Evaluation of the ARKRAY HA-8190V instrument for HbA1c.

Abstract

Hemoglobin A1c (HbA1c) is a valuable parameter in the monitoring of diabetic patients and increasingly in diagnosis of diabetes. Manufacturers continuously optimize instruments, currently the main focus is to achieve faster turnaround times. It is important that performance specifications remain of high enough standard, which is evaluated in this study for the new ARKRAY HA-8190V instrument. The Clinical and Laboratory Standards Institute (CLSI) protocols EP-5, EP-9 and EP-10 were applied to investigate imprecision, bias and linearity. In addition potential interferences, performance in External Quality Assessment (EQA) and performance against the HA-8180V instrument in 220 clinical samples was evaluated. The HA-8190V demonstrates a CV of≤0.8% in IFCC SI units (≤0.6% National Glycohemoglobin Standardization Program [NGSP]) at 34 and 102mmol/mol levels (5.3 and 11.5% NGSP) and a bias of-0.1mmol/mol (-0.01% NGSP) at a concentration of 50mmol/mol (6.7% NGSP), but with a significant slope as compared to target values. This results in a bias of-1.0 and 0.9mmol/mol (-2.0 and 0.9% NGSP) at the 30 and 70mmol/mol (4.9 and 8.6% NGSP) concentration level. Simulation of participation in the IFCC certification programme results in a Silver score (bias-0.1mmol/mol, CV 1.1%). Interference in the presence of the most important Hb variants (AS, AC, AE, AD) and elevated HbA2 and HbF concentrations is less than 3mmol/mol (0.3% NGSP) at a concentration of 50mmol/mol (6.7% NGSP). Analytical performance of the HA-8190V is very good, especially with respect to precision and HbA1c quantification in the presence of the most common Hb variants.