Lyphochek® Immunoassay Plus Control

Levels 1, 2 and 3
370 Trilevel 12 x 5 mL
Level 1 40431
371 Level 1 12 x 5 mL
0459 2025-10-31 40430 Level 2 40432
372 Level 2 12 x 5 mL
Level 3 40433
373 Level 3 12 x 5 mL
370X MiniPak 3 x 5 mL

https://www.myeinserts.com/40430

Revision Date 2023-09-25 Indicates Revised Information

INSTRUMENT (1)
Level 1 - 40431 Level 2 - 40432 Level 3 - 40433
Units Mean Range Mean Range Mean Range
BECKMAN COULTER UniCel DxI
AFP ng/mL 17.7 12.9 – 22.4 97.6 71.8 – 123 208 153 – 263
CEA (CEA2) ng/mL 2.13 1.60 – 2.66 21.7 16.5 – 26.9 43.5 33.1 – 53.8
Cortisol µg/dL 2.62 1.65 – 3.59 18.3 13.9 – 22.6 28.3 21.7 – 34.8
C-Peptide (2) ng/mL 1.20 0.840 – 1.56 3.71 2.60 – 4.82 6.16 4.31 – 8.01
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) (DHEA-S) µg/dL 65.2 47.4 – 82.9 149 111 – 187 471 354 – 588
Digoxin ng/mL 0.823 0.602 – 1.04 2.17 1.75 – 2.59 3.55 2.92 – 4.17
Estradiol (Sensitive) pg/mL 96.3 49.5 – 143 242 155 – 329 385 258 – 512
Estriol (Free) (Unconjugated Estriol) ng/mL 1.37 0.934 – 1.80 4.00 3.09 – 4.90 >6.90
Ferritin ng/mL 51.6 39.8 – 63.4 159 120 – 198 375 284 – 466
Folate (FOLW) ng/mL 4.26 3.19 – 5.33 10.1 7.88 – 12.2 17.5 13.9 – 21.1
Follicle Stimulating Hormone (FSH) (hFSH) mIU/mL 9.34 7.04 – 11.6 27.2 20.7 – 33.7 47.8 36.4 – 59.3
hCG (Total ßhCG) (5th IS) mIU/mL 6.45 5.09 – 7.80 25.7 20.7 – 30.6 245 199 – 290
Insulin (Ultrasensitive Insulin) µIU/mL 14.5 11.6 – 17.4 52.2 42.1 – 62.3 158 127 – 188
Luteinizing Hormone (LH) (hLH) mIU/mL 1.23 0.864 – 1.60 15.7 12.1 – 19.2 59.5 46.3 – 72.7
Progesterone ng/mL 0.583 0.418 – 0.749 11.1 8.58 – 13.6 26.2 20.3 – 32.1
Progesterone (P4DE) ng/mL 0.345 0.239 – 0.450 8.83 6.65 – 11.0 22.7 17.1 – 28.4
Prolactin ng/mL 5.73 4.50 – 6.97 16.1 12.8 – 19.4 31.2 24.8 – 37.5
PSA (Free) (Hybritech free PSA) ng/mL 0.462 0.347 – 0.576 2.18 1.74 – 2.63 15.1 12.2 – 18.0
PSA (Free) (WHO 96/668) ng/mL 0.364 0.273 – 0.453 1.77 1.37 – 2.13 11.9 9.60 – 14.2
PSA (Total) (Hybritech PSA) ng/mL 0.831 0.651 – 1.01 3.72 2.99 – 4.46 24.3 19.6 – 28.9
PSA (Total) (WHO 96/670) ng/mL 0.702 0.550 – 0.853 2.90 2.33 – 3.47 18.9 15.3 – 22.5
T3 (Free) (Free T3) pg/mL 2.40 1.70 – 3.10 5.80 3.91 – 7.68 8.59 5.68 – 11.5
T3 (Total) (Total T3) ng/mL 0.945 0.664 – 1.23 2.21 1.72 – 2.70 3.57 2.89 – 4.25
T3 Uptake/T Uptake % Uptake 43.9 35.9 – 51.9 50.2 41.3 – 59.1 53.3 44.0 – 62.6
T4 (Free) (Free T4) ng/dL 0.897 0.681 – 1.11 2.70 2.14 – 3.26 4.04 3.21 – 4.87
T4 (Total) (Total T4) µg/dL 6.25 4.43 – 8.07 10.9 8.19 – 13.5 14.5 11.2 – 17.9
Testosterone ng/mL 1.18 0.919 – 1.45 3.52 2.74 – 4.29 7.40 5.77 – 9.02
Thyroid Stimulating Hormone (TSH) (3rd IS) µIU/mL 0.425 0.360 – 0.489 5.67 4.31 – 7.03 31.9 24.0 – 39.8
Thyroid Stimulating Hormone (TSH) (hTSH, HYPERsensitive) µIU/mL 0.452 0.385 – 0.518 6.35 4.82 – 7.87 35.0 26.3 – 43.6
Vitamin B12 pg/mL 243 173 – 313 440 324 – 556 648 483 – 813
ROCHE ELECSYS / E170 / COBAS e SYSTEMS
ACTH pg/mL 24.4 8.25 – 40.5 79.6 38.6 – 121 156 80.1 – 231
AFP ng/mL 17.0 12.8 – 21.2 101 78.5 – 123 217 169 – 264
Calcitonin pg/mL 37.5 21.1 – 53.9 202 148 – 255 429 323 – 536
CEA ng/mL 2.39 1.84 – 2.94 17.7 14.6 – 20.7 33.7 28.0 – 39.5
Cortisol (II) µg/dL 2.98 2.28 – 3.68 17.3 13.9 – 20.8 26.3 21.2 – 31.4
C-Peptide ng/mL 1.73 1.35 – 2.11 5.28 4.32 – 6.24 8.08 6.67 – 9.49
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) (DHEA-Sulfate) µg/dL 99.1 75.6 – 123 217 171 – 263 776 621 – 931
Digoxin ng/mL 0.731 0.548 – 0.913 2.05 1.70 – 2.40 3.51 2.97 – 4.05

