User verification of Abbott Alinity HQ hematology analyzer

Abstract Objectives This study aims to evaluate the performance characteristics of the Alinity HQ hematology analyzer in a routine laboratory setting. Methods In the study, precision (short-term and long-term precision), accuracy (method comparison with Abbott Cell Dyn Ruby and estimation of bias), confirmation of a background (Limit of Blank, LoB), and carry-over were used to evaluate the performance of Alinity HQ as recommended by ICSH, CLSI guidelines EP15-A3, EP09, EP17A2, and H26-A2. Acceptance criteria were based on manufacturer technical specifications and the EFLM Biological Variation Database. Results According to the short-term precision results, except for mean corpuscular volume (MCV) and mean corpuscular hemoglobin concentration (MCHC), all measurements exhibited coefficient variations (CV) lower than their verification limits. Basophil, eosinophil, and monocyte counts, as well as mean corpuscular hemoglobin (MCH), MCHC, and red cell distribution width standard deviation (RDW-SD), did not meet the allowable imprecision criteria for the long-term precision study. The estimated bias for all analytes was within verification limits. However, the method comparison study showed concentration-dependent variations for MCHC, MCH, and mean platelet volume (MPV) parameters. Furthermore, the correlation of parameters between Alinity HQ and Cell Dyn Ruby ranged from 0.46 to 1.00. The LoB and carry-over studies demonstrated satisfactory performance for the Alinity HQ analyzer. Conclusions Although some parameters had higher CVs than expected and concentration-dependent bias, the overall analytical performance of Alinity HQ was found to be satisfactory. Alinity HQ is an accurate, highly precise analyzer with good analytical performance, suitable for high-volume laboratories.