Performance Evaluations of the Abbott Alinity m Assay in Comparison with the Abbott m2000Assay for Hepatitis B and Hepatitis C Viruses

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.