Performance evaluation of ARKRAY HA-8190V system for measuring glycated hemoglobin
https://doi.org/10.1515/cclm-2020-1300
Received: September 21, 2021; accepted October 7, 2021;
published online October 26, 2021
Renata Paleari
Ferruccio Ceriotti
Andrea Mosca
Abstract
Introduction: the new fully automated HPLC ion-exchange system ADAMS A1c HA-8190V analyzer, developed by ARKRAY Inc., running in two different modes (Variant and Fast) has been evaluated.
Methods: reproducibility was evaluated according to the EP-15A3 standard. Method comparison was performed on 122 fresh blood samples, according to the EP-9 standard. The system was compared to 3 other HPLC analyzers, based on ion-exchange (Tosoh G11 and Bio-Rad D-100) and boronate affinity chromatography (Trinity Biotech Premier Hb9210). Usability was evaluated by using a score evaluation system.
Results: reproducibility proved to be very good at normal and high HbA1c concentration, with total CVs always <0.7 %, when HbA1c was expressed in mmol/mol as well as in % units. The HA-8190V system was well correlated to the other HPLC analyzers, with a mean bias not clinically relevant. Finally, the usability of the system was evaluated and proved to be well acceptable.
Conclusions: the ARKRAY HA-8190 V system was found to be a reliable and suitable method for routine HbA1c measurement in clinical chemistry laboratories.