Lab Med Qual Assur 2020; 42(3): 150-155
Published online September 30, 2020
Copyright © Korean Association of External Quality Assessment Service.
Jaeeun Yoo1,2, Beom Se Son1, Eunhee Han1,2, Gyong Gi Yu1, and Seungok Lee1,2
1Department of Laboratory Medicine, Incheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Incheon;
2Department of Laboratory Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea
Correspondence to:Seungok Lee
Department of Laboratory Medicine, Incheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, 56 Dongsu-ro, Bupyeong-gu, Incheon 21431, Korea
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Background: The quantification of the hepatitis B virus (HBV) or hepatitis C virus (HCV) is critical for the diagnosis and prognostic follow-up of the viral infection. The Alinity m assay is a recently developed, fully automated “random-access” system for quantitative molecular assays. The aim of this study was to verify the validity of the Alinity m assay by comparing its performance in HBV and HCV quantifications with the established Abbott m2000 HBV and HCV assays.
Methods: The precision, linearity, limit of detection (LOD), correlation with the Abbott m2000 assay, and interference were evaluated.
Results: The within-laboratory standard deviation ranged from 0.106 to 0.137 log IU/mL for HBV and from 0.073 to 0.097 log IU/mL for HCV, which was lower than the manufacturer’s specification of 0.25 log IU/mL, indicating good precision. Linearity was observed from 1.14 to 8.14 log IU/mL for the HBV assay and from 1.09 to 7.09 log IU/mL for the HCV assay. The LODs of HBV and HCV were 10 and 6.39 IU/mL, respectively, which were equivalent to or better than those claimed by the manufacturer. For comparative evaluation between Alinity m and m2000 assays, 142 HBV and 70 HCV samples were tested. The correlation test revealed a strong correlation for both markers, and the Passing–Bablok regression analysis did not reveal any significant deviation.
Conclusions: The Alinity m assay demonstrated excellent performance for HBV and HCV quantifications with reduced hands-on time and a randomaccess format.
Keywords: Hepatitis B virus, Hepatitis C virus, DNA, RNA, Quantification test
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