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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

임상검사와정도관리 2020년 42권 3호 p.150 ~ 155
유재은, 손범세, 한은희, 유경기, 이승옥,
소속 상세정보
유재은 ( Yoo Jae-Eun ) - Catholic University College of Medicine Incheon St. Mary’s Hospital Department of Laboratory Medicine
손범세 ( Son Beom-Se ) - Catholic University College of Medicine Incheon St. Mary’s Hospital Department of Laboratory Medicine
한은희 ( Han Eun-Hee ) - Catholic University College of Medicine Incheon St. Mary’s Hospital Department of Laboratory Medicine
유경기 ( Yu Gyong-Gi ) - Catholic University College of Medicine Incheon St. Mary’s Hospital Department of Laboratory Medicine
이승옥 ( Lee Seung-Ok ) - Catholic University College of Medicine Incheon St. Mary’s Hospital Department of Laboratory Medicine

Abstract


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.

키워드

Hepatitis B virus; Hepatitis C virus; DNA; RNA; Quantification test

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