.16 4.40 4.49
SD
CV
1 0.090
8.1
0.068
6.2
2 0.050
1.6
0.136
4.3
3 0.065
1.5
0.189
4.2
# Points 6 17 4 15 5 15
# Labs 2 2 2 2 2 2
bioMérieux VIDAS Group • bioMérieux VIDAS FT4N (REF 30459)

Mean 0.990 1.07 2.93 3.03 4.42 4.42
SD
CV
1 0.020
2.0
0.120
11.2
0.090
3.1
2 0.164
5.4
3 0.324
7.3
0.323
7.3
# Points 4 6 4 27 16 24
# Labs 1 1 1 2 2 2

Mean 1.06 1.09 3.00 3.08 4.42 4.45
SD
CV
1 0.093
8.7
0.082
7.6
2 0.103
3.4
0.165
5.4
3 0.283
6.4
0.278
6.3
# Points 10 23 8 42 21 39
# Labs 3 3 3 4 4 4
T4, Free FIA pg/mL

Mean 11.12 10.96 30.75 31.58 44.00 44.86
SD
CV
1 0.900
8.1
0.679
6.2
2 0.501
1.6
1.36
4.3
3 0.655
1.5
1.89
4.2
# Points 6 17 4 15 5 15
# Labs 2 2 2 2 2 2
bioMérieux VIDAS Group • bioMérieux VIDAS FT4N (REF 30459)

Mean 9.90 10.67 29.30 30.32 44.20 44.20
SD
CV
1 0.200
2.0
1.20
11.2
0.900
3.1
2 1.64
5.4
3 3.24
7.3
3.23
7.3
# Points 4 6 4 27 16 24
# Labs 1 1 1 2 2 2

Mean 10.63 10.88 30.02 30.77 44.15 44.45
SD
CV
1 0.927
8.7
0.824
7.6
2 1.03
3.4
1.65
5.4
3 2.83
6.4
2.78
6.3
# Points 10 23 8 42 21 39
# Labs 3 3 3 4 4 4
T4, Total Chemiluminescence µg/dL

Mean 5.51 5.53 11.00 11.00 14.49 14.49
SD
CV
1 0.299
5.4
0.296
5.3
2 0.582
5.3
0.599
5.4
3 1.01
6.9
0.960
6.6
# Points 1843 6026 1752 5608 1696 5575
# Labs 67 76 63 74 64 74
Abbott ARCHITECT/Alinity (c, i, ci models) • Abbott ARCH i TT4, REF 7K66−25/30/35

Mean 5.21 35.86 10.54 52.39 13.77 60.59
SD
CV
1 0.328
6.3
34.43
96.0
2
0.654
6.2
62.08
118.5
3 1.23
9.0
72.06
118.9
# Points 69 436 99 628 99 560
# Labs 4 8 5 8 5 8
Abbott ARCHITECT/Alinity (c, i, ci models) • Abbott ARCH i TT4, REF 7K66−27/32/37

Mean 5.58 5.34 10.72 10.66 14.60 14.24
SD
CV
1 0.344
6.2
0.365
6.8
2
0.604
5.6
0.535
5.0
3 0.824
5.6
0.725
5.1
# Points 69 262 64 216 47 195
# Labs 5 8 4 6 4 6
Abbott ARCHITECT/Alinity (c, i, ci models) • Abbott Architect Total T4, Lots >2290xJN00
Mean 5.46 5.48 10.95 11.03 −− −−
SD
CV
1 0.240
4.4
0.233
4.2
2
0.460
4.2
0.484
4.4
3 −−
−−
−−
−−
# Points 52 177 51 179 −− −−
# Labs 1 1 1 1

Mean 5.33 5.41 11.11 11.21 14.96 15.15
SD
CV
1 0.173
3.2
0.230
4.3
2
0.444
4.0
0.463
4.1
3 0.468
3.1
0.475
3.1
# Points 32 122 32 121 32 121
# Labs 1 1 1 1 1 1

Mean −− −− 14.40 12.87 20.90 18.30
SD
CV
1 −−
−−
−−
−−
2 0.888
6.2
1.60
12.4
3 1.45
6.9
2.92
16.0
# Points −− −− 21 62 20 40
# Labs 1 2 1 2

Mean 6.10 6.03 12.25 12.24 15.66 15.63
SD
CV
1 0.495
8.1
0.520
8.6
2 0.969
7.9
0.960
7.8
3 1.11
7.1
1.28
8.2
# Points 264 922 261 917 228 823
# Labs 14 17 14 16 13 17

Mean 5.79 5.85 12.08 12.21 15.27 15.37
SD
CV
1 0.575
9.9
0.621
10.6
2 0.979
8.1
0.957
7.8
3 1.19
7.8
1.21
7.9
# Points 759 2908 950 3376 942 3379
# Labs 36 48 42 52 43 52
Dirui CS Series
Mean −− 0.581 −− 1.08 −− −−
SD
CV
1 −−
−−
0.024
4.2
2 −−
−−
0.042
3.8
3 −−
−−
−−
−−
# Points −− 75 −− 73 −− −−
# Labs 1 1
Mindray CL Series
Mean 6.01 48.16 8.38 46.65 15.65 15.23
SD
CV
1 0.339
5.6
35.82
74.4
2 5.23
62.4
62.91
134.9
3 0.941
6.0
0.876
5.8
# Points 26 123 39 273 30 55
# Labs 2 3 3 5 3 3

Mean 5.84 5.98 12.59 12.80 16.58 17.11
SD
CV
1 0.500
8.6
0.602
10.1
2 0.889
7.1
1.18
9.2
3 1.26
7.6
1.59
9.3
# Points 70 169 80 208 92 205
# Labs 3 3 3 4 4 4

Mean 5.64 5.57 12.47 12.32 16.39 16.29
SD
CV
1 0.387
6.9
0.433
7.8
2 0.679
5.4
0.768
6.2
3 0.887
5.4
0.892
5.5
# Points 1096 3269 1187 3271 956 2517
# Labs 44 51 43 48 41 45

Mean 5.55 5.65 11.89 12.20 15.40 15.88
SD
CV
1 0.384
6.9
0.586
10.4
2 0.804
6.8
1.04
8.5
3 1.14
7.4
1.35
8.5
# Points 463 1705 441 1477 423 1499
# Labs 18 18 14 14 15 15

Mean 3.86 3.39 8.22 7.23 10.85 9.16
SD
CV
1 2.23
57.8
2.43
71.6
2 5.01
60.9
5.27
73.0
3 6.37
58.7
6.74
73.6
# Points 42 82 42 82 41 81
# Labs 5 5 5 5 5 5

Mean 2.80 2.45 8.81 10.31 9.39 11.14
SD
CV
1 2.73
97.5
2.54
103.7
2 5.48
62.2
4.85
47.0
3 6.96
74.2
6.85
61.5
# Points 50 95 90 282 72 190
# Labs 2 4 4 6 3 4

Mean 5.45 5.51 11.95 12.02 15.85 15.93
SD
CV
1 0.278
5.1
0.293
5.3
2 0.618
5.2
0.641
5.3
3 0.751
4.7
0.792
5.0
# Points 1193 5763 1084 5439 1099 5552
# Labs 52 59 48 56 50 56
YHLO iFlash 3000

Mean −− −− 11.73 11.73 −− −−
SD
CV
1 −−
−−
−−
−−
2 0.351
3.0
0.351
3.0
3 −−
−−
−−
−−
# Points −− −− 24 24 −− −−
# Labs 1 1

Mean 5.56 6.41 11.69 13.35 15.27 16.61
SD
CV
1 0.588
10.6
7.65
119.4
2 1.38
11.8
14.80
110.9
3 1.75
11.5
14.02
84.4
# Points 5996 22012 6185 22115 5745 20671
# Labs 253 302 251 299 251 291
T4, Total EIA µg/dL

Mean 5.97 6.12 10.47 10.87 14.27 14.96
SD
CV
1 0.255
4.3
0.299
4.9
2 0.351
3.4
0.608
5.6
3 0.699
4.9
1.31
8.8
# Points 48 229 48 229 48 229
# Labs 2 2 2 2 2 2

Mean 6.08 6.07 11.38 11.38 −− −−
SD
CV
1 0.219
3.6
0.215
3.6
0.2852
2.5
0.290
2.6
3 −−
−−
−−
−−
# Points 149 273 158 280 −− −−
# Labs 3 3 3 3

Mean 6.40 6.40 12.69 12.69 15.64 15.64
SD
CV
1 0.381
6.0
0.381
6.0
2 0.556
4.4
0.556
4.4
3 0.464
3.0
0.464
3.0
# Points 5 5 5 5 5 5
# Labs 1 1 1 1 1 1

Mean 5.65 5.60 10.53 10.47 13.62 13.51
SD
CV
1 0.114
2.0
0.150
2.7
0.194
1.8
2 0.248
2.4
3 0.316
2.3
0.364
2.7
# Points 27 69 27 69 27 69
# Labs 1 1 1 1 1 1

Mean 6.38 6.37 11.37 11.40 16.49 16.64
SD
CV
1 0.464
7.3
0.441
6.9
2 0.457
4.0
0.408
3.6
3 0.661
4.0
0.582
3.5
# Points 68 162 32 63 21 51
# Labs 3 3 2 2 1 1
Tosoh AIA Models

Mean 4.88 4.91 9.76 9.55 12.46 12.29
SD
CV
1 0.157
3.2
0.190
3.9
2 1.04
10.7
0.723
7.6
3 0.894
7.2
0.713
5.8
# Points 23 73 27 76 26 79
# Labs 1 2 2 3 2 3

Mean 6.01 6.00 11.03 10.95 14.18 14.45
SD
CV
1 0.468
7.8
0.490
8.2
2 0.731
6.6
0.753
6.9
3 1.45
10.2
1.67
11.5
# Points 320 811 297 722 127 433
# Labs 11 12 11 12 7 8
T4, Total Electrochemiluminescence (ECL) µg/dL

Mindray CL Series
Mean 6.17 6.17 −− −− 15.45 15.54
SD
CV
1 0.120
1.9
0.283
4.6
2 −−
−−
−−
−−
3 0.270
1.7
0.656
4.2
# Points 23 140 −− −− 23 139
# Labs 1 1 1 1
T4, Total Electrochemiluminescence (ECL) µg/dL

Mean 5.51 5.58 10.42 10.47 13.57 13.56
SD
CV
1 0.327
5.9
0.306
5.5
2 0.658
6.3
0.577
5.5
3 0.901
6.6
0.748
5.5
# Points 626 2974 848 4029 820 3618
# Labs 36 45 40 49 38 42

Mean 5.61 5.59 10.69 10.63 13.84 13.67
SD
CV
1 0.321
5.7
0.317
5.7
2 0.707
6.6
0.662
6.2
3 0.823
5.9
0.773
5.7
# Points 775 2300 593 1620 653 2207
# Labs 29 35 23 28 26 32

Mean 5.62 5.58 10.73 10.53 13.62 13.59
SD
CV
1 0.273
4.9
0.278
5.0
2
0.269
2.5
0.425
4.0
3 0.650
4.8
0.563
4.1
# Points 157 502 64 155 131 395
# Labs 5 5 3 3 5 5

Mean 5.67 5.55 10.60 10.28 13.70 13.31
SD
CV
1 0.209
3.7
0.282
5.1
2
0.457
4.3
0.559
5.4
3 0.640
4.7
0.621
4.7
# Points 35 149 38 157 26 70
# Labs 3 3 3 3 2 2
Mean 5.75 5.40 10.98 10.54 14.33 13.56
SD
CV
1 0.251
4.4
0.329
6.1
2
0.215
2.0
0.435
4.1
3 0.541
3.8
0.758
5.6
# Points 21 107 21 107 21 107
# Labs 1 1 1 1 1 1

Mean 5.79 5.68 10.99 10.82 14.09 13.97
SD
CV
1 0.456
7.9
0.447
7.9
2 0.759
6.9
0.775
7.2
3 0.873
6.2
0.899
6.4
# Points 812 2524 835 2753 780 2418
# Labs 44 46 48 52 46 50

Mean 5.65 5.62 10.70 10.61 13.84 13.73
SD
CV
1 0.387
6.8
0.364
6.5
2 0.735
6.9
0.676
6.4
3 0.892
6.4
0.838
6.1
# Points 2449 8696 2399 8821 2454 8954
# Labs 119 136 118 136 119 133
T4, Total FIA µg/dL

Mean 6.28 6.33 12.44 12.35 16.02 16.02
SD
CV
1 0.274
4.4
0.270
4.3
2 0.348
2.8
0.812
6.6
3 0.492
3.1
0.731
4.6
# Points 7 9 7 31 7 9
# Labs 2 2 2 3 2 2

Mean 6.28 6.33 12.44 12.35 16.02 16.02
SD
CV
1 0.274
4.4
0.270
4.3
2 0.348
2.8
0.812
6.6
3 0.492
3.1
0.731
4.6
# Points 7 9 7 31 7 9
# Labs 2 2 2 3 2 2
TBG (Thyroxine−Binding Globulin) Chemiluminescence µg/mL

Mean 25.14 27.19 15.30 15.35 −− −−
SD
CV
1 5.95
23.7
4.42
16.2
2 1.46
9.6
1.76
11.4
3 −−
−−
−−
−−
# Points 29 226 28 223 −− −−
# Labs 2 2 2 2

Mean 25.14 27.19 15.30 15.35 −− −−
SD
CV
1 5.95
23.7
4.42
16.2
2 1.46
9.6
1.76
11.4
3 −−
−−
−−
−−
# Points 29 226 28 223 −− −−
# Labs 2 2 2 2
Testosterone Chemiluminescence ng/dL

Mean 184.7 185.3 407.6 410.9 873.4 878.1
SD
CV
1 8.86
4.8
8.97
4.8
2 18.81
4.6
19.26
4.7
3 44.66
5.1
44.08
5.0
# Points 1809 5462 1514 4581 1456 4568
# Labs 55 62 45 52 51 56

Mean −− 177.0 −− 407.6 −− 853.9
SD
CV
1 −−
−−
20.40
11.5
2−−
−−
34.58
8.5
3 −−
−−
71.40
8.4
# Points −− 40 −− 41 −− 40
# Labs 1 1 1

Mean 41.82 42.18 138.7 138.0 338.3 342.9
SD
CV
1 5.99
14.3
3.55
8.4
2 24.09
17.4
14.19
10.3
3 47.66
14.1
33.58
9.8
# Points 8 26 9 26 12 31
# Labs 1 1 1 1 1 1

Mean 114.8 120.9 361.4 363.9 734.0 786.1
SD
CV
1 16.50
14.4
12.61
10.4
2 24.43
6.8
24.34
6.7
3 57.45
7.8
60.56
7.7
# Points 14 48 9 10 13 46
# Labs 4 5 3 3 4 5

Mean 111.5 111.2 344.1 346.9 695.8 681.0
SD
CV
1 8.91
8.0
8.78
7.9
2 26.63
7.7
26.14
7.5
3 52.21
7.5
58.18
8.5
# Points 580 2802 612 2503 710 2986
# Labs 35 45 37 45 39 47
DiaSorin LIAISON/XL
Mean 56.45 56.45 −− −− 378.5 378.5
SD
CV
1 8.07
14.3
8.07
14.3
2 −−
−−
−−
−−
3 52.44
13.9
52.44
13.9
# Points 4 4 −− −− 4 4
# Labs 1 1 1 1
Dirui CS Series
Mean −− 19476 −− 52479 −− −−
SD
CV
1 −−
−−
240.6
1.2
2 −−
−−
863.9
1.6
3 −−
−−
−−
−−
# Points −− 35 −− 33 −− −−
# Labs 1 1
Mindray CL Series
Mean 152.3 150.4 518.2 454.1 1270 1270
SD
CV
1 9.04
5.9
8.80
5.8
2 82.30
15.9
59.24
13.0
3 15.14
1.2
15.14
1.2
# Points 29 39 41 187 6 6
# Labs 2 2 3 4 1 1

Mean −− 127.2 409.4 386.2 −− 681.2
SD
CV
1 −−
−−
35.80
28.1
2 25.18
6.2
61.25
15.9
3 −−
−−
0.000
0.0
# Points −− 3 5 6 −− 1
# Labs 1 1 1 1
Siemens ADVIA Centaur CP • Siemens Centaur Testosterone (TSTO)

Mean 161.0 161.0 −− −− 772.7 754.6
SD
CV
1 0.000
0.0
0.000
0.0
2
−−
−−
−−
−−
3 19.36
2.5
34.24
4.5
# Points 1 1 −− −− 2 3
# Labs 1 1 1 2
Siemens ADVIA Centaur CP • Siemens Centaur Testosterone II (TSTII)

Mean −− −− 319.1 350.6 610.3 665.3
SD
CV
1 −−
−−
−−
−−
2
0.000
0.0
30.42
8.7
3 23.50
3.9
78.67
11.8
# Points −− −− 1 3 2 6
# Labs 1 1 1 1

Mean 172.5 170.1 398.9 391.0 772.8 765.5
SD
CV
1 14.30
8.3
19.21
11.3
2 40.92
10.3
42.65
10.9
3 96.33
12.5
77.58
10.1
# Points 152 591 142 481 117 367
# Labs 7 11 7 11 5 8
Siemens ADVIA Centaur Systems • Siemens Centaur Testosterone (TSTO)

Mean 177.3 179.6 397.0 410.7 757.9 773.5
SD
CV
1 9.89
5.6
17.23
9.6
2
31.80
8.0
45.82
11.2
3 57.96
7.6
82.25
10.6
# Points 61 168 80 165 60 144
# Labs 2 2 2 2 2 2
Siemens ADVIA Centaur Systems • Siemens Centaur Testosterone II (TSTII)

Mean 182.4 184.1 411.5 419.4 763.7 775.6
SD
CV
1 13.06
7.2
14.37
7.8
2
30.75
7.5
32.83
7.8
3 65.50
8.6
73.23
9.4
# Points 294 1057 280 1050 287 1064
# Labs 13 14 13 14 13 14

Mean 167.8 168.3 418.0 415.9 766.4 751.4
SD
CV
1 8.47
5.0
8.18
4.9
2 22.84
5.5
23.50
5.7
3 40.65
5.3
47.51
6.3
# Points 429 1768 441 1780 415 1659
# Labs 14 15 14 15 14 14

Mean 119.5 117.1 477.4 471.6 1034 1018
SD
CV
1 16.49
13.8
15.29
13.1
2 48.47
10.2
49.19
10.4
3 99.85
9.7
108.1
10.6
# Points 93 215 99 220 71 171
# Labs 6 7 7 7 6 6

Mean 124.4 126.9 340.9 342.6 615.5 620.3
SD
CV
1 12.17
9.8
12.62
9.9
2 17.30
5.1
23.34
6.8
3 27.77
4.5
40.08
6.5
# Points 122 293 120 287 121 287
# Labs 5 8 5 8 5 7

Mean 109.5 109.8 494.8 495.2 1178 1183
SD
CV
1 7.53
6.9
6.82
6.2
2 27.75
5.6
26.78
5.4
3 59.51
5.1
55.54
4.7
# Points 687 3535 588 2959 591 3038
# Labs 39 45 35 40 35 40

Mean 156.4 150.6 411.8 417.3 855.6 870.3
SD
CV
1 35.06
22.4
36.42
24.2
2 55.00
13.4
56.61
13.6
3 170.9
20.0
189.9
21.8
# Points 4283 16012 3941 14258 3867 14381
# Labs 185 220 174 204 179 206
Testosterone Chemiluminescence ng/mL

Mean 1.85 1.85 4.08 4.11 8.73 8.78
SD
CV
1 0.089
4.8
0.090
4.8
2 0.188
4.6
0.193
4.7
3 0.447
5.1
0.441
5.0
# Points 1809 5462 1514 4581 1456 4568
# Labs 55 62 45 52 51 56

Mean −− 1.77 −− 4.08 −− 8.54
SD
CV
1 −−
−−
0.204
11.5
2−−
−−
0.346
8.5
3 −−
−−
0.714
8.4
# Points −− 40 −− 41 −− 40
# Labs 1 1 1

Mean 0.418 0.422 1.39 1.38 3.38 3.43
SD
CV
1 0.060
14.3
0.035
8.4
2 0.241
17.4
0.142
10.3
3 0.477
14.1
0.336
9.8
# Points 8 26 9 26 12 31
# Labs 1 1 1 1 1 1

Mean 1.15 1.21 3.61 3.64 7.34 7.86
SD
CV
1 0.165
14.4
0.126
10.4
2 0.244
6.8
0.243
6.7
3 0.575
7.8
0.606
7.7
# Points 14 48 9 10 13 46
# Labs 4 5 3 3 4 5

Mean 1.11 1.11 3.44 3.47 6.96 6.81
SD
CV
1 0.089
8.0
0.088
7.9
2 0.266
7.7
0.261
7.5
3 0.522
7.5
0.582
8.5
# Points 580 2802 612 2503 710 2986
# Labs 35 45 37 45 39 47
DiaSorin LIAISON/XL
Mean 0.565 0.565 −− −− 3.79 3.79
SD
CV
1 0.081
14.3
0.081
14.3
2 −−
−−
−−
−−
3 0.524
13.9
0.524
13.9
# Points 4 4 −− −− 4 4
# Labs 1 1 1 1
Dirui CS Series
Mean −− 194.8 −− 524.8 −− −−
SD
CV
1 −−
−−
2.41
1.2
2 −−
−−
8.64
1.6
3 −−
−−
−−
−−
# Points −− 35 −− 33 −− −−
# Labs 1 1
Mindray CL Series
Mean 1.52 1.50 5.18 4.54 12.70 12.70
SD
CV
1 0.090
5.9
0.088
5.8
2 0.823
15.9
0.592
13.0
3 0.151
1.2
0.151
1.2
# Points 29 39 41 187 6 6
# Labs 2 2 3 4 1 1

Mean −− 1.27 4.09 3.86 −− 6.81
SD
CV
1 −−
−−
0.358
28.1
2 0.252
6.2
0.613
15.9
3 −−
−−
0.000
0.0
# Points −− 3 5 6 −− 1
# Labs 1 1 1 1
Testosterone Chemiluminescence ng/mL

Siemens ADVIA Centaur CP • Siemens Centaur Testosterone (TSTO)
Mean 1.61 1.61 −− −− 7.73 7.55
SD
CV
1 0.000
0.0
0.000
0.0
2
−−
−−
−−
−−
3 0.194
2.5
0.342
4.5
# Points 1 1 −− −− 2 3
# Labs 1 1 1 2
Siemens ADVIA Centaur CP • Siemens Centaur Testosterone II (TSTII)

Mean −− −− 3.19 3.51 6.10 6.65
SD
CV
1 −−
−−
−−
−−
2
0.000
0.0
0.304
8.7
3 0.235
3.9
0.787
11.8
# Points −− −− 1 3 2 6
# Labs 1 1 1 1

Mean 1.73 1.70 3.99 3.91 7.73 7.65
SD
CV
1 0.143
8.3
0.192
11.3
2 0.409
10.3
0.426
10.9
3 0.963
12.5
0.776
10.1
# Points 152 591 142 481 117 367
# Labs 7 11 7 11 5 8
Siemens ADVIA Centaur Systems • Siemens Centaur Testosterone (TSTO)

Mean 1.77 1.80 3.97 4.11 7.58 7.73
SD
CV
1 0.099
5.6
0.172
9.6
2
0.318
8.0
0.458
11.2
3 0.580
7.6
0.823
10.6
# Points 61 168 80 165 60 144
# Labs 2 2 2 2 2 2
Siemens ADVIA Centaur Systems • Siemens Centaur Testosterone II (TSTII)

Mean 1.82 1.84 4.11 4.19 7.64 7.76
SD
CV
1 0.131
7.2
0.144
7.8
2
0.308
7.5
0.328
7.8
3 0.655
8.6
0.732
9.4
# Points 294 1057 280 1050 287 1064
# Labs 13 14 13 14 13 14

Mean 1.68 1.68 4.18 4.16 7.66 7.51
SD
CV
1 0.085
5.0
0.082
4.9
2 0.228
5.5
0.235
5.7
3 0.407
5.3
0.475
6.3
# Points 429 1768 441 1780 415 1659
# Labs 14 15 14 15 14 14

Mean 1.20 1.17 4.77 4.72 10.34 10.18
SD
CV
1 0.165
13.8
0.153
13.1
2 0.485
10.2
0.492
10.4
3 0.998
9.7
1.08
10.6
# Points 93 215 99 220 71 171
# Labs 6 7 7 7 6 6

Mean 1.24 1.27 3.41 3.43 6.16 6.20
SD
CV
1 0.122
9.8
0.126
9.9
2 0.173
5.1
0.233
6.8
3 0.278
4.5
0.401
6.5
# Points 122 293 120 287 121 287
# Labs 5 8 5 8 5 7

Mean 1.10 1.10 4.95 4.95 11.78 11.83
SD
CV
1 0.075
6.9
0.068
6.2
2 0.278
5.6
0.268
5.4
3 0.595
5.1
0.555
4.7
# Points 687 3535 588 2959 591 3038
# Labs 39 45 35 40 35 40

Mean 1.56 1.51 4.12 4.17 8.56 8.70
SD
CV
1 0.351
22.4
0.364
24.2
2 0.550
13.4
0.566
13.6
3 1.71
20.0
1.90
21.8
# Points 4283 16012 3941 14258 3867 14381
# Labs 185 220 174 204 179 206
Testosterone EIA ng/dL

Mean −− 191.7 −− 428.8 −− −−
SD
CV
1 −−
−−
6.53
3.4
2 −−
−−
14.84
3.5
3 −−
−−
−−
−−
# Points −− 29 −− 30 −− −−
# Labs 1 1
Tosoh AIA Models

Mean 110.0 111.4 467.9 480.4 1162 1165
SD
CV
1 6.04
5.5
5.57
5.0
2 18.78
4.0
22.20
4.6
3 51.97
4.5
44.68
3.8
# Points 34 84 26 74 34 80
# Labs 2 3 2 3 2 3

Mean 110.0 132.0 467.9 465.5 1162 1165
SD
CV
1 6.04
5.5
35.74
27.1
2 18.78
4.0
31.02
6.7
3 51.97
4.5
44.68
3.8
# Points 34 113 26 104 34 80
# Labs 2 4 2 4 2 3
Testosterone EIA ng/mL

Mean −− 1.92 −− 4.29 −− −−
SD
CV
1 −−
−−
0.065
3.4
2 −−
−−
0.148
3.5
3 −−
−−
−−
−−
# Points −− 29 −− 30 −− −−
# Labs 1 1
Tosoh AIA Models

Mean 1.10 1.11 4.68 4.80 11.62 11.65
SD
CV
1 0.060
5.5
0.056
5.0
2 0.188
4.0
0.222
4.6
3 0.520
4.5
0.447
3.8
# Points 34 84 26 74 34 80
# Labs 2 3 2 3 2 3

Mean 1.10 1.32 4.68 4.66 11.62 11.65
SD
CV
1 0.060
5.5
0.357
27.1
2 0.188
4.0
0.310
6.7
3 0.520
4.5
0.447
3.8
# Points 34 113 26 104 34 80
# Labs 2 4 2 4 2 3
Testosterone Electrochemiluminescence (ECL) ng/dL

Mean 152.6 151.6 426.6 427.1 853.6 851.8
SD
CV
1 9.38
6.1
9.70
6.4
2 24.20
5.7
26.32
6.2
3 43.51
5.1
51.54
6.1
# Points 555 1717 689 2188 553 1743
# Labs 35 38 38 41 36 38
Roche cobas c 303/503 • Roche Elecsys Testosterone II, REF 07027915

Mean 148.7 147.2 411.7 406.7 820.6 811.8
SD
CV
1 3.70
2.5
3.77
2.6
8.922
2.2
10.10
2.5
3 20.14
2.5
18.12
2.2
# Points 27 60 27 61 27 64
# Labs 1 1 1 1 1 1

Mean 153.4 151.1 425.3 421.1 840.5 839.1
SD
CV
1 8.22
5.4
8.42
5.6
2 22.29
5.2
21.89
5.2
3 36.43
4.3
36.02
4.3
# Points 491 1238 374 1000 253 568
# Labs 20 20 17 17 15 15
Testosterone Electrochemiluminescence (ECL) ng/dL

Roche cobas e 402/801 • Roche Elecsys Testosterone II, REF 07027915
Mean 155.0 152.8 421.7 416.9 854.0 837.1
SD
CV
1 6.20
4.0
7.32
4.8
2
16.48
3.9
17.98
4.3
3 31.48
3.7
41.81
5.0
# Points 208 753 111 380 122 454
# Labs 8 9 5 6 5 6

Mean 5188 2159 14313 6028 850.5 839.3
SD
CV
1 6975
134.4
5027
232.8
2
19597 14108
136.9 234.0
3 37.71
4.4
40.29
4.8
# Points 81 246 65 218 58 221
# Labs 4 6 4 6 3 5
Roche cobas u 601

Mean 152.6 153.3 432.0 426.4 825.6 824.7
SD
CV
1 9.94
6.5
7.11
4.6
2 34.54
8.0
21.52
5.0
3 51.67
6.3
30.16
3.7
# Points 5 12 5 13 4 12
# Labs 1 1 1 1 1 1

Mean 155.6 155.0 429.3 419.1 853.6 854.4
SD
CV
1 14.06
9.0
12.86
8.3
2 24.52
5.7
67.86
16.2
3 49.95
5.9
60.27
7.1
# Points 388 1103 373 1073 291 798
# Labs 26 29 25 28 20 24

Mean 160.9 157.9 454.7 438.5 878.3 861.8
SD
CV
1 10.98
6.8
10.00
6.3
2 19.91
4.4
22.20
5.1
3 28.23
3.2
33.54
3.9
# Points 18 57 17 60 17 54
# Labs 1 1 1 1 1 1
Roche Elecsys / cobas e 411 Series • Roche ECL Testosterone II REF 08946353
Mean 165.8 154.8 458.9 431.7 890.7 839.8
SD
CV
1 10.71
6.5
9.64
6.2
2
18.92
4.1
20.74
4.8
3 30.53
3.4
36.04
4.3
# Points 21 132 21 130 20 129
# Labs 1 1 1 1 1 1

Mean 113.4 113.3 503.4 511.9 1152 1179
SD
CV
1 7.42
6.5
5.62
5.0
2 22.23
4.4
20.74
4.1
3 34.83
3.0
51.74
4.4
# Points 7 14 4 11 4 8
# Labs 1 1 1 1 1 1

Mean 380.2 245.0 962.6 661.5 852.0 847.9
SD
CV
1 1803
474.2
1157
472.3
2 4663
484.4
3113
470.6
3 45.77
5.4
51.73
6.1
# Points 1801 5332 1686 5134 1349 4051
# Labs 98 107 94 103 84 93
Testosterone Electrochemiluminescence (ECL) ng/mL

Mean 1.53 1.52 4.27 4.27 8.54 8.52
SD
CV
1 0.094
6.1
0.097
6.4
2 0.242
5.7
0.263
6.2
3 0.435
5.1
0.515
6.1
# Points 555 1717 689 2188 553 1743
# Labs 35 38 38 41 36 38
Roche cobas c 303/503 • Roche Elecsys Testosterone II, REF 07027915

Mean 1.49 1.47 4.12 4.07 8.21 8.12
SD
CV
1 0.037
2.5
0.038
2.6
2
0.089
2.2
0.101
2.5
3 0.201
2.5
0.181
2.2
# Points 27 60 27 61 27 64
# Labs 1 1 1 1 1 1
Testosterone Electrochemiluminescence (ECL) ng/mL

Mean 1.53 1.51 4.25 4.21 8.40 8.39
SD
CV
1 0.082
5.4
0.084
5.6
2 0.223
5.2
0.219
5.2
3 0.364
4.3
0.360
4.3
# Points 491 1238 374 1000 253 568
# Labs 20 20 17 17 15 15

Mean 1.55 1.53 4.22 4.17 8.54 8.37
SD
CV
1 0.062
4.0
0.073
4.8
0.1652
3.9
0.180
4.3
3 0.315
3.7
0.418
5.0
# Points 208 753 111 380 122 454
# Labs 8 9 5 6 5 6

Mean 51.88 21.59 143.1 60.28 8.51 8.39
SD
CV
1 69.75
134.4
50.27
232.8
196.0
136.9
2 141.1
234.0
3 0.377
4.4
0.403
4.8
# Points 81 246 65 218 58 221
# Labs 4 6 4 6 3 5
Roche cobas u 601

Mean 1.53 1.53 4.32 4.26 8.26 8.25
SD
CV
1 0.099
6.5
0.071
4.6
2 0.345
8.0
0.215
5.0
3 0.517
6.3
0.302
3.7
# Points 5 12 5 13 4 12
# Labs 1 1 1 1 1 1

Mean 1.56 1.55 4.29 4.19 8.54 8.54
SD
CV
1 0.141
9.0
0.129
8.3
2 0.245
5.7
0.679
16.2
3 0.500
5.9
0.603
7.1
# Points 388 1103 373 1073 291 798
# Labs 26 29 25 28 20 24

Mean 1.61 1.58 4.55 4.38 8.78 8.62
SD
CV
1 0.110
6.8
0.100
6.3
2 0.199
4.4
0.222
5.1
3 0.282
3.2
0.335
3.9
# Points 18 57 17 60 17 54
# Labs 1 1 1 1 1 1
Roche Elecsys / cobas e 411 Series • Roche ECL Testosterone II REF 08946353
Mean 1.66 1.55 4.59 4.32 8.91 8.40
SD
CV
1 0.107
6.5
0.096
6.2
0.189
4.1
2 0.207
4.8
3 0.305
3.4
0.360
4.3
# Points 21 132 21 130 20 129
# Labs 1 1 1 1 1 1

Mean 1.13 1.13 5.03 5.12 11.52 11.79
SD
CV
1 0.074
6.5
0.056
5.0
2 0.222
4.4
0.207
4.1
3 0.348
3.0
0.517
4.4
# Points 7 14 4 11 4 8
# Labs 1 1 1 1 1 1

Mean 3.80 2.45 9.63 6.62 8.52 8.48
SD
CV
1 18.03
474.2
11.57
472.3
2 46.63
484.4
31.13
470.6
3 0.458
5.4
0.517
6.1
# Points 1801 5332 1686 5134 1349 4051
# Labs 98 107 94 103 84 93
Testosterone FIA ng/dL

Mean 147.0 140.5 401.0 411.0 −− 797.0
SD
CV
1 0.000
0.0
8.19
5.8
2 25.00
6.2
31.12
7.6
3 −−
−−
9.00
1.1
# Points 1 4 4 5 −− 2
# Labs 1 1 1 1 1
Testosterone FIA ng/dL

Mean 147.0 140.5 401.0 411.0 −− 797.0
SD
CV
1 0.000
0.0
8.19
5.8
2 25.00
6.2
31.12
7.6
3 −−
−−
9.00
1.1
# Points 1 4 4 5 −− 2
# Labs 1 1 1 1 1
Testosterone FIA ng/mL

Mean 1.47 1.41 4.01 4.11 −− 7.97
SD
CV
1 0.000
0.0
0.082
5.8
2 0.250
6.2
0.311
7.6
3 −−
−−
0.090
1.1
# Points 1 4 4 5 −− 2
# Labs 1 1 1 1 1

Mean 1.47 1.41 4.01 4.11 −− 7.97
SD
CV
1 0.000
0.0
0.082
5.8
2 0.250
6.2
0.311
7.6
3 −−
−−
0.090
1.1
# Points 1 4 4 5 −− 2
# Labs 1 1 1 1 1
Testosterone, Free Chemiluminescence pg/mL

Snibe MAGLUMI
Mean −− 6.53 −− 18.96 −− 39.09
SD
CV
1 −−
−−
0.616
9.4
2 −−
−−
1.77
9.3
3 −−
−−
2.32
5.9
# Points −− 20 −− 18 −− 18
# Labs 1 1 1

Mean 6.58 6.60 19.01 18.63 38.81 38.88
SD
CV
1 0.555
8.4
0.544
8.2
2 1.06
5.6
1.06
5.7
3 1.54
4.0
1.36
3.5
# Points 264 1273 270 1295 235 1215
# Labs 8 8 8 8 6 7
Snibe MAGLUMI Series • Snibe MAGLUMI free Testosterone REF 130X02011M

Mean 5.62 5.45 16.28 16.14 −− −−
SD
CV
1 0.341
6.1
0.641
11.8
0.832
5.1
2 1.16
7.2
3 −−
−−
−−
−−
# Points 11 32 10 31 −− −−
# Labs 1 1 1 1

Mean 6.54 6.57 18.91 18.58 38.81 38.89
SD
CV
1 0.579
8.9
0.575
8.8
2 1.17
6.2
1.14
6.1
3 1.54
4.0
1.38
3.5
# Points 275 1325 280 1344 235 1233
# Labs 9 10 9 10 6 8
Testosterone, Free EIA pg/mL

DRG International, Inc.
Mean 2.30 1.92 10.25 9.95 30.06 23.46
SD
CV
1 0.000
0.0
0.229
12.0
2 0.000
0.0
1.33
13.3
3 0.000
0.0
3.76
16.0
# Points 1 40 1 40 1 39
# Labs 1 2 1 2 1 2

Mean 2.30 1.92 10.25 9.95 30.06 23.46
SD
CV
1 0.000
0.0
0.229
12.0
2 0.000
0.0
1.33
13.3
3 0.000
0.0
3.76
16.0
# Points 1 40 1 40 1 39
# Labs 1 2 1 2 1 2
Theophylline Chemiluminescence µg/mL

Mean 4.25 4.28 12.51 12.89 23.65 23.94
SD
CV
1 0.282
6.6
0.197
4.6
2 0.314
2.5
0.583
4.5
3 1.10
4.7
0.913
3.8
# Points 4 19 4 17 6 23
# Labs 2 2 2 2 2 2

Mean −− 4.44 −− 14.12 −− 25.38
SD
CV
1 −−
−−
0.033
0.7
2 −−
−−
0.014
0.1
3 −−
−−
0.700
2.8
# Points −− 2 −− 2 −− 2
# Labs 1 1 1

Mean 4.25 4.30 12.51 13.02 23.65 24.05
SD
CV
1 0.282
6.6
0.193
4.5
2 0.314
2.5
0.673
5.2
3 1.10
4.7
0.972
4.0
# Points 4 21 4 19 6 25
# Labs 2 3 2 3 2 3
Theophylline EIA µg/mL

Mean 4.13 4.13 13.93 13.93 25.22 25.22
SD
CV
1 0.151
3.6
0.151
3.6
2 0.388
2.8
0.388
2.8
3 0.319
1.3
0.319
1.3
# Points 6 6 6 6 6 6
# Labs 1 1 1 1 1 1

Mean 4.40 4.36 13.56 13.69 24.41 25.40
SD
CV
1 0.340
7.7
0.324
7.4
2 1.12
8.2
1.01
7.4
3 2.49
10.2
2.79
11.0
# Points 108 351 77 188 109 351
# Labs 3 3 2 2 3 3

Mean 4.39 4.35 13.58 13.69 24.45 25.40
SD
CV
1 0.338
7.7
0.323
7.4
2 1.08
8.0
0.994
7.3
3 2.43
9.9
2.77
10.9
# Points 114 357 83 194 115 357
# Labs 4 4 3 3 4 4
Theophylline Enzymetric µg/mL

Mean −− 4.31 −− 13.75 −− 26.90
SD
CV
1 −−
−−
0.206
4.8
2 −−
−−
0.415
3.0
3 −−
−−
0.689
2.6
# Points −− 113 −− 114 −− 116
# Labs 1 1 1
Method Group • Enzymetric

Mean −− 4.31 −− 13.75 −− 26.90
SD
CV
1 −−
−−
0.206
4.8
2 −−
−−
0.415
3.0
3 −−
−−
0.689
2.6
# Points −− 113 −− 114 −− 116
# Labs 1 1 1
Theophylline Immunoturbidimetric µg/mL

Mean 4.79 4.79 14.95 14.95 27.82 27.82
SD
CV
1 0.169
3.5
0.169
3.5
2 0.424
2.8
0.424
2.8
3 0.726
2.6
0.726
2.6
# Points 21 21 21 21 21 21
# Labs 1 1 1 1 1 1
Theophylline Immunoturbidimetric µg/mL

Mean 4.31 4.50 13.84 14.10 25.49 25.83
SD
CV
1 0.167
3.9
0.205
4.6
2 0.541
3.9
0.429
3.0
3 0.927
3.6
0.739
2.9
# Points 27 257 28 224 26 209
# Labs 1 1 1 1 1 1

Mean 3.88 3.94 −− −− 25.46 25.49
SD
CV
1 0.001
0.0
0.064
1.6
2 −−
−−
−−
−−
3 0.000
0.0
0.035
0.1
# Points 2 4 −− −− 2 4
# Labs 1 1 1 1

Mean 4.49 4.51 14.32 14.17 26.49 26.00
SD
CV
1 0.312
6.9
0.226
5.0
2 0.738
5.2
0.490
3.5
3 1.43
5.4
0.929
3.6
# Points 50 282 49 245 49 234
# Labs 3 3 2 2 3 3
Theophylline KIMS (Roche) µg/mL

Mean 4.60 4.52 14.30 13.98 26.33 25.96
SD
CV
1 0.140
3.0
0.185
4.1
2 0.340
2.4
0.456
3.3
3 0.550
2.1
0.811
3.1
# Points 93 998 92 995 93 998
# Labs 1 2 1 2 1 2

Mean 4.88 4.86 −− −− 27.47 27.37
SD
CV
1 0.186
3.8
0.188
3.9
2 −−
−−
−−
−−
3 0.603
2.2
0.619
2.3
# Points 32 58 −− −− 32 57
# Labs 1 1 1 1

Mean 4.67 4.54 14.30 13.98 26.62 26.04
SD
CV
1 0.195
4.2
0.201
4.4
2 0.340
2.4
0.456
3.3
3 0.750
2.8
0.863
3.3
# Points 125 1056 92 995 125 1055
# Labs 2 3 1 2 2 3
Thyroglobulin Chemiluminescence ng/mL

Mean 5.22 6.23 6.86 6.63 6.60 6.65
SD
CV
1 0.170
3.3
1.50
24.1
2 0.266
3.9
0.470
7.1
3 0.353
5.4
0.354
5.3
# Points 13 34 31 79 43 81
# Labs 1 1 2 2 2 2
Mindray CL Series
Mean −− −− 1.75 1.76 −− −−
SD
CV
1 −−
−−
−−
−−
2 0.140
8.0
0.126
7.1
3 −−
−−
−−
−−
# Points −− −− 13 50 −− −−
# Labs 1 1

Mean 1.37 1.39 1.62 1.68 1.90 1.88
SD
CV
1 0.305
22.3
0.317
22.9
2 0.277
17.1
0.347
20.6
3 0.336
17.7
0.336
17.9
# Points 56 163 59 145 56 155
# Labs 4 4 4 4 4 4
Thyroglobulin Chemiluminescence ng/mL

Mean 2.09 2.22 3.22 3.12 3.94 3.52
SD
CV
1 1.54
73.7
1.96
88.2
2 2.42
75.2
2.26
72.4
3 2.37
60.1
2.29
65.2
# Points 69 197 103 274 99 236
# Labs 5 5 7 7 6 6
Thyroglobulin Electrochemiluminescence (ECL) ng/mL

Mean 6.88 7.01 8.79 9.19 9.24 9.25
SD
CV
1 0.690
10.0
1.07
15.3
2 0.915
10.4
4.46
48.5
3 0.932
10.1
0.740
8.0
# Points 93 266 76 236 81 192
# Labs 13 13 6 7 6 6

Mean 6.67 6.79 8.78 8.90 9.21 9.56
SD
CV
1 0.275
4.1
0.307
4.5
2 0.336
3.8
0.376
4.2
3 0.345
3.7
0.429
4.5
# Points 69 246 70 243 93 564
# Labs 4 4 4 4 5 5
Roche cobas e 402/801 • Roche Elecsys Tg II, REF 08906564

Mean −− −− 9.18 9.39 9.43 9.64
SD
CV
1 −−
−−
−−
−−
0.180
2.0
2 0.237
2.5
3 0.220
2.3
0.240
2.5
# Points −− −− 19 61 18 60
# Labs 1 1 1 1

Mean 6.91 7.05 9.52 9.19 9.61 9.52
SD
CV
1 0.417
6.0
0.466
6.6
2 0.675
7.1
0.601
6.5
3 0.461
4.8
0.530
5.6
# Points 23 140 42 120 43 201
# Labs 3 4 4 4 4 4

Mean 6.81 6.93 8.97 9.10 9.31 9.50
SD
CV
1 0.546
8.0
0.749
10.8
2 0.724
8.1
2.69
29.6
3 0.640
6.9
0.527
5.6
# Points 185 652 207 660 235 1017
# Labs 20 21 15 16 16 16
Thyroglobulin (Tg) Ab, Total Chemiluminescence IU/mL

Mean 33.41 33.08 28.79 27.19 25.06 25.09
SD
CV
1 2.03
6.1
2.54
7.7
2 1.40
4.9
2.56
9.4
3 0.973
3.9
0.832
3.3
# Points 93 166 27 83 19 49
# Labs 5 6 2 3 2 2

Mean 55.58 48.50 118.6 110.4 266.4 253.3
SD
CV
1 3.42
6.2
8.05
16.6
2 10.15
8.6
9.05
8.2
3 19.41
7.3
17.59
6.9
# Points 2 18 2 18 2 18
# Labs 1 1 1 1 1 1

Mean −− −− 24.94 24.61 22.47 22.61
SD
CV
1 −−
−−
−−
−−
2 1.56
6.3
1.78
7.2
3 1.06
4.7
1.21
5.4
# Points −− −− 61 227 30 48
# Labs 3 3 1 1
Thyroglobulin (Tg) Ab, Total Chemiluminescence IU/mL

Mean 50.55 68.80 39.65 55.13 31.97 42.39
SD
CV
1 0.000
0.0
13.64
19.8
2 13.40
33.8
28.44
51.6
3 7.33
22.9
18.78
44.3
# Points 1 6 2 3 2 3
# Labs 1 1 1 1 1 1
Mindray CL Series
Mean −− −− 17.57 17.64 −− −−
SD
CV
1 −−
−−
−−
−−
2 0.510
2.9
0.511
2.9
3 −−
−−
−−
−−
# Points −− −− 43 200 −− −−
# Labs 2 2

Mean 39.73 45.09 80.34 88.14 −− −−
SD
CV
1 2.86
7.2
5.30
11.8
2 4.38
5.5
8.36
9.5
3 −−
−−
−−
−−
# Points 32 323 32 323 −− −−
# Labs 1 1 1 1
Siemens Atellica IM Analyzer • Siemens Atellica IM aTgII REF 11201759/61

Mean 24.57 24.89 −− −− −− −−
SD
CV
1 1.30
5.3
2.20
8.8
2 −−
−−
−−
−−
3 −−
−−
−−
−−
# Points 5 114 −− −− −− −−
# Labs 1 1
YHLO iFlash 3000

Mean −− −− 117.8 117.8 −− −−
SD
CV
1 −−
−−
−−
−−
2 4.45
3.8
4.45
3.8
3 −−
−−
−−
−−
# Points −− −− 20 20 −− −−
# Labs 1 1
Thyroglobulin (Tg) Ab, Total Electrochemiluminescence (ECL) IU/mL

Mean 71.28 58.39 50.01 59.39 60.90 60.90
SD
CV
1 12.85
18.0
13.22
22.6
2 1.70
3.4
15.74
26.5
3 6.83
11.2
6.83
11.2
# Points 31 79 8 87 22 22
# Labs 2 2 1 2 1 1
Roche cobas 6000/8000/c 311 • Roche Elecsys Anti−Tg REF 06368697

Mean 7.06 7.06 9.07 9.07 9.32 9.32
SD
CV
1 0.321
4.5
0.321
4.5
2
0.279
3.1
0.279
3.1
3 0.160
1.7
0.160
1.7
# Points 5 5 3 3 4 4
# Labs 1 1 1 1 1 1

Mean 61.42 62.64 −− −− 46.22 47.20
SD
CV
1 4.15
6.8
4.70
7.5
2 −−
−−
−−
−−
3 3.45
7.5
3.50
7.4
# Points 108 403 −− −− 105 362
# Labs 4 4 4 4

Mean 55.58 66.30 47.64 54.37 40.12 46.02
SD
CV
1 9.61
17.3
5.79
8.7
2 3.18
6.7
13.71
25.2
3 2.94
7.3
4.73
10.3
# Points 3 40 3 4 4 68
# Labs 1 2 1 2 2 2
Thyroperoxidase (TPO) Ab, Total Chemiluminescence IU/mL

Mean 45.57 45.66 35.70 36.49 30.98 32.02
SD
CV
1 2.87
6.3
2.79
6.1
2 1.56
4.4
1.76
4.8
3 1.38
4.5
1.86
5.8
# Points 94 174 29 86 28 58
# Labs 5 6 2 3 2 2

Mean 14.91 14.39 47.56 46.28 110.3 110.9
SD
CV
1 0.600
4.0
0.674
4.7
2 4.92
10.3
2.27
4.9
3 9.25
8.4
10.70
9.7
# Points 2 18 2 18 2 18
# Labs 1 1 1 1 1 1

Mean −− −− 22.15 24.25 16.84 17.31
SD
CV
1 −−
−−
−−
−−
2 2.89
13.1
4.07
16.8
3 0.960
5.7
1.24
7.2
# Points −− −− 63 232 31 49
# Labs 3 3 1 1
Mindray CL Series
Mean −− 35.79 25.30 25.95 −− −−
SD
CV
1 −−
−−
2.05
5.7
2 1.55
6.1
1.58
6.1
3 −−
−−
−−
−−
# Points −− 71 35 261 −− −−
# Labs 1 2 3

Mean −− −− −− 176.0 −− −−
SD
CV
1 −−
−−
−−
−−
2 −−
−−
15.88
9.0
3 −−
−−
−−
−−
# Points −− −− −− 3 −− −−
# Labs 1

Mean 61.26 50.48 −− 170.3 −− −−
SD
CV
1 8.00
13.1
9.76
19.3
2 −−
−−
13.79
8.1
3 −−
−−
−−
−−
# Points 66 648 −− 479 −− −−
# Labs 2 2 2
YHLO iFlash 3000

Mean −− −− 30.50 30.50 −− −−
SD
CV
1 −−
−−
−−
−−
2 1.03
3.4
1.03
3.4
3 −−
−−
−−
−−
# Points −− −− 39 39 −− −−
# Labs 1 1
Thyroperoxidase (TPO) Ab, Total Chemiluminescence U/mL

Mean 45.57 45.66 35.70 36.49 30.98 32.02
SD
CV
1 2.87
6.3
2.79
6.1
2 1.56
4.4
1.76
4.8
3 1.38
4.5
1.86
5.8
# Points 94 174 29 86 28 58
# Labs 5 6 2 3 2 2

Mean 14.91 14.39 47.56 46.28 110.3 110.9
SD
CV
1 0.600
4.0
0.674
4.7
2 4.92
10.3
2.27
4.9
3 9.25
8.4
10.70
9.7
# Points 2 18 2 18 2 18
# Labs 1 1 1 1 1 1

Mean −− −− 22.15 24.25 16.84 17.31
SD
CV
1 −−
−−
−−
−−
2 2.89
13.1
4.07
16.8
3 0.960
5.7
1.24
7.2
# Points −− −− 63 232 31 49
# Labs 3 3 1 1
Thyroperoxidase (TPO) Ab, Total Chemiluminescence U/mL

Mindray CL Series
Mean −− 35.79 25.30 25.95 −− −−
SD
CV
1 −−
−−
2.05
5.7
2 1.55
6.1
1.58
6.1
3 −−
−−
−−
−−
# Points −− 71 35 261 −− −−
# Labs 1 2 3

Mean −− −− −− 176.0 −− −−
SD
CV
1 −−
−−
−−
−−
2 −−
−−
15.88
9.0
3 −−
−−
−−
−−
# Points −− −− −− 3 −− −−
# Labs 1

Mean 61.26 50.48 −− 170.3 −− −−
SD
CV
1 8.00
13.1
9.76
19.3
2 −−
−−
13.79
8.1
3 −−
−−
−−
−−
# Points 66 648 −− 479 −− −−
# Labs 2 2 2
YHLO iFlash 3000

Mean −− −− 30.50 30.50 −− −−
SD
CV
1 −−
−−
−−
−−
2 1.03
3.4
1.03
3.4
3 −−
−−
−−
−−
# Points −− −− 39 39 −− −−
# Labs 1 1
Thyroperoxidase (TPO) Ab, Total Electrochemiluminescence (ECL) IU/mL

Mean 33.39 30.60 29.25 33.07 29.48 29.48
SD
CV
1 3.86
11.6
3.62
11.8
2 2.29
7.8
7.45
22.5
3 2.78
9.4
2.78
9.4
# Points 30 79 8 87 21 21
# Labs 2 2 1 2 1 1

Mean 37.34 35.81 −− −− 27.57 26.91
SD
CV
1 2.32
6.2
3.61
10.1
2 −−
−−
−−
−−
3 1.91
6.9
3.15
11.7
# Points 84 306 −− −− 77 260
# Labs 3 3 3 3

Mean 34.39 32.47 33.23 33.37 27.88 25.34
SD
CV
1 3.37
9.8
3.62
11.1
2 2.23
6.7
2.98
8.9
3 4.39
15.8
3.76
14.8
# Points 9 55 9 17 10 82
# Labs 1 3 1 1 2 2
Thyroperoxidase (TPO) Ab, Total Electrochemiluminescence (ECL) U/mL

Mean 33.39 30.60 29.25 33.07 29.48 29.48
SD
CV
1 3.86
11.6
3.62
11.8
2 2.29
7.8
7.45
22.5
3 2.78
9.4
2.78
9.4
# Points 30 79 8 87 21 21
# Labs 2 2 1 2 1 1

Mean 37.34 35.81 −− −− 27.57 26.91
SD
CV
1 2.32
6.2
3.61
10.1
2 −−
−−
−−
−−
3 1.91
6.9
3.15
11.7
# Points 84 306 −− −− 77 260
# Labs 3 3 3 3
Thyroperoxidase (TPO) Ab, Total Electrochemiluminescence (ECL) U/mL

