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KMID : 0985420200420030150
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Laboratory Medicine and Quality Assurance
2020 Volume.42 No. 3 p.150 ~ p.155
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Performance Evaluations of the Abbott Alinity m Assay in Comparison with the Abbott m2000 Assay for Hepatitis B and Hepatitis C Viruses
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Yoo Jae-Eun
Son Beom-Se
Han Eun-Hee
Yu Gyong-Gi
Lee Seung-Ok
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Abstract
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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.
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KEYWORD
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Hepatitis B virus, Hepatitis C virus, DNA, RNA, Quantification test
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