Analytical evaluation and quality assessment of the ARKRAY ADAMS A1c Lite HA-8380V for HbA1c

Introduction: ARKRAY ADAMS A1c Lite HA-8380V is a fully automated high- performance liquid chromatography system for the measurement of HbA1c. We aimed to evaluate its analytical performance using the Variant Mode. Methods: Carry-over, linearity, imprecision, trueness, interferences and comparison against ARKRAY ADAMS A1c HA-8180V and HA-8180T analyzers were studied. Results: Total CVs 0.93% (IFCC units), 0.63% (NGSP units) at low concentration and 1.01% (IFCC) 0.74% (NGSP), at high concentration. Mean difference with the target values was -0.44 mmol/mol (IFCC) -0.04% (NGSP). Carry-over, linearity and method comparison were excellent. The results were not affected in the range of total Hb 39-199 g/L, labile fraction 5.7%, carbamylated Hb 9.1% nor acetylated Hb 7.8%, effect of common variants was negligible. Conclusions: the analyzer demonstrated very good analytical performances, according to the consensus criteria established for HbA1c; it is adequate for laboratories with medium-low workloads.