Glycated haemoglobin (HbA1c) is a haemoglobin molecule with glucose molecule covalently bound. Determinations of HbA1c level in venous blood is used to evaluate retrospectively glucose levels. The reagent is intended to use as an aid to diagnosis of diabetes and to predict the diabetes progression. It is also used to monitor the diabetes and its treatment and to monitor the diabetes progression in prediabetes patients.
based on latex agglutination, standardized to the DCCT/NGSP reference method
Specimen
whole blood
On board stability
up to 12 weeks
Calibration stability
up to 12 weeks
Analytical measurement range
2-16%
Regulatory status
CE IVD
Storage temperature (1)
2-8°C
(1) For proper storage, follow the recommended temperature range available on the label. Full details are provided in the Instructions for Use/User Manual. Transport and store at a controlled temperature in accordance with the product labeling. Deviations from the required conditions may affect the quality of the reagent.
Reagent lines
Multipurpose Line Cormay HbA1c DIRECT HEMOLYSING REAGENT OS-HbA1c DIRECT HC-HbA1c DIRECT
ACCENT-200
ACCENT-300
A-400
A-800
Prestige 24i Prestige 24i HbA1c DIRECT (24 positions reagent tray) Prestige 24i HbA1c DIRECT (36 positions reagent tray)
The specification was based on data determined on selected analyzers. We recommend that all users should refer to the instruction for use (IFU) and instruments’ user or service manuals before proceeding.
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