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

Abstract

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.

Keywords:

• HbA1c; diabetes
• performance specifications
• verification
• ARKRAY ADAMS A1c Lite HA-8380V analyzer

Acknowledgments

The author wish to thank Dr Beate Saeger and Mr Ibon Untzilla for their support and assistance.

Disclosure statement

The author states no conflict of interest.