Performance evaluation of the Abbott Alinity Hepatitis C antigen next assay in a US urban emergency department population

Introduction

HCV antibody assays have been used to screen for HCV, but confirmation of acute infection is dependent on RