Diazyme Direct Enzymatic HbA1c Test Kit

Diazyme Direct Enzymatic HbA1c Test Kit

Direct Enzymatic HbA1c test Kit (liquid stable), Lysis Buffer: 1 x 30 ml R1a: 1 x 16.8 ml R1b: 1 x 7.2 ml R2: 1 x 10 ml

Diazyme’s NGSP and IFCC Certified Direct Enzymatic HbA1c assay has no interference from hemoglobin variants including HbC, HbS, HbE, and caramylated acetylated Hb or labile HbA1c. This unique freedom from interference combined with unparalleled precision (intra and inter % CV values less than 5%) means that Diazyme’s Direct Enzymatic HbA1c assay provides unique performance advantages over conventional immunoassay and chromatography methods. Diazyme’s patented enzymatic method measures HbA1c directly using only a single instrument channel and completely eliminates the latex particles cuvette contamination often seen in HbA1c immunoassay methods. This reduces instrument maintenance requirements. Diazyme’s Direct HbA1c can be used on most automated chemistry analyzers and reagent transfer can be eliminated for most chemistry systems with instrument specific packaging options including Roche Hitachi 917 series, Olympus AU (400/600/640/680). The assay correlates well with conventional methods such as the Tosoh HPLC and Roche Tina-Quant methods and has linear range of 4% - 12%. The assay is stable for 15 months from date of manufacture when stored @ 2°- 8°C.

Intended Use

Diazyme Direct Enzymatic Hemoglobin A1c (glycated hemoglobin A1c; A1c; HbA1c) reagents are intended for use in the quantitative determination of stable HbA1c in human whole blood samples. Measurement of hemoglobin A1c is a valuable indicator for long term diabetic control. For in vitro diagnostics use only.