Mean 34.39 32.47 33.23 33.37 27.88 25.34
SD
CV
1 3.37
9.8
3.62
11.1
2 2.23
6.7
2.98
8.9
3 4.39
15.8
3.76
14.8
# Points 9 55 9 17 10 82
# Labs 1 3 1 1 2 2
TIBC (Total Iron Binding Capacity) Chromazurol B−VITROS µg/dL

Mean 309.9 287.6 260.4 247.6 259.9 245.8
SD
CV
1 6.36
2.1
19.46
6.8
2 7.50
2.9
8.68
3.5
3 10.43
4.0
14.15
5.8
# Points 10 41 8 39 10 41
# Labs 1 1 1 1 1 1
Method Group • Chromazurol B−VITROS

Mean 309.9 287.6 260.4 247.6 259.9 245.8
SD
CV
1 6.36
2.1
19.46
6.8
2 7.50
2.9
8.68
3.5
3 10.43
4.0
14.15
5.8
# Points 10 41 8 39 10 41
# Labs 1 1 1 1 1 1
Tobramycin EIA µg/mL

Beckman Coulter AU Series • Emit 2000 Tobramycin, REF OSR4S229
Mean 0.884 0.880 −− −− 5.93 5.72
SD
CV
1 0.063
7.1
0.103
11.7
−−
−−
2 −−
−−
3 0.216
3.6
0.265
4.6
# Points 32 267 −− −− 32 262
# Labs 1 1 1 1

Mean 0.822 0.831 −− −− 5.33 5.38
SD
CV
1 0.096
11.7
0.111
13.3
2 −−
−−
−−
−−
3 0.195
3.7
0.230
4.3
# Points 32 58 −− −− 31 56
# Labs 1 1 1 1

Mean 0.853 0.871 −− −− 5.64 5.66
SD
CV
1 0.086
10.1
0.106
12.1
2 −−
−−
−−
−−
3 0.368
6.5
0.290
5.1
# Points 64 325 −− −− 63 318
# Labs 2 2 2 2
Tobramycin Immunoturbidimetric µg/mL

Mean 0.800 0.800 2.56 2.56 5.18 5.18
SD
CV
1 0.000
0.0
0.000
0.0
2 0.055
2.1
0.055
2.1
3 0.045
0.9
0.045
0.9
# Points 5 5 5 5 5 5
# Labs 1 1 1 1 1 1

Mean 0.490 0.510 2.24 2.29 4.85 4.93
SD
CV
1 0.095
19.3
0.103
20.2
2 0.082
3.7
0.097
4.2
3 0.141
2.9
0.137
2.8
# Points 67 432 66 422 63 399
# Labs 2 2 2 2 2 2

Mean −− 0.514 −− −− 4.84 4.75
SD
CV
1 −−
−−
0.073
14.3
2 −−
−−
−−
−−
3 0.000
0.0
0.089
1.9
# Points −− 6 −− −− 2 6
# Labs 1 1 1
Tobramycin Immunoturbidimetric µg/mL

Mean 0.511 0.513 2.26 2.29 4.87 4.93
SD
CV
1 0.121
23.6
0.106
20.7
2 0.115
5.1
0.101
4.4
3 0.159
3.3
0.140
2.8
# Points 72 443 71 427 70 410
# Labs 3 4 3 3 4 4
TSH Chemiluminescence µIU/mL

1drop
Mean 0.300 0.292 −− −− −− 27.78
SD
CV
1 0.020
6.7
0.021
7.2
2 −−
−−
−−
−−
3 −−
−−
1.49
5.4
# Points 33 297 −− −− −− 251
# Labs 1 1 1

Mean 0.414 0.416 4.03 4.04 25.89 25.96
SD
CV
1 0.024
5.8
0.026
6.4
2 0.188
4.7
0.190
4.7
3 1.18
4.5
1.20
4.6
# Points 4006 13080 3752 11634 3656 11884
# Labs 130 148 119 133 124 138

Mean 0.500 0.500 5.22 5.22 −− −−
SD
CV
1 0.000
0.0
0.000
0.0
2
0.000
0.0
0.000
0.0
3 −−
−−
−−
−−
# Points 1 1 1 1 −− −−
# Labs 1 1 1 1
Abbott ARCHITECT/Alinity (c, i, ci models) • Abbott Alinity i TSH, REF 07P48

Mean 0.393 0.392 3.95 3.95 26.48 26.26
SD
CV
1 0.011
2.9
0.010
2.5
2 0.141
3.6
0.112
2.8
3 0.894
3.4
0.931
3.5
# Points 16 37 17 37 16 36
# Labs 2 2 2 2 2 2

Mean 0.412 0.413 4.14 4.15 −− 26.84
SD
CV
1 0.018
4.4
0.016
3.8
2
0.118
2.9
0.105
2.5
3 −−
−−
0.208
0.8
# Points 26 74 26 51 −− 23
# Labs 1 1 1 1 1
Abbott ARCHITECT/Alinity (c, i, ci models) • TSH, WHO 3rd IS 81/565

Mean −− −− −− 3.82 −− 26.20
SD
CV
1 −−
−−
−−
−−
2 −−
−−
0.000
0.0
3 −−
−−
0.000
0.0
# Points −− −− −− 1 −− 1
# Labs 1 1

Mean 0.526 0.533 4.78 4.84 30.89 32.35
SD
CV
1 0.059
11.2
0.043
8.0
2 0.403
8.4
0.426
8.8
3 3.67
11.9
3.24
10.0
# Points 16 34 39 109 39 95
# Labs 2 2 3 4 3 4
Beckman Coulter Access, LXi 725, DxC 600i IA Systems • BC Access/DxI TSH (3rd IS) REF B63284/C28643
Mean 0.446 0.454 4.92 4.83 31.49 31.78
SD
CV
1 0.034
7.5
0.039
8.5
2
0.467
9.5
0.393
8.1
3 2.54
8.1
2.37
7.5
# Points 111 496 74 256 109 481
# Labs 6 7 4 4 6 7
Beckman Coulter Access, LXi 725, DxC 600i IA Systems • Beckman Coulter Access HYPERsensitive hTSH
Mean 0.466 0.441 4.82 4.80 31.94 31.63
SD
CV
1 0.027
5.9
0.042
9.5
2
0.262
5.4
0.246
5.1
3 1.63
5.1
2.11
6.7
# Points 115 877 100 411 113 914
# Labs 6 8 5 6 5 7

Beckman Coulter Access, LXi 725, DxC 600i IA Systems • TSH, WHO 3rd IS 81/565
Mean 0.454 0.455 4.71 4.75 31.95 32.36
SD
CV
1 0.032
6.9
0.030
6.5
0.267
5.7
2 0.320
6.7
3 2.13
6.7
2.26
7.0
# Points 225 714 219 674 188 625
# Labs 11 12 10 11 10 11

Mean −− −− −− 4.65 −− −−
SD
CV
1 −−
−−
−−
−−
2 −−
−−
0.143
3.1
3 −−
−−
−−
−−
# Points −− −− −− 120 −− −−
# Labs 1
Beckman Coulter UniCel DxI Series • 3rd IS

Mean 0.446 0.440 4.67 4.65 31.25 31.69
SD
CV
1 0.018
4.1
0.021
4.7
2 0.182
3.9
0.194
4.2
3 1.94
6.2
1.77
5.6
# Points 120 349 120 328 121 346
# Labs 5 5 5 5 5 5
Beckman Coulter UniCel DxI Series • Beckman Coulter Access FAST TSH
Mean −− 0.447 4.46 4.52 −− 31.04
SD
CV
1 −−
−−
0.021
4.8
0.102
2.3
2 0.194
4.3
3 −−
−−
1.59
5.1
# Points −− 113 4 100 −− 59
# Labs 3 1 4 4
Beckman Coulter UniCel DxI Series • Beckman Coulter Access HYPERsensitive hTSH
Mean 0.436 0.439 4.50 4.59 31.05 31.31
SD
CV
1 0.017
3.9
0.022
5.1
0.208
4.6
20.246
5.4
3 1.51
4.8
1.64
5.2
# Points 76 319 107 369 105 369
# Labs 4 4 5 5 5 5
Beckman Coulter UniCel DxI Series • TSH, WHO 3rd IS 81/565

Mean 0.442 0.441 4.65 4.62 31.33 31.00
SD
CV
1 0.030
6.7
0.027
6.1
0.364
7.8
2 0.302
6.5
3 1.89
6.0
1.95
6.3
# Points 518 1875 545 1757 575 2002
# Labs 27 32 25 31 28 33
DiaSorin LIAISON/XL
Mean 0.699 0.699 6.16 6.16 −− −−
SD
CV
1 0.021
3.0
0.021
3.0
2 0.930
15.1
0.930
15.1
3 −−
−−
−−
−−
# Points 6 6 5 5 −− −−
# Labs 2 2 2 2
Mindray CL Series
Mean 0.570 0.564 5.13 4.80 35.35 33.27
SD
CV
1 0.016
2.8
0.036
6.4
2 0.581
11.3
0.503
10.5
3 3.39
9.6
3.33
10.0
# Points 58 165 88 464 43 197
# Labs 3 4 5 7 4 4

Mean 0.541 0.547 5.00 5.06 −− −−
SD
CV
1 0.033
6.1
0.033
6.0
2 0.571
11.4
0.392
7.7
3 −−
−−
−−
−−
# Points 23 62 24 63 −− −−
# Labs 2 2 2 2
Siemens ADVIA Centaur CP • Siemens Centaur TSH with Cal CB91 and higher
Mean 0.391 0.382 4.15 4.09 27.91 27.07
SD
CV
1 0.029
7.5
0.030
7.7
0.275
6.6
20.291
7.1
3 1.83
6.6
1.82
6.7
# Points 25 67 24 76 21 69
# Labs 1 1 1 1 1 1

Siemens ADVIA Centaur CP • Siemens Centaur TSH, REF 08700387
Mean −− −− 5.08 4.91 36.40 34.90
SD
CV
1 −−
−−
−−
−−
2
0.442
8.7
0.469
9.6
3 4.92
13.5
5.22
14.9
# Points −− −− 22 34 19 32
# Labs 1 1 1 2
Siemens ADVIA Centaur CP • Siemens Centaur TSH3−Ultra, REF 06491080

Mean 0.391 0.401 4.01 4.13 27.94 28.30
SD
CV
1 0.042
10.7
0.039
9.7
2
0.377
9.4
0.391
9.5
3 2.34
8.4
2.71
9.6
# Points 94 191 93 191 93 190
# Labs 5 5 5 5 5 5

Mean 0.415 0.443 4.40 4.54 29.54 30.35
SD
CV
1 0.042
10.0
0.042
9.6
2 0.294
6.7
0.461
10.2
3 1.80
6.1
3.04
10.0
# Points 62 251 61 129 62 127
# Labs 2 4 2 3 2 3
Siemens ADVIA Centaur Systems • Siemens Centaur TSH with Cal CB91 and higher
Mean 0.446 0.432 4.57 4.49 30.66 30.13
SD
CV
1 0.021
4.7
0.020
4.7
0.1822
4.0
0.190
4.2
3 1.33
4.3
1.42
4.7
# Points 37 125 35 117 35 118
# Labs 2 2 2 2 2 2
Siemens ADVIA Centaur Systems • Siemens Centaur TSH, REF 08700387

Mean 0.500 0.520 5.23 5.34 36.08 36.28
SD
CV
1 0.090
17.9
0.076
14.6
2
0.799
15.3
0.699
13.1
3 6.04
16.7
5.08
14.0
# Points 115 578 119 557 116 566
# Labs 6 8 6 8 5 7
Siemens ADVIA Centaur Systems • Siemens Centaur TSH3−Ultra, REF 06491080

Mean 0.440 0.440 4.63 4.58 30.90 30.73
SD
CV
1 0.026
5.9
0.024
5.4
0.328
7.1
2 0.260
5.7
3 1.62
5.2
1.73
5.6
# Points 962 2774 1002 2725 784 1994
# Labs 37 39 36 37 35 36

Mean 0.444 0.447 4.73 4.72 31.53 31.61
SD
CV
1 0.027
6.1
0.026
5.7
2 0.390
8.2
0.288
6.1
3 1.97
6.2
1.71
5.4
# Points 857 2915 826 2619 707 2126
# Labs 24 24 20 20 21 21
Siemens Atellica IM Analyzer • Siemens Centaur TSH3−Ultra, REF 06491080

Mean 0.425 0.409 5.12 5.12 34.10 33.79
SD
CV
1 0.066
15.5
0.046
11.2
2
0.263
5.1
0.277
5.4
3 2.81
8.2
1.98
5.9
# Points 110 859 110 859 110 857
# Labs 4 4 4 4 4 4

Mean 0.463 0.470 4.83 4.86 35.03 35.22
SD
CV
1 0.030
6.5
0.032
6.8
2 0.248
5.1
0.257
5.3
3 2.33
6.7
2.38
6.7
# Points 312 1370 255 1175 202 710
# Labs 11 11 10 10 8 8

Mean 0.430 0.430 4.62 4.57 34.58 34.59
SD
CV
1 0.016
3.8
0.021
4.9
2 0.179
3.9
0.170
3.7
3 1.71
4.9
1.60
4.6
# Points 91 620 24 34 91 600
# Labs 3 3 1 1 3 3