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 Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

INSTRUMENT (1)
Level 1 - 40431 Level 2 - 40432 Level 3 - 40433
Units Mean Range Mean Range Mean Range
ROCHE ELECSYS / E170 / COBAS e SYSTEMS (continued)
Estradiol (III) pg/mL 91.1 68.6 – 114 228 191 – 265 395 340 – 449
Ferritin ng/mL 80.0 64.9 – 95.1 204 165 – 244 437 351 – 523
Folate (cobas e801/e402) ng/mL 3.25 <2.00 – 4.50 7.65 5.56 – 9.74 14.5 11.1 – 17.8
Folate (III) (E170/e601/e602/e411) restand. ng/mL 3.01 <2.00 – 4.23 6.87 4.91 – 8.83 12.3 9.29 – 15.3
Follicle Stimulating Hormone (FSH) mIU/mL 7.47 6.16 – 8.78 20.2 16.7 – 23.8 38.7 31.9 – 45.5
hCG (+ ß) mIU/mL 4.92 3.77 – 6.06 20.1 16.4 – 23.8 223 185 – 260
hCG (STAT) mIU/mL 4.44 3.37 – 5.50 19.3 15.8 – 22.9 203 169 – 238
Human Growth Hormone (hGH) ng/mL 3.35 1.87 – 4.84 8.81 7.04 – 10.6 15.7 13.4 – 18.1
Immunoglobulin E (IgE) ng/mL 834 670 – 998 250 156 – 345 282 184 – 379
Insulin µIU/mL 16.8 13.7 – 19.8 63.1 53.1 – 73.1 188 160 – 217
Luteinizing Hormone (LH) mIU/mL 2.10 1.66 – 2.55 20.3 17.3 – 23.4 67.0 57.2 – 76.9
Progesterone (III) ng/mL 0.647 0.343 – 0.951 11.7 9.69 – 13.7 27.6 23.1 – 32.0
Prolactin ng/mL 8.77 7.33 – 10.2 24.0 20.1 – 27.9 51.2 42.9 – 59.5
Prostate Specific Antigen, Free (fPSA) (Cobas e411/e601/602) ng/mL 0.335 0.275 – 0.394 1.67 1.42 – 1.92 10.9 9.34 – 12.5
Prostate Specific Antigen, Free (fPSA) (Cobas e801/e402) ng/mL 0.329 0.274 – 0.385 1.64 1.38 – 1.90 10.5 8.84 – 12.2
Prostate Specific Antigen, Total (e411/e601/602) (tPSA) ng/mL 0.691 0.568 – 0.814 3.26 2.74 – 3.77 20.4 17.2 – 23.6
Prostate specific Antigen, Total (tPSA) (Cobas e801/e402) ng/mL 0.671 0.547 – 0.794 3.14 2.63 – 3.64 19.5 16.5 – 22.6
T3 Total ng/mL 1.04 0.787 – 1.29 2.46 1.94 – 2.98 3.66 2.91 – 4.41
T3 Uptake/T-Uptake TBI 0.966 0.836 – 1.10 0.591 0.419 – 0.763 0.338 <0.200 – 0.538
T3 (Free) (III) pg/mL 3.16 2.60 – 3.73 9.79 8.42 – 11.2 16.8 14.7 – 18.8
T4 Total µg/dL 5.98 4.70 – 7.26 10.4 8.22 – 12.5 13.2 10.4 – 15.9
T4 (Free) (II) ng/dL 1.14 1.01 – 1.27 2.99 2.44 – 3.53 4.92 3.94 – 5.90
T4 (Free) (III) ng/dL 1.22 1.07 – 1.37 3.25 2.65 – 3.85 5.50 4.40 – 6.59
Testosterone (II) ng/mL 1.55 1.15 – 1.95 4.17 3.35 – 4.99 8.79 7.23 – 10.4
Thyroid Stimulating Hormone (TSH) µIU/mL 0.517 0.352 – 0.683 6.36 5.02 – 7.71 36.7 29.2 – 44.1
Vitamin B12 (II) (E170/e601/e602/e411) pg/mL 413 324 – 502 624 512 – 737 869 729 – 1008
Vitamin B12 (II) (cobas e801/e402) pg/mL 382 296 – 467 607 496 – 717 824 689 – 959

FOOTNOTES
(1) All footnotes may not apply to your custom selected data chart.
(2) The assigned values were determined using the reagent and/or instrument manufacturer’s protocol and may not represent ±3SD ranges.
(3) For the conversion factor, refer to the manufacturer’s instruction for use.
Data is not available at this time. Please inquire.
§ The data required to establish the means and acceptable ranges for this assay were not obtained due to limited assignment participation. If your facility is
interested in participating in the Value Assignment Program for this assay, please contact your local Bio-Rad office.
Data not applicable or not available.

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