Abstract

Background: We report an evaluation of the Menarini/ARKRAY ADAMS A1c HA-8180V analyser (HA-8180V), the fifth generation Menarini/ARKRAY ion-exchange HPLC for the measurement of HbA_1c.

Methods: We evaluated the analytical performance, the measurement of haemoglobin variants and the performance in comparison to major analytical methods.

Results: Within-run, between-run and total CV were 0.2%, 0.4% and 0.7% at low HbA_1c concentrations and 0.2%, 0.2% and 0.4% at high HbA_1c concentrations, respectively. Trueness revealed a maximum deviation of 0.8 mmol/mol (IFCC units) or 0.1% (NGSP units) over the relevant analytical range. Linearity, carry-over and linear drift were excellent. Labile-HbA_1c, carbamylated haemoglobin, icteric samples and variation in hematocrit did not affect HbA_1c outcome. Haemoglobin variants AS, AC and F do not affect HbA_1c outcome and are explicitly identified and correctly quantified. HbA_1c can not be measured in samples with AE and AD, but these variants are identified correctly. In comparison to other methods used at present, the HA-8180V shows excellent performance.

Conclusions: The HA-8180V performs at a high level and is fit for any clinical application.