Evaluation of the ARKRAY HA-8190V instrument for HbA1c
https://doi.org/10.1515/cclm-2020-1300
Received: August 25, 2020; accepted December 11, 2020;
published online December 23, 2020
Eline A.E van der Hagen
Sanne Leppink
Karin Bokkers
Carla Siebelder
Cas W. Weykamp
Abstract
HemoglobinA1c (HbA1c) is the key parameter formonitoring of glycemic control in diabetic patients. Due to increased standardization, HbA1c is used more and more as diagnostic criterion as well. In 2011, the World Health Organization concluded that HbA1c could be used as diagnostic test, but already in 2010, it was incorporated as diagnostic criterium in the American Diabetes Association Standards of Diabetes Care. Performance of instruments in terms of precision and trueness are key to reliable results. Now that this seems well established in most methods, manufacturers are focusing on similar specifications for Point-Of-Care Devises, and for the laboratory instruments on decreasing time of analysis and smaller sample volumes. HPLC ion-exchange chromatography is one of the major techniques used for HbA1c analysis. In succession of the widely used HA-8180V instrument, ARKRAY has developed the ARKRAY HA-8190V with regular (variant mode) analysis times of 58 s (vs. 90 s of the HA-8180V) and in fast mode 24 s (vs. 48 s HA-8180V). Sample volume has decreased from ∼14 to 8 μL. Other new features vs. the HA-8180V are as follows: tube spinning has been added to enable easier barcode reading, the instrument can be operated through a touch screen and automatic switching between the fast and variant mode is made possible. To evaluate whether these improvements did not affect quality of the HbA1c result, the HA-8190V was evaluated in this study.