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K-ASSAY
Since 1983
K-Assay
 
Clinical Diagnostics
Immunoassay Calibrators
 
Hemoglobin A1c Calibrator
HbA1c Calibrator
Cat. No.: KAI-098C
Type.: Calibrator


KIT COMPOSITION
Calibrator 1-4 Lyophilized Hemolysate 4 x 0.5 mL
    
KAI-098C
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Click here for an example package insert.

Click here for the Safety Data Sheet (SDS).


INTENDED USE
This product is for the purpose of calibrating results in the quantitative determination of human hemoglobin A1c (HbA1c) in blood by automated immunoassay.
FOR IN VITRO DIAGNOSTIC USE.

CALIBRATOR PREPARATION
Reconstitute each calibrator vial using 0.5 mL of deionized water.  Gently mix for 10 minutes, or until all material has dissolved.

STORAGE AND HANDLING
1.   Store at 2-8°C.  Stable until expiration date if sealed tightly.  PROTECT FROM LIGHT AND HEAT.

2.   The reconstituted calibrator should be stored refrigerated (2-8°C) and sealed tightly.  The calibrator retains its assigned value for at least 30 days at 2-8°C.

CALIBRATOR VALUES
The following values are given as an example.  The expected values for the K-ASSAY ®   Hemoglobin A1c Calibrator are continually being revised through ongoing quality assurance.   As a result, the expected values may change from lot to lot.  Please refer to the package insert for each lot for the exact calibrator values.

Instrument %
NGSP Units (RECOMMENDED)
mmol / mol Hb
IFCC Units
Cal 1 Cal 2 Cal 3 Cal 4 Cal 1 Cal 2 Cal 3 Cal 4
Beckman CX
(Manual Lyse)
5.1 % 8.2 % 11.9 % 15.3 % 32 66 107 144
Cobas Mira
(Manual Lyse)
4.6 % 7.8 % 11.3 % 14.9 % 27 62 100 139
Hitachi 717
(Manual Lyse)
5.1 % 8.5 % 12.3 % 15.8 % 32 69 111 149
Hitachi 917
(On-board Lyse)
4.5 % 8.0 % 12.1 % 15.1 % 26 64 109 142
Mindray BS-200
(Manual Lyse)
5.6 % 8.6 % 12.4 % 15.1 % 38 70 112 142
Olympus
(On-board Lyse)
5.1 % 8.4 % 12.0 % 15.1 % 32 68 108 142

Note: Use isotonic saline (not included) for Calibrator 0. (0.0 % or 0 mmol/mol Hb)