This recently FDA cleared assay quantitatively measures percent hemoglobin A1C (HA1C) in whole blood on this companys line of Dimension integrated chemistry systems including the RxL, XL, ARx and Xpand models.
Percent HA1C is used in the long-term monitoring of blood glucose for diabetes patients. The automated assay requires no manual pretreatment and offers precise results faster within 10 minutes than ion exchange or HPLC methods.
This assay is not affected by patient samples with many common hemoglobinopathies or anemias.
The assay measures hemoglobin and hemoglobin A1C in a two cuvette method contained in a prepackaged Flex cartridge, and calculates a percent HA1C value. No hydration is required. The assay is performed using a whole-blood sample between 300-500µL. On-board assay calibration stability is 30 days with two levels of quality control needed every 24 hours. Each assay kit contains six Flex cartridges and a set of calibrators.
Keyword: assay, hemoglobin, HA1c