Affiliation:
1. Department of Medical Biochemistry , Başkent University Faculty of Medicine , Ankara , Türkiye
Abstract
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.
Subject
Biochemistry (medical),Clinical Biochemistry,Molecular Biology,Biochemistry
Reference20 articles.
1. Bruegel, M, George, TI, Feng, B, Allen, TR, Bracco, D, Zahniser, DJ, et al.. Multicenter evaluation of the cobas m 511 integrated hematology analyzer. Int J Lab Hematol 2018;40:672–82. https://doi.org/10.1111/ijlh.12903.
2. Woo, KS, Jeong, IH, An, GD, Lim, HH, Han, JY. Performance evaluation of new Abbott Alinity HQ hematology analyzer. Int J Lab Hematol 2019;41:657–63. https://doi.org/10.1111/ijlh.13082.
3. Clinical Laboratory Standards Institute. H20-A2: reference Leukocyte (WBC) differential count (proportional) and evaluation of instrumental methods, 2nd ed. Wayne, PA: Clinical Laboratory Standards Institute; 2007.
4. Briggs, C, Culp, N, Davis, B, d’Onofrio, G, Zini, G, Machin, SJ. ICSH guidelines for the evaluation of blood cell analysers including those used for differential leucocyte and reticulocyte counting. Int J Lab Hematol 2014;36:613–27. https://doi.org/10.1111/ijlh.12201.
5. Clinical and Laboratory Standards Institute (CLSI). H26-A2: validation, verification and quality assurance of automated hematology analyzers, 2nd ed. Wayne (PA): CLSI document; 2010.