Evaluation of an Ion-Exchange HPLC Device for HbA1c Measurement

Abstract

Background: The ADAMS™ HA-8180V is the 8th generation of a fully automated ion-exchange HPLC system from ARKRAY, and the first to be released onto the US market. We evaluated the HA-8180V, for routine hemoglobin A1c measurement in comparison with the Roche Cobas c501, the Tosoh G8 analyzer for normal hemoglobin, and with the Trinity analyzer for hemoglobin variants.

Methods: The analytical performance (linearity, precision, carryover, and sample stability) was assessed based on the Clinical and Laboratory Standards Institute (CLSI) and manufacturer guidelines. A comparison of the HA-8180V against two major analytical methods was performed for 100 whole blood samples. HA-8180V variant mode was also compared against the Trinity ultra2 A1c analyzer for 50 samples containing hemoglobin variants (HbC 14, HbS 14, HbD 12, and HbE 10).

Results: The within-run and total CVs were <0.01 and 0.75% at low HbA1c concentration and 0.46 and 0.63% at high HbA1c concentration, respectively. Linearity was shown in the concentration range 3.4-18.1% HbA1c, carryover was 0.00%, and stability values were excellent. Method comparison demonstrated a high concordance between methods.

Conclusion: The eighth generation ADAMS HA-8180V A1c analyzer demonstrated high analytical performance adequate for routine clinical use.

Keywords: HA-8180V; Hb variants; HbA1c; diabetes; evaluation.