Mean 0.465 0.623 4.70 4.88 29.51 30.99
SD
CV
1 0.044
9.6
0.661
106.2
2 0.478
10.2
0.530
10.8
3 3.64
12.3
3.86
12.5
# Points 89 244 88 241 87 241
# Labs 4 5 4 5 4 5
Siemens IMMULITE 2000/2500/XPi • Siemens IMMULITE Third Generation TSH, REF L2KTS
Mean 0.505 0.495 4.89 4.90 31.70 30.92
SD
CV
1 0.029
5.7
0.032
6.4
0.265
5.4
2
0.233
4.8
3 1.58
5.0
1.53
4.9
# Points 21 117 20 116 20 116
# Labs 1 1 1 1 1 1
Snibe MAGLUMI
Mean 0.546 0.536 4.75 4.83 35.51 35.40
SD
CV
1 0.026
4.8
0.029
5.4
2 0.296
6.2
0.252
5.2
3 1.21
3.4
1.10
3.1
# Points 5 21 10 18 13 21
# Labs 1 1 1 1 1 1

Mean 0.555 0.746 5.04 5.22 37.44 37.07
SD
CV
1 0.018
3.3
0.860
115.3
2 0.277
5.5
0.792
15.2
3 1.72
4.6
1.68
4.5
# Points 79 173 105 247 91 244
# Labs 7 10 7 11 6 8
Snibe MAGLUMI Series • Snibe MAGLUMI TSH REF 130X030XXM

Mean 0.549 0.570 4.94 5.11 33.91 35.03
SD
CV
1 0.054
9.8
0.061
10.7
0.196
4.0
2 0.281
5.5
3 1.27
3.7
1.89
5.4
# Points 14 23 14 24 14 23
# Labs 1 1 1 1 1 1
Tosoh AIA Models

Mean 0.464 0.484 4.68 5.10 29.51 32.40
SD
CV
1 0.017
3.6
0.050
10.4
2 0.166
3.5
0.474
9.3
3 0.873
3.0
2.87
8.9
# Points 21 182 21 181 21 178
# Labs 1 1 1 1 1 1

Mean 0.384 0.388 4.41 4.42 30.57 30.36
SD
CV
1 0.051
13.3
0.054
13.9
2 0.237
5.4
0.290
6.6
3 1.72
5.6
1.96
6.5
# Points 1401 6545 1261 5759 1317 6190
# Labs 54 60 48 55 50 54
VITROS Microwell Series • 3rd Generation

Mean 0.410 0.410 4.35 4.35 30.95 30.95
SD
CV
1 0.020
4.9
0.020
4.9
2 0.150
3.4
0.150
3.4
3 2.10
6.8
2.10
6.8
# Points 11 11 10 10 9 9
# Labs 1 1 1 1 1 1
VITROS Microwell Series • VITROS Microwell TSH3, REF 684 4466

Mean 0.410 0.391 4.43 4.39 31.12 30.27
SD
CV
1 0.028
7.0
0.051
13.1
0.357
8.1
2 0.313
7.1
3 2.15
6.9
2.05
6.8
# Points 331 1813 309 1722 335 1810
# Labs 16 22 16 21 17 22
YHLO iFlash 3000

Mean −− −− 6.44 6.44 43.12 43.12
SD
CV
1 −−
−−
−−
−−
2 0.140
2.2
0.140
2.2
3 0.840
1.9
0.840
1.9
# Points −− −− 38 38 38 38
# Labs 1 1 1 1

Mean 0.425 0.425 4.40 4.43 29.30 29.49
SD
CV
1 0.046
10.7
0.097
22.7
2 0.466
10.6
0.451
10.2
3 3.65
12.4
3.52
11.9
# Points 9961 37304 9542 33201 9150 33519
# Labs 383 436 358 409 362 409
TSH EIA µIU/mL

Mean 0.488 0.488 5.45 5.45 36.89 36.89
SD
CV
1 0.024
4.9
0.024
4.9
2 0.336
6.2
0.336
6.2
3 1.61
4.4
1.61
4.4
# Points 9 9 9 9 9 9
# Labs 1 1 1 1 1 1
Roche cobas c 303/503 • Roche TSH REF 08429324

Mean 0.568 0.561 5.44 5.42 36.44 36.29
SD
CV
1 0.020
3.5
0.020
3.6
2 0.205
3.8
0.173
3.2
3 1.41
3.9
1.22
3.4
# Points 28 64 28 64 28 64
# Labs 1 1 1 1 1 1

Mean 0.597 0.603 5.60 5.56 36.38 34.74
SD
CV
1 0.014
2.4
0.016
2.6
2 0.107
1.9
0.173
3.1
3 0.000
0.0
0.841
2.4
# Points 27 51 26 58 1 21
# Labs 1 1 1 1 1 1

Mean 0.469 0.459 5.07 4.92 −− 29.79
SD
CV
1 0.025
5.3
0.029
6.3
2 0.310
6.1
0.273
5.5
3 −−
−−
1.27
4.3
# Points 32 102 33 104 −− 38
# Labs 2 3 2 3 1
Tosoh AIA Models

Mean 0.499 0.495 5.19 5.00 32.98 33.40
SD
CV
1 0.025
5.0
0.030
6.1
2 0.219
4.2
0.311
6.2
3 0.887
2.7
1.34
4.0
# Points 48 277 48 258 23 76
# Labs 2 3 2 3 1 2
Tosoh AIA Models • Tosoh AIA TSH−3 REF 020294

Mean −− −− 4.53 4.74 28.57 29.86
SD
CV
1 −−
−−
−−
−−
2 0.125
2.8
0.353
7.4
3 0.690
2.4
1.84
6.1
# Points −− −− 4 6 3 5
# Labs 1 1 1 1
Tosoh AIA Models • Tosoh ST AIA TSH REF 025294

Mean −− 0.484 −− 4.68 −− 33.90
SD
CV
1 −−
−−
0.047
9.8
2 −−
−−
0.209
4.5
3 −−
−−
2.84
8.4
# Points −− 64 −− 4 −− 64
# Labs 2 1 2

Mean 0.523 0.504 5.28 5.10 34.89 33.84
SD
CV
1 0.053
10.2
0.051
10.2
2 0.324
6.1
0.360
7.1
3 2.53
7.2
2.72
8.1
# Points 144 567 148 503 64 277
# Labs 7 11 8 11 5 9
TSH Electrochemiluminescence (ECL) µIU/mL

Mindray CL Series
Mean 0.455 0.499 −− −− 30.28 31.90
SD
CV
1 0.008
1.8
0.041
8.1
2 −−
−−
−−
−−
3 0.556
1.8
1.46
4.6
# Points 23 140 −− −− 23 139
# Labs 1 1 1 1

Mean 0.568 0.570 5.31 5.30 35.06 34.97
SD
CV
1 0.022
3.8
0.022
3.9
2 0.233
4.4
0.213
4.0
3 1.44
4.1
1.32
3.8
# Points 678 3143 856 3922 819 3574
# Labs 31 40 35 43 34 39
Roche cobas 6000/8000/c 311 • Roche Elecsys TSH REF 08443432

Mean 0.581 0.584 5.44 5.44 36.07 35.99
SD
CV
1 0.012
2.1
0.017
2.9
0.091
1.7
2 0.103
1.9
3 0.620
1.7
0.756
2.1
# Points 190 474 191 432 187 414
# Labs 3 5 3 5 3 3
Roche cobas 6000/8000/c 311 • Roche TSH REF 08429324

Mean 0.563 0.566 5.27 5.24 34.71 34.51
SD
CV
1 0.020
3.6
0.021
3.6
0.216
4.1
2 0.231
4.4
3 1.35
3.9
1.41
4.1
# Points 442 1377 491 1777 459 1668
# Labs 19 19 18 18 18 18
Roche cobas 6000/8000/c 311 • Roche TSH REF 11731459

Mean 0.566 0.569 5.35 5.32 35.50 35.18
SD
CV
1 0.024
4.2
0.019
3.4
0.166
3.1
2 0.168
3.2
3 0.925
2.6
1.12
3.2
# Points 90 266 76 257 82 269
# Labs 4 4 3 3 4 4

Mean 0.528 0.538 4.98 5.02 33.70 34.43
SD
CV
1 0.031
5.8
0.031
5.9
2 0.283
5.7
0.249
5.0
3 1.49
4.4
1.52
4.4
# Points 760 2365 529 1666 550 2057
# Labs 24 28 15 19 21 25
Roche cobas e 402/801 • 3rd IS

Mean 0.554 0.556 −− −− 35.23 35.22
SD
CV
1 0.005
0.9
0.009
1.6
2 −−
−−
−−
−−
3 0.318
0.9
0.435
1.2
# Points 27 92 −− −− 27 67
# Labs 1 1 1 1
Roche cobas e 402/801 • Roche Elecsys TSH REF 08443432

Mean 0.528 0.529 5.00 5.04 34.75 34.59
SD
CV
1 0.024
4.5
0.022
4.1
0.215
4.3
2 0.202
4.0
3 1.05
3.0
1.07
3.1
# Points 1687 4746 1410 4242 290 609
# Labs 31 32 26 29 13 13
Mean 0.537 0.524 5.10 5.14 33.75 35.36
SD
CV
1 0.027
5.1
0.032
6.0
2
0.166
3.3
0.257
5.0
3 1.38
4.1
2.55
7.2
# Points 22 107 22 107 22 107
# Labs 1 1 1 1 1 1
Roche cobas e 402/801 • Roche TSH REF 08429324

Mean 0.460 0.466 5.82 5.81 37.05 37.05
SD
CV
1 0.010
2.2
0.011
2.4
2 0.060
1.0
0.059
1.0
3 0.330
0.9
0.410
1.1
# Points 15 35 15 35 15 35
# Labs 1 1 1 1 1 1
TSH Electrochemiluminescence (ECL) µIU/mL

Roche cobas e 402/801 • Roche TSH REF 11731459
Mean 0.529 0.529 5.09 5.11 −− 34.89
SD
CV
1 0.021
4.0
0.021
4.0
2 0.156
3.1
0.152
3.0
3 −−
−−
0.577
1.7
# Points 46 57 78 122 −− 26
# Labs 2 2 3 3 1
Roche cobas e 402/801 • Roche e 801 TSH REF 07028091

Mean 0.544 0.545 5.15 5.23 34.17 34.31
SD
CV
1 0.021
3.9
0.017
3.1
2 0.178
3.5
0.185
3.5
3 1.09
3.2
0.976
2.8
# Points 351 1306 62 226 354 1283
# Labs 9 12 4 7 9 12
Roche cobas u 601

Mean 0.560 0.560 5.37 5.35 36.10 35.65
SD
CV
1 0.010
1.8
0.014
2.4
2 0.190
3.5
0.146
2.7
3 0.560
1.6
0.741
2.1
# Points 16 38 18 41 17 40
# Labs 1 1 1 1 1 1

Mean 0.575 0.575 5.43 5.46 35.47 35.57
SD
CV
1 0.034
6.0
0.036
6.2
2 0.307
5.7
0.278
5.1
3 2.04
5.7
1.84
5.2
# Points 947 3265 1026 3306 911 2694
# Labs 53 58 56 60 51 56
Roche Elecsys / cobas e 411 Series • Alternate Calibration

Mean −− −− 5.55 5.49 36.73 37.29
SD
CV
1 −−
−−
−−
−−
2
0.122
2.2
0.323
5.9
3 0.545
1.5
0.777
2.1
# Points −− −− 7 20 7 20
# Labs 1 1 1 1
Roche Elecsys / cobas e 411 Series • Roche Elecsys TSH REF 08443432
Mean −− 0.580 −− 5.39 −− 35.09
SD
CV
1 −−
−−
0.030
5.2
2
−−
−−
0.247
4.6
3 −−
−−
1.68
4.8
# Points −− 144 −− 136 −− 137
# Labs 1 1 1
Roche Elecsys / cobas e 411 Series • Roche TSH REF 08429324

Mean 0.571 0.575 5.43 5.37 35.61 35.45
SD
CV
1 0.039
6.8
0.037
6.4
2
0.352
6.5
0.311
5.8
3 2.21
6.2
2.01
5.7
# Points 263 804 288 854 305 901
# Labs 15 16 15 16 16 17
Roche Elecsys / cobas e 411 Series • Roche TSH REF 11731459

Mean −− −− 5.21 5.21 34.16 34.16
SD
CV
1 −−
−−
−−
−−
2
0.213
4.1
0.213
4.1
3 0.948
2.8
0.948
2.8
# Points −− −− 17 17 17 17
# Labs 1 1 1 1

Mean 0.549 0.554 5.22 5.24 34.90 34.92
SD
CV
1 0.035
6.4
0.034
6.1
2 0.314
6.0
0.286
5.5
3 1.74
5.0
1.59
4.6
# Points 5557 18359 5079 17140 4078 14037
# Labs 196 222 182 208 175 195
TSH FIA µIU/mL

Mean 0.497 0.488 5.46 5.37 37.34 37.16
SD
CV
1 0.034
6.8
0.029
6.0
2 0.297
5.4
0.269
5.0
3 1.76
4.7
1.52
4.1
# Points 12 25 12 50 11 26
# Labs 3 3 3 4 3 3
TSH FIA µIU/mL

Mean 0.497 0.488 5.46 5.37 37.34 37.16
SD
CV
1 0.034
6.8
0.029
6.0
2 0.297
5.4
0.269
5.0
3 1.76
4.7
1.52
4.1
# Points 12 25 12 50 11 26
# Labs 3 3 3 4 3 3
Valproic Acid (Depakene) Chemiluminescence µg/mL

Mean 30.10 30.55 72.58 73.29 111.7 113.7
SD
CV
1 2.21
7.3
2.62
8.6
2 4.07
5.6
4.58
6.3
3 5.17
4.6
6.20
5.5
# Points 116 466 113 465 109 449
# Labs 8 8 7 8 8 9

Mean −− 36.35 −− 77.98 −− 117.3
SD
CV
1 −−
−−
2.31
6.4
2 −−
−−
5.48
7.0
3 −−
−−
9.47
8.1
# Points −− 51 −− 52 −− 50
# Labs 2 2 2

Mean 32.03 32.58 77.63 77.91 120.3 122.6
SD
CV
1 1.55
4.9
1.92
5.9
2 9.44
12.2
7.68
9.9
3 5.39
4.5
6.75
5.5
# Points 42 93 57 93 69 119
# Labs 4 4 4 4 5 5

Mean 38.01 38.01 80.54 80.54 118.8 118.8
SD
CV
1 2.77
7.3
2.77
7.3
2 3.89
4.8
3.89
4.8
3 6.59
5.5
6.59
5.5
# Points 12 12 12 12 12 12
# Labs 1 1 1 1 1 1

Mean 31.14 31.47 74.69 74.51 115.2 115.7
SD
CV
1 2.95
9.5
3.14
10.0
2 6.82
9.1
5.63
7.6
3 6.77
5.9
7.48
6.5
# Points 170 622 182 622 190 630
# Labs 13 15 12 15 14 17
Valproic Acid (Depakene) EIA µg/mL

Mean 36.16 35.48 79.63 79.43 121.0 118.8
SD
CV
1 1.93
5.3
2.22
6.3
2 2.55
3.2
3.20
4.0
3 5.23
4.3
5.82
4.9
# Points 107 374 76 179 108 376
# Labs 3 3 2 2 3 3
Beckman Coulter AU Series • Emit 2000 Valproic Acid, REF OSR4G229

Mean 36.39 36.39 −− −− 120.2 120.2
SD
CV
1 3.77
10.4
3.77
10.4
−−
−−
2 −−
−−
3 8.62
7.2
8.62
7.2
# Points 45 45 −− −− 48 48
# Labs 2 2 2 2

Mean 31.41 31.84 74.63 76.57 115.7 118.2
SD
CV
1 1.74
5.5
1.63
5.1
3.132
4.2
3.29
4.3
3 2.61
2.3
3.82
3.2
# Points 31 64 31 64 31 64
# Labs 1 2 1 2 1 2
Valproic Acid (Depakene) EIA µg/mL

Mean 35.16 35.24 76.91 77.19 118.5 116.9
SD
CV
1 1.93
5.5
2.16
6.1
2 4.44
5.8
4.33
5.6
3 6.03
5.1
6.54
5.6
# Points 199 1604 199 1612 193 1610
# Labs 6 8 6 8 6 8

Mean 33.35 32.85 −− 73.06 113.5 111.7
SD
CV
1 1.49
4.5
1.46
4.5
2 −−
−−
3.17
4.3
3 3.77
3.3
4.33
3.9
# Points 68 179 −− 59 68 175
# Labs 2 3 1 2 3
Roche cobas c 303/503 • Roche VALP2, REF 08058814/08445575

Mean 33.96 33.96 73.86 73.86 114.5 114.5
SD
CV
1 1.17
3.5
1.17
3.5
3.02
4.1
2 3.02
4.1
3 4.41
3.8
4.41
3.8
# Points 9 9 6 6 9 9
# Labs 1 1 1 1 1 1

Mean 36.96 35.71 74.55 75.27 113.6 114.7
SD
CV
1 2.21
6.0
2.13
6.0
2 3.57
4.8
3.62
4.8
3 4.36
3.8
4.26
3.7
# Points 39 278 35 247 38 280
# Labs 2 3 2 2 3 3

Mean 35.12 35.09 77.01 77.02 117.9 116.7
SD
CV
1 2.52
7.2
2.31
6.6
2 4.21
5.5
4.26
5.5
3 6.21
5.3
6.32
5.4
# Points 498 2553 347 2167 495 2562
# Labs 17 22 12 16 18 22
Valproic Acid (Depakene) Immunoturbidimetric µg/mL

Mean 31.31 30.65 72.16 73.03 115.7 114.2
SD
CV
1 1.12
3.6
1.96
6.4
2 3.49
4.8
2.99
4.1
3 2.88
2.5
8.65
7.6
# Points 11 19 12 20 11 25
# Labs 2 3 2 3 2 3

Mean 34675 34675 81.09 81.09 123.4 123.4
SD
CV
1 0.000
0.0
0.000
0.0
2 1.94
2.4
1.94
2.4
3 2.07
1.7
2.07
1.7
# Points 21 21 21 21 21 21
# Labs 1 1 1 1 1 1

Mean 36.87 37.14 80.02 80.12 115.1 115.7
SD
CV
1 0.962
2.6
1.21
3.3
2 1.63
2.0
2.03
2.5
3 3.13
2.7
3.26
2.8
# Points 107 634 109 614 106 585
# Labs 5 5 5 5 5 5

Mean 38.55 38.20 −− −− 107.4 108.1
SD
CV
1 2.21
5.7
1.89
5.0
2 −−
−−
−−
−−
3 3.31
3.1
3.48
3.2
# Points 39 103 −− −− 34 90
# Labs 2 2 2 2

Mean 4123 973.3 79.51 79.93 114.6 114.9
SD
CV
1 11205
271.7
5621
577.5
2 2.95
3.7
2.40
3.0
3 5.42
4.7
4.61
4.0
# Points 178 777 142 655 172 721
# Labs 10 11 8 9 10 11
Valproic Acid (Depakene) KIMS (Roche) µg/mL

Mean 33.99 33.72 76.66 74.80 114.4 114.4
SD
CV
1 1.53
4.5
1.27
3.8
2 4.50
5.9
4.55
6.1
3 5.99
5.2
6.33
5.5
# Points 7 11 7 11 7 11
# Labs 1 1 1 1 1 1

Mean 33.99 33.72 76.66 74.80 114.4 114.4
SD
CV
1 1.53
4.5
1.27
3.8
2 4.50
5.9
4.55
6.1
3 5.99
5.2
6.33
5.5
# Points 7 11 7 11 7 11
# Labs 1 1 1 1 1 1
Vancomycin Chemiluminescence µg/mL

Mean 7.58 7.32 19.81 19.72 35.75 35.19
SD
CV
1 0.411
5.4
0.596
8.1
2 0.628
3.2
0.789
4.0
3 1.69
4.7
1.38
3.9
# Points 65 429 16 157 62 420
# Labs 7 8 3 4 6 7

Mean 6.52 6.47 −− −− 30.08 30.13
SD
CV
1 0.342
5.2
0.351
5.4
2 −−
−−
−−
−−
3 1.11
3.7
1.16
3.8
# Points 62 88 −− −− 62 88
# Labs 2 2 2 2

Mean −− 6.28 −− 16.71 −− 29.98
SD
CV
1 −−
−−
0.375
6.0
2 −−
−−
0.765
4.6
3 −−
−−
1.48
4.9
# Points −− 15 −− 14 −− 15
# Labs 1 1 1

Mean 7.07 7.15 19.81 19.47 32.92 34.19
SD
CV
1 0.651
9.2
0.659
9.2
2 0.628
3.2
1.14
5.9
3 3.18
9.7
2.43
7.1
# Points 127 532 16 171 124 523
# Labs 9 11 3 5 8 10
Vancomycin EIA µg/mL

Mean 5.90 5.94 14.91 15.01 25.62 25.54
SD
CV
1 0.525
8.9
0.535
9.0
2 0.609
4.1
0.686
4.6
3 1.37
5.3
1.46
5.7
# Points 155 417 127 263 155 417
# Labs 4 6 3 4 4 6
Beckman Coulter AU Series • Emit 2000 Vancomycin, REF OSR4W229

Mean 6.09 6.01 −− −− 25.83 25.68
SD
CV
1 0.435
7.1
0.423
7.0
−−
−−
2 −−
−−
3 1.62
6.3
1.59
6.2
# Points 70 304 −− −− 73 304
# Labs 3 3 3 3

Mean 6.20 6.15 16.46 16.47 29.87 29.67
SD
CV
1 0.265
4.3
0.301
4.9
2 0.389
2.4
0.369
2.2
3 0.842
2.8
1.02
3.4
# Points 26 29 26 29 26 29
# Labs 1 1 1 1 1 1
Vancomycin EIA µg/mL

Mean 6.78 6.12 17.50 15.06 30.52 26.19
SD
CV
1 0.070
1.0
0.622
10.2
2 0.190
1.1
1.59
10.6
3 0.400
1.3
2.91
11.1
# Points 24 97 24 97 24 97
# Labs 1 1 1 1 1 1

Mean 6.24 6.56 −− −− 29.40 30.34
SD
CV
1 0.270
4.3
0.381
5.8
2 −−
−−
−−
−−
3 0.748
2.5
1.55
5.1
# Points 5 81 −− −− 5 84
# Labs 1 1 1 1

Mean 5.93 6.16 14.11 14.51 24.90 25.29
SD
CV
1 0.284
4.8
0.320
5.2
2 0.460
3.3
0.538
3.7
3 1.10
4.4
1.04
4.1
# Points 49 379 39 360 38 384
# Labs 4 5 3 4 3 4

Mean 6.04 6.08 15.24 14.83 26.35 25.95
SD
CV
1 0.491
8.1
0.474
7.8
2 1.15
7.5
0.897
6.1
3 2.18
8.3
2.02
7.8
# Points 329 1307 216 749 321 1315
# Labs 14 17 8 10 13 16
Vancomycin Immunoturbidimetric µg/mL

Mean 7.53 7.51 18.54 18.76 34.60 33.89
SD
CV
1 0.391
5.2
0.370
4.9
2 0.948
5.1
0.704
3.8
3 1.82
5.2
1.55
4.6
# Points 70 264 61 250 72 266
# Labs 7 7 6 7 7 7

Mean 6.57 6.56 17.25 17.27 30.09 30.21
SD
CV
1 0.309
4.7
0.229
3.5
2 0.515
3.0
0.419
2.4
3 1.35
4.5
0.900
3.0
# Points 152 881 142 851 140 827
# Labs 6 6 6 6 6 6

Mean 6.51 6.61 18.43 17.83 31.32 31.23
SD
CV
1 0.331
5.1
0.362
5.5
2 1.02
5.5
0.747
4.2
3 1.90
6.1
1.69
5.4
# Points 98 309 6 38 89 276
# Labs 5 6 2 3 5 6

Mean 6.42 6.59 −− −− 29.69 30.11
SD
CV
1 0.257
4.0
0.386
5.8
2 −−
−−
−−
−−
3 1.89
6.4
1.34
4.4
# Points 33 292 −− −− 33 275
# Labs 1 1 1 1

Mean 6.73 6.72 17.66 17.62 31.35 30.96
SD
CV
1 0.520
7.7
0.455
6.8
2 0.909
5.1
0.799
4.5
3 2.45
7.8
1.84
5.9
# Points 353 1746 209 1139 334 1644
# Labs 19 20 14 16 19 20
Vancomycin KIMS (Roche) µg/mL

Mean 6.23 6.13 16.92 16.82 30.13 29.70
SD
CV
1 0.603
9.7
0.634
10.3
2 0.899
5.3
0.993
5.9
3 1.28
4.3
1.45
4.9
# Points 337 1909 323 1885 338 1884
# Labs 9 11 8 10 9 11

Mean 6.09 6.12 −− 16.62 30.13 29.86
SD
CV
1 0.252
4.1
0.290
4.7
2 −−
−−
0.549
3.3
3 0.754
2.5
1.09
3.6
# Points 67 159 −− 43 66 158
# Labs 2 3 1 2 3
Roche cobas c 303/503 • Roche VANC3, REF 08445605/08058849

Mean 6.32 6.32 17.83 17.83 30.51 30.51
SD
CV
1 0.138
2.2
0.138
2.2
0.000
0.0
2 0.000
0.0
3 0.481
1.6
0.481
1.6
# Points 4 4 1 1 4 4
# Labs 1 1 1 1 1 1

Mean 6.21 6.13 16.93 16.81 30.13 29.72
SD
CV
1 0.560
9.0
0.614
10.0
2 0.899
5.3
0.985
5.9
3 1.20
4.0
1.42
4.8
# Points 408 2072 324 1929 408 2046
# Labs 12 15 9 12 12 15
Vancomycin Turbidimetric, kinetic rate µg/mL

Mean 7.68 7.75 19.63 19.80 34.47 34.60
SD
CV
1 0.191
2.5
0.212
2.7
2 0.370
1.9
0.457
2.3
3 0.495
1.4
0.522
1.5
# Points 23 31 23 31 23 31
# Labs 1 1 1 1 1 1
Method Group • Turbidimetric, kinetic rate

Mean 7.68 7.75 19.63 19.80 34.47 34.60
SD
CV
1 0.191
2.5
0.212
2.7
2 0.370
1.9
0.457
2.3
3 0.495
1.4
0.522
1.5
# Points 23 31 23 31 23 31
# Labs 1 1 1 1 1 1
Vitamin B12 Chemiluminescence pg/mL

1drop
Mean 350.3 356.8 −− −− 769.9 782.0
SD
CV
1 7.10
2.0
11.73
3.3
2 −−
−−
−−
−−
3 31.60
4.1
34.42
4.4
# Points 23 205 −− −− 24 205
# Labs 1 1 1 1
Abbott Alinity i
Mean 402.6 401.4 598.1 598.1 763.5 765.6
SD
CV
1 34.41
8.5
34.87
8.7
2 44.02
7.4
43.72
7.3
3 54.37
7.1
54.54
7.1
# Points 1441 4150 1319 3931 1334 3821
# Labs 54 60 50 56 53 58

Mean 369.3 373.7 563.3 567.1 728.7 736.4
SD
CV
1 22.75
6.2
28.38
7.6
2 31.65
5.6
34.92
6.2
3 41.18
5.7
45.12
6.1
# Points 518 1938 454 1599 543 1932
# Labs 30 37 25 31 29 33

Mean 431.0 447.0 660.4 668.5 −− −−
SD
CV
1 32.24
7.5
43.98
9.8
2 47.11
7.1
52.65
7.9
3 −−
−−
−−
−−
# Points 27 82 27 82 −− −−
# Labs 1 1 1 1

