Diabetes Control
Diabetes Control
Diabetes Control
Levels 1 and 2
Level 1 85821
740 Bilevel 6 x 0.5 mL 2023-04-30 85820 Level 2 85822
740X MiniPak 2 x 0.5 mL
http://www.myeinserts.com/85820
NOTAS
❑ No se garantiza el valor previsto ni la estabilidad de este analito.
❍ No se proporcionan valores.
LEXICÓN
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Irvine, California 92618 Denmark, Bio-Rad Laboratories, Symbion Science Park, Fruebjergvej 3, DK-2100 Copenhagen East • Phone +45 44 52 10 00 • Fax +45 44 52 10 01
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(800) 854-6737
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© 2020 Bio-Rad Laboratories Inc. Printed in the USA Página 2 ESPAÑOL/Spanish • 2020-09 • 4037-00
Lyphochek® Diabetes Control, Levels 1 and 2
MÉTODO (1)
Nivel 1 - 85821 Nivel 2 - 85822
Unidades (2) Media Rango Media Rango
HEMOGLOBINA A1C
Abbott ARCHITECT cSystems (4P52 Enzymatic) % 4.88 4.29 – 5.47 9.63 8.86 – 10.4
ARKRAY ADAMS A1C HA-8160 (Ver.
4.xx)/HA-8170/HA-8180/HA-8180T/HA-8181/HYBRID
AH-8280/AH-8290/Lite HA-8380/HA-8380V (3) % 5.00 4.50 – 5.50 9.50 8.60 – 10.4
ARKRAY ADAMS A1C HA-8180V (3) % 5.10 4.60 – 5.60 9.50 8.60 – 10.4
Beckman Coulter AU Systems (REF B00389) % § §
Beckman Coulter UniCel DxC Series % 5.27 4.73 – 5.80 9.97 9.00 – 10.9
Bio-Rad D-10 A1c Dual Program 220-0201 (3) (4) % 5.20 4.60 – 5.80 9.90 8.70 – 11.1
Bio-Rad D-10 Dual A2/F/A1c Program 220-0201 (3) (4) % 5.30 4.70 – 5.90 10.0 8.80 – 11.2
Bio-Rad D-10 Hemoglobin A1c 220-0101 / 12000949 (3) (4) % 5.20 4.60 – 5.80 9.90 8.70 – 11.1
Bio-Rad D-100 HbA1c (3) (4) % 5.20 4.60 – 5.80 9.90 8.70 – 11.1
Bio-Rad VARIANT II Dual Kit Beta-Thal 270-2500 (3) (5) % 5.00 4.40 – 5.60 10.1 8.90 – 11.3
Bio-Rad VARIANT II HbA1c Dual Program 270-2500 (3) (5) % 5.30 4.70 – 5.90 10.2 9.00 – 11.4
Bio-Rad VARIANT II Hemoglobin A1c Program 270-2101NU (3)
(4) % 5.30 4.70 – 5.90 10.0 8.80 – 11.2
Bio-Rad VARIANT II TURBO HbA1c Kit 2.0 270-2455 /
12000447 (3) (4) % 5.20 4.60 – 5.80 10.2 9.00 – 11.4
Bio-Rad VARIANT II TURBO HbA1c Kit 2.0 270-2455EX (3) (4) % 5.20 4.60 – 5.80 10.2 9.00 – 11.4
Boditech AFIAS Series (3) % 5.12 4.37 – 5.87 8.89 7.60 – 10.2
Boditech iCHROMA Series (3) % 5.32 4.57 – 6.07 8.94 7.65 – 10.2
Diazyme Direct Enzymatic HbA1c DZ168C (Rochi Hitachi
Systems, International / Modular) (3) % 6.00 4.80 – 7.20 9.80 7.80 – 11.8
HemoCue HbA1c 501 (3) % 5.00 4.01 – 6.00 9.40 7.53 – 11.3
Infopia / Osang Healthcare Clover A1c (3) % 5.00 4.01 – 6.00 9.30 7.45 – 11.2
Infopia / Osang Healthcare Clover A1c Plus (3) % 5.20 4.17 – 6.23 9.50 7.61 – 11.4
Infopia / Osang Healthcare Clover A1c Self (3) % 5.10 4.09 – 6.11 9.40 7.53 – 11.3
JEOL BM Test HbA1c (3) % 4.83 3.86 – 5.80 9.41 7.53 – 11.3
Ortho VITROS Microtip Series (HBA1C REF 6842905) % 5.07 4.49 – 5.64 9.85 8.66 – 11.0
Pointe Scientific Inc. Hemoglobin A1c H7546 (Beckman Coulter
AU Systems) (3) % § §
PTS Diagnostics A1CNOW+ (3) %
Roche cobas c System (Tina-quant hbA1c Gen2/Gen3) % 5.10 4.56 – 5.64 10.0 9.13 – 10.9
Roche cobas INTEGRA (Tina-quant Hemoglobin A1c) % 5.24 4.70 – 5.78 9.81 9.03 – 10.6
SAKAE A1c Gear (3) %
SAKAE A1c iGEAR (3) %
SAKAE A1c iGEAR QUICK (3) %
Samsung LABGEO PT10 (3) % § §
SEBIA CAPI 3 Hb A1c (Cat. 2515) / CAPI 3 INSTRUMENT (3) % 4.80 4.20 – 5.40 9.90 8.90 – 10.9
