Performance Evaluations of the Abbott Alinity m Assay in Comparison with the Abbott m2000Assay for Hepatitis B and Hepatitis C Viruses
10.15263/jlmqa.2020.42.3.150
- Author:
Jaeeun YOO
1
;
Beom Se SON
;
Eunhee HAN
;
Gyong Gi YU
;
Seungok LEE
Author Information
1. Department of Laboratory Medicine, Incheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Incheon, Korea
- Publication Type:Original Article
- From:Journal of Laboratory Medicine and Quality Assurance
2020;42(3):150-155
- CountryRepublic of Korea
- Language:Korean
-
Abstract:
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.
