Intended Use
The AyoTes HPLC HbA1c Calibrator Kit is designed to calibrate glycosylated hemoglobin (HbA1c) measurement systems used with AyoTes fully automated HbA1c analyzers. It ensures accurate and standardized detection of HbA1c levels, expressed as a percentage (%) and in mmol/mol, for clinical assessment of long-term glucose control in patients of all ages. The kit contains two concentration levels (Level 1 – low, Level 2 – high) of lyophilized glycosylated hemoglobin, which must be reconstituted before use. The assigned values of the calibrators are traceable to the IFCC reference method and standardized to the DCCT level, ensuring consistency with international diabetes diagnostic standards.
