Analytical evaluation of the ADAMS™ A1c HA8180T analyzer for the measurement of HbA1c

Abstract

Background: The ADAMS™ A1c HA-8180T (ARKRAY, Inc., Kyoto, Japan) is a high pressure liquid chromatography system designed for separation and quantitation of HbA1c, while detecting hemoglobin (Hb) variants and HbA2, with an analysis time of just 3.5 min. The aim was to evaluate the analytical performance of this analyzer for routine HbA1c quantitation. Methods: Trueness, imprecision, carry over, linearity, the effect of anemia and correlation with ADAMS™ A1c HA-8180V (in Variant mode) were assessed according to guidelines of the Clinical and Laboratory Standards Institute (CLSI) and manufacturer. The presence of coexisting interfering chemically modified Hb variants was also assessed. Results: The results were found to be accurate (total error of 1.74%) and precise: within-run, between-run, between-day and total coefficients of variation were 0.71%, 0.77%, 0.36%, and 0.93% at low concentrations, and 0.43%, 0.29%, 0%, and 0.48% at high concentrations of HbA1c. Carry over, linearity, and correlation of methods were excellent. HbA1c measurement was independent of total Hb concentration in a range 40-214 g/L, and shows no interference from Hb chemically modified commonly observed in this type of analysis, while common Hb variants are detected. Conclusion: The analyzer is a suitable system for glycemic control in patients with diabetes and the detection of Hb variants.