Direct HbA1c AssayDiazyme Laboratories recently announced that they received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Direct HbA1c assay (Enzymatic, On-Board Lysis). This new enzymatic Direct HbA1c assay is the most convenient and accurate HbA1c assay method available for use on general clinical chemistry analyzers.

Measurement of hemoglobin A1c is a valuable indicator for long-term diabetic control. It allows clinicians to track patients with diabetes. The American Diabetes Association (ADA) and other diabetes organizations worldwide recommend Hemoglobin A1c (HbA1c) as an important test for the management of patients with diabetes mellitus.

The simple and accurate Diazyme assay is highly recommended for use in all clinical laboratories. This NGSP certified assay method uses a single channel test and reports %HbA1c values directly, without the need for a separate total hemoglobin (THb) test or a calculation step. The Direct Enzymatic HbA1c Assay™ offers several advantages over HPLC and immunoassays:

  • Two reagents, liquid stable
  • No need for total hemoglobin measurement
  • Single channel on analyzers
  • Faster, simpler, and more cost effective
  • No interferences from hemoglobin variants
  • On-board blood lysis possible
  • Applicable to most analyzers
  • Excellent correlation with HPLC and immunoassays

After addition of Reagent R1, sample, and Reagent R2, the result of %HbA1c is reported within 3 minutes. These Direct Enzymatic Hemoglobin A1c reagents are intended for use in the quantitative determination of stable HbA1c in human whole blood samples. As the reagents do not contain latex particles, they do not coat analyzer cuvettes and lines.

This HbA1c assay can be used on most automated chemistry analyzers and reagent transfer can be eliminated for most chemistry systems with instrument specific packaging options including RocheTM Hitachi 917 series, Beckman AU (400/600/640/680), Beckman Synchron CX, LX and DXC analyzers.

Dr. Chong Yuan, Managing Director of Diazyme Laboratories, says, “Diazyme is excited to have developed a two liquid stable reagent enzymatic HbA1c assay with on-board lysis availability. By removing the extra steps of having to lyse the whole blood sample offline and having to measure the total hemoglobin separately, Diazyme is making HbA1c testing much simpler, more user friendly and more readily available to clinical labs of all sizes. Furthermore, Diazyme’s new HbA1c assay dramatically improves laboratory workflow.”