Lab Med Qual Assur.  2020 Sep;42(3):150-155. 10.15263/jlmqa.2020.42.3.150.

Performance Evaluations of the Abbott Alinity m Assay in Comparison with the Abbott m2000 Assay for Hepatitis B and Hepatitis C Viruses

• Yoo J
• Son BS
• Han E
• Yu GG
• Lee S

• KMID: 2506967
• DOI: http://doi.org/10.15263/jlmqa.2020.42.3.150

Abstract

ackground: 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.

Keyword

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