Direct HbA1c (On-Board Lysis)

Assay Principle
Direct HbA1c Assay is an enzymatic assay in which lysed whole blood samples are subjected to extensive protease digestion with Bacillus sp protease. This process releases amino acids including glycated valines from the hemoglobin beta chains. Glycated valines then serve as substrates for specific recombinant fructosyl valine oxidase (FVO) enzyme. The recombinant FVO specifically cleaves N-terminal valines and produces hydrogen peroxide. This, in turn, is measured using a horseradish peroxidase (POD) catalyzed reaction and a suitable chromogen. No separate measurement for total Hemoglobin (Hb) is needed in this Direct HbA1c Assay. The HbA1c concentration is expressed directly as %HbA1c by use of a suitable calibration curve in which the calibrators have values for each level in %HbA1c.

Features
Direct HbA1c (Enzymatic, On-Board Lysis) is a unique single channel assay ideal for labs requiring a high throughput HbA1c method with no off-line pretreatment steps. High throughput is obtained using a patented single channel method which eliminates the need for a dedicated channel for total hemoglobin, thereby improving assay turnaround time and providing the added convenience of instrument specific packaging options. The assay has a wide AMR range of 4.0% - 12.0% HbA1c. The assay offers enhanced precision and is resistant to interference from variant hemoglobin and post transcript modifications which can impact the accuracy of other HbA1c assays.

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