Mean 378.1 372.7 742.8 709.5 960.9 942.3
SD
CV
1 35.81
9.5
29.78
8.0
2 84.52
11.4
67.52
9.5
3 97.32
10.1
82.59
8.8
# Points 15 66 25 107 17 63
# Labs 2 2 3 4 2 3

Mean 282.9 281.5 473.5 470.3 628.8 628.5
SD
CV
1 16.09
5.7
18.34
6.5
2 27.18
5.7
31.41
6.7
3 58.39
9.3
52.10
8.3
# Points 288 1074 243 816 290 1054
# Labs 17 19 14 15 18 20
Beckman Coulter UniCel DxC Series

Mean −− 281.8 −− 458.0 −− −−
SD
CV
1 −−
−−
18.79
6.7
2 −−
−−
24.00
5.2
3 −−
−−
−−
−−
# Points −− 15 −− 16 −− −−
# Labs 1 1

Mean 260.1 257.2 439.4 436.1 605.7 630.2
SD
CV
1 20.70
8.0
23.73
9.2
2 30.83
7.0
36.27
8.3
3 45.49
7.5
101.6
16.1
# Points 855 3222 993 3500 861 3058
# Labs 36 40 41 44 39 42
DiaSorin LIAISON/XL
Mean 478.0 484.6 816.5 843.6 −− −−
SD
CV
1 54.36
11.4
47.17
9.7
2 88.70
10.9
80.39
9.5
3 −−
−−
−−
−−
# Points 27 88 27 89 −− −−
# Labs 2 2 2 2
Mindray CL Series
Mean 455.5 462.2 687.4 699.1 878.0 878.1
SD
CV
1 16.68
3.7
15.83
3.4
2 13.83
2.0
21.97
3.1
3 9.93
1.1
19.23
2.2
# Points 28 124 24 120 22 47
# Labs 2 3 2 3 1 1

Mean 463.9 460.3 697.9 689.6 −− −−
SD
CV
1 33.64
7.3
24.39
5.3
2 38.98
5.6
26.98
3.9
3 −−
−−
−−
−−
# Points 23 60 24 61 −− −−
# Labs 2 2 2 2

Mean 378.6 381.8 608.9 603.8 848.1 832.9
SD
CV
1 39.81
10.5
42.93
11.2
2 56.00
9.2
58.10
9.6
3 78.55
9.3
86.19
10.3
# Points 116 195 116 199 112 198
# Labs 7 7 7 7 8 8

Mean 469.6 456.0 727.3 697.8 −− −−
SD
CV
1 48.89
10.4
35.92
7.9
2
64.85
8.9
51.72
7.4
3 −−
−−
−−
−−
# Points 31 79 31 79 −− −−
# Labs 1 1 1 1

Mean 405.8 404.6 633.3 628.2 885.4 878.5
SD
CV
1 33.93
8.4
34.97
8.6
2 44.55
7.0
42.81
6.8
3 63.99
7.2
59.93
6.8
# Points 985 2518 1085 2632 906 2316
# Labs 41 45 41 45 41 44

Mean 412.5 402.9 635.0 618.6 886.7 863.7
SD
CV
1 37.82
9.2
37.93
9.4
2 48.26
7.6
52.69
8.5
3 66.92
7.5
67.83
7.9
# Points 470 1286 481 1216 453 1182
# Labs 14 14 13 13 14 14

Mean 378.2 377.1 573.6 568.7 747.8 742.6
SD
CV
1 22.56
6.0
22.70
6.0
2 24.45
4.3
26.74
4.7
3 27.90
3.7
30.60
4.1
# Points 150 511 128 408 101 422
# Labs 7 7 6 6 6 6

Mean 375.3 375.9 563.9 562.7 735.2 732.1
SD
CV
1 14.88
4.0
13.47
3.6
2 13.88
2.5
12.95
2.3
3 19.25
2.6
20.01
2.7
# Points 23 33 23 33 23 33
# Labs 1 1 1 1 1 1

Mean 405.7 392.5 718.3 715.4 937.8 912.1
SD
CV
1 75.41
18.6
57.88
14.7
2 86.97
12.1
76.68
10.7
3 75.05
8.0
72.58
8.0
# Points 83 184 83 184 48 142
# Labs 5 5 5 5 3 3

Mean 244.0 239.1 364.8 345.8 561.4 546.3
SD
CV
1 52.65
21.6
54.87
23.0
2 31.66
8.7
46.95
13.6
3 26.53
4.7
46.88
8.6
# Points 25 31 25 36 19 24
# Labs 2 4 2 4 1 3
Snibe MAGLUMI Series • Snibe MAGLUMI Vitamin B12 REF 130X63002M

Mean 201.3 188.0 310.4 319.8 449.1 481.3
SD
CV
1 31.84
15.8
39.12
20.8
29.67
9.6
2
33.13
10.4
3 43.35
9.7
57.98
12.0
# Points 11 21 11 25 11 24
# Labs 1 1 1 1 1 1

Mean 359.1 358.6 613.7 617.2 775.5 782.7
SD
CV
1 12.42
3.5
13.18
3.7
2 30.51
5.0
30.52
4.9
3 38.47
5.0
35.73
4.6
# Points 1107 5447 1003 4830 1005 5097
# Labs 55 67 52 64 53 62

Mean 358.6 348.5 612.8 598.9 774.9 753.8
SD
CV
1 9.74
2.7
12.21
3.5
2
24.48
4.0
23.00
3.8
3 27.74
3.6
29.48
3.9
# Points 10 22 10 22 10 22
# Labs 1 1 1 1 1 1

Mean 366.8 359.5 578.7 574.2 763.3 759.5
SD
CV
1 61.15
16.7
60.42
16.8
2 86.06
14.9
86.11
15.0
3 109.4
14.3
101.6
13.4
# Points 6215 21250 6091 19884 5769 19618
# Labs 280 319 268 305 271 300
Vitamin B12 EIA pg/mL

Mean −− 454.9 −− 685.3 −− 879.9
SD
CV
1 −−
−−
0.000
0.0
2 −−
−−
0.000
0.0
3 −−
−−
0.000
0.0
# Points −− 1 −− 1 −− 1
# Labs 1 1 1
Tosoh AIA Models

Mean 472.7 474.5 787.8 773.6 1005 1009
SD
CV
1 29.53
6.2
32.46
6.8
2 28.59
3.6
40.43
5.2
3 39.91
4.0
48.36
4.8
# Points 23 70 23 69 23 71
# Labs 1 2 1 2 1 2

Mean 472.7 474.2 787.8 772.4 1005 1007
SD
CV
1 29.53
6.2
32.31
6.8
2 28.59
3.6
41.50
5.4
3 39.91
4.0
50.35
5.0
# Points 23 71 23 70 23 72
# Labs 1 3 1 3 1 3
Vitamin B12 Electrochemiluminescence (ECL) pg/mL

Mean 429.1 434.4 638.2 642.1 814.3 817.3
SD
CV
1 27.15
6.3
31.01
7.1
2 34.51
5.4
35.98
5.6
3 38.70
4.8
40.50
5.0
# Points 632 2068 764 2861 786 2847
# Labs 36 40 37 40 40 43
Roche cobas 6000/8000/c 311 • Roche Elecsys Vitamin B12 II, REF 07028121
Mean 408.7 409.8 612.2 612.7 784.6 783.4
SD
CV
1 13.75
3.4
13.80
3.4
2
15.92
2.6
14.83
2.4
3 17.65
2.2
17.59
2.2
# Points 73 105 71 101 72 103
# Labs 2 2 2 2 2 2
Roche cobas c 303/503 • Roche Elecsys Vitamin B12 II, REF 07028121
Mean 428.1 415.1 630.9 614.2 789.5 780.0
SD
CV
1 12.13
2.8
18.51
4.5
2
15.60
2.5
19.62
3.2
3 24.28
3.1
21.76
2.8
# Points 14 34 14 34 14 34
# Labs 1 1 1 1 1 1

Mean 429.5 427.0 627.0 630.0 797.7 790.0
SD
CV
1 25.48
5.9
25.85
6.1
2 33.26
5.3
32.96
5.2
3 34.78
4.4
33.03
4.2
# Points 1012 2651 802 2131 580 1580
# Labs 36 37 32 33 23 26
Roche cobas e 402/801 • Roche Elecsys Vitamin B12 II, REF 07028121
Mean 441.6 431.2 636.0 626.7 808.5 800.0
SD
CV
1 16.92
3.8
20.53
4.8
2
19.21
3.0
23.56
3.8
3 25.52
3.2
26.49
3.3
# Points 214 484 97 292 211 479
# Labs 8 10 5 7 8 10
Mean 450.9 462.2 882.1 893.9 −− −−
SD
CV
1 41.57
9.2
34.50
7.5
2
22.04
2.5
25.50
2.9
3 −−
−−
−−
−−
# Points 31 61 31 61 −− −−
# Labs 1 1 1 1

Mean 430.5 433.6 632.8 635.5 828.6 832.1
SD
CV
1 41.32
9.6
44.12
10.2
2 49.97
7.9
49.71
7.8
3 52.78
6.4
57.01
6.9
# Points 686 2321 756 2583 644 2159
# Labs 41 45 46 49 43 49
Vitamin B12 Electrochemiluminescence (ECL) pg/mL

Roche Elecsys / cobas e 411 Series • Alternate Calibration
Mean −− −− 671.4 659.4 852.4 857.1
SD
CV
1 −−
−−
−−
−−
2
40.47
6.0
65.70
10.0
3 37.63
4.4
45.77
5.3
# Points −− −− 7 18 6 17
# Labs 1 1 1 1

Mean −− −− 592.1 592.1 −− −−
SD
CV
1 −−
−−
−−
−−
2 15.98
2.7
15.98
2.7
3 −−
−−
−−
−−
# Points −− −− 3 3 −− −−
# Labs 1 1

Mean 430.3 431.2 635.1 637.6 812.5 813.9
SD
CV
1 30.62
7.1
33.71
7.8
2 47.61
7.5
45.85
7.2
3 42.66
5.3
46.64
5.7
# Points 2662 7724 2538 8066 2307 7202
# Labs 125 136 125 134 117 131

Worldwide Report: Immunoassay Plus - Lot 40440 - Exp 28 Feb 2026

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July 2024

17−Alpha−Hydroxyprogesterone Chemiluminescence ng/mL

Snibe MAGLUMI Series

Snibe MAGLUMI Series • Snibe MAGLUMI 17−OH Prog. REF 130X98004M

YHLO iFlash 3000

Method Group • Chemiluminescence

17−Alpha−Hydroxyprogesterone EIA ng/mL

DYNEX Technologies DS2 • Diagnostics Biochem Canada

Copyright © 2017 Bio−Rad Laboratories, Inc. Generated 29−Aug−2024 17:06:28 Page 1

17−Alpha−Hydroxyprogesterone EIA ng/mL

17−Alpha−Hydroxyprogesterone RIA ng/mL

Method Group • RIA

25−Hydroxy Vitamin D, Total Chemiluminescence ng/mL

Autobio Autolumo Series Analyzers

Beckman Coulter Access, LXi 725, DxC 600i IA Systems

Copyright © 2017 Bio−Rad Laboratories, Inc. Generated 29−Aug−2024 17:06:28 Page 2

25−Hydroxy Vitamin D, Total Chemiluminescence ng/mL

Siemens ADVIA Centaur Systems

Siemens Atellica IM Analyzer

Snibe MAGLUMI Series

VITROS Microwell Series

Method Group • Chemiluminescence

25−Hydroxy Vitamin D, Total Electrochemiluminescence (ECL) ng/mL

Roche cobas 6000/8000/c 311

Copyright © 2017 Bio−Rad Laboratories, Inc. Generated 29−Aug−2024 17:06:28 Page 3

25−Hydroxy Vitamin D, Total Electrochemiluminescence (ECL) ng/mL

Method Group • Electrochemiluminescence (ECL)

25−Hydroxy Vitamin D, Total FIA ng/mL

Method Group • FIA

Acetaminophen Chemiluminescence µg/mL

Method Group • Chemiluminescence

Acetaminophen EIA µg/mL

Roche cobas 6000/8000/c 311

Copyright © 2017 Bio−Rad Laboratories, Inc. Generated 29−Aug−2024 17:06:28 Page 4

Acetaminophen EIA µg/mL

Acetaminophen Electrochemiluminescence (ECL) µg/mL

Method Group • Electrochemiluminescence (ECL)

Acetaminophen Enzymatic µg/mL

Roche cobas c 303/503

Method Group • Enzymatic

Acetaminophen Enzymatic, colorimetric µg/mL

Abbott ARCHITECT/Alinity (c, i, ci models) • Sekisui Diagnostics SEKURE

Roche cobas 6000/8000/c 311

Copyright © 2017 Bio−Rad Laboratories, Inc. Generated 29−Aug−2024 17:06:28 Page 5

Acetaminophen Enzymatic, colorimetric µg/mL

VITROS Microslide Series • Slide generation #17

Method Group • Enzymatic, colorimetric

ACTH Chemiluminescence pg/mL

Siemens IMMULITE 2000/2500/XPi

Method Group • Chemiluminescence

ACTH Electrochemiluminescence (ECL) pg/mL

Roche cobas e 402/801

Copyright © 2017 Bio−Rad Laboratories, Inc. Generated 29−Aug−2024 17:06:28 Page 6

ACTH Electrochemiluminescence (ECL) pg/mL

Snibe MAGLUMI Series

Method Group • Electrochemiluminescence (ECL)

AFP Chemiluminescence IU/mL

Abbott ARCHITECT/Alinity (c, i, ci models) • Abbott ARCHITECT AFP (3P36)

Abbott ARCHITECT/Alinity (c, i, ci models) • Abbott ARCHITECT AFP (7K67)