SEBIA CAPILLARYS hb A1c (Cat. 2015) / CAPPILARYS 2 FLEX
PIERCING INSTRUMENT (3) % 4.80 4.20 – 5.40 9.90 8.90 – 10.9
SEBIA MINICAP Hb A1c (Cat. 2215) / MINICAP FLEX PIERCING
INSTRUMENT (3) % 4.90 4.30 – 5.50 9.90 8.90 – 10.9
SEKISUI NORUDIA N hbA1c (3) % 4.97 3.98 – 5.96 9.39 7.51 – 11.3
Siemens ADVIA Chemistry Systems (Enzymatic Hemoglobin
A1c, A1c_E / A1c_EM) % 4.73 3.93 – 5.53 9.67 8.42 – 10.9
Siemens Atellica Solution Enzymatic Hemoglobin A1c (A1c_E /
A1c_H) % 4.82 4.18 – 5.46 9.59 8.20 – 11.0
Siemens DCA Series % 5.40 4.89 – 5.91 10.4 9.43 – 11.3
Siemens Dimension Series (A1C REF DF105B) (3) % 5.10 4.48 – 5.72 9.70 8.70 – 10.7
Siemens Dimension Series (HB1C REF DF105A) % 5.30 4.59 – 6.00 9.53 8.40 – 10.7
Siemens Dimension Vista Systems A1C REF K3105B (3) % 5.00 4.60 – 5.40 9.20 8.50 – 9.80
Siemens Dimension Vista Systems HbA1C REF K3105A % 5.32 4.70 – 5.93 9.58 8.58 – 10.6
8
Lyphochek® Diabetes Control, Levels 1 and 2
MÉTODO (1)
Nivel 1 - 85821 Nivel 2 - 85822
Unidades (2) Media Rango Media Rango
HEMOGLOBINA A1C (continuación)
TOSOH G11 Automated HPLC Analyzer (3) % 5.10 4.60 – 5.60 9.80 8.80 – 10.8
TOSOH G7 Automated HPLC Analyzer (3) % 5.20 4.70 – 5.70 9.90 8.90 – 10.9
Tosoh G8 Automated HPLC Analyzer (3) % 5.20 4.60 – 5.70 9.90 8.90 – 10.8
TOSOH GX Automated HPLC Analyzer (3) % 5.20 4.70 – 5.70 10.0 9.00 – 11.0
TOSOH HLC-723 G8,G9,G11 (3) % 5.21 4.69 – 5.73 9.78 8.81 – 10.8
Trinity Biotech Affinity HPLC (3) % 4.92 4.65 – 5.23 9.43 8.82 – 10.0
Trinity Biotech Premier Hb9210 (3) % 4.82 4.53 – 5.12 9.50 8.94 – 10.1
Wondfo Biotech Finecare - FIA meter (3) % 5.34 4.27 – 6.41 9.79 7.83 – 11.8
8
Lyphochek® Diabetes Control, Levels 1 and 2
INSTRUMENTO (1)
Nivel 1 - 85821 Nivel 2 - 85822
Unidades (2) Media Rango Media Rango
Beckman Coulter AU Systems
Hemoglobin A1C (REF B00389) % § §
Hemoglobin A1C (REF B00389) (Mass/Volume) g/dL § §
Hemoglobin, Total (REF B00389) g/dL § §
Beckman Coulter UniCel DxC Series
Hemoglobin A1C % 5.27 4.73 – 5.80 9.97 8.99 – 10.9
Hemoglobin A1C (Mass/Volume) g/dL 0.482 0.340 – 0.624 0.925 0.655 – 1.19
Hemoglobin, Total g/dL 14.3 10.4 – 18.2 10.8 8.00 – 13.6
Ortho VITROS MicroTip Series
Hemoglobin A1C (HBA1C REF 6842905) % 5.07 4.49 – 5.64 9.85 8.66 – 11.0
Hemoglobin A1C (HBA1C REF 6842905) (Mass/Volume) g/dL 0.425 0.302 – 0.548 0.898 0.648 – 1.15
Hemoglobin, Total (HBA1C REF 6842905) g/dL 13.3 6.09 – 20.5 10.7 3.87 – 17.5
Roche cobas c Systems
Hemoglobin A1C (Tina-quant hbA1c Gen2/Gen3) % 5.10 4.56 – 5.64 10.0 9.13 – 10.9
Hemoglobin A1C (Tina-quant hbA1c Gen2/Gen3) (Mass/Volume) g/dL 0.367 0.242 – 0.491 0.786 0.563 – 1.01
Hemoglobin, Total (Tina-quant hbA1c Gen2/Gen3) g/dL 15.2 11.2 – 19.2 12.0 8.47 – 15.5
Roche cobas INTEGRA
Hemoglobin A1C (Tina-quant Hemoglobin A1c) % 5.24 4.70 – 5.78 9.81 9.03 – 10.6
Hemoglobin A1C (Tina-quant Hemoglobin A1c) (Mass/Volume) g/dL 0.500 0.355 – 0.646 1.03 0.755 – 1.30
Hemoglobin, Total (Tina-quant Hemoglobin A1c) g/dL 15.2 11.3 – 19.1 12.2 8.92 – 15.5
Siemens ADVIA Chemistry Systems
Hemoglobin A1C (Enzymatic Hemoglobin A1c, A1c_E / A1c_EM) % 4.73 3.93 – 5.53 9.67 8.42 – 10.9
Hemoglobin A1C (Enzymatic Hemoglobin A1c, A1c_E /
A1c_EM) (Molarity/Volume) µmol/L 4.29 2.04 – 6.53 9.91 4.74 – 15.1
Hemoglobin, Total (tHb_E / tHb_EM) g/dL 14.1 11.7 – 16.6 11.2 8.20 – 14.2
8
Lyphochek® Diabetes Control, Levels 1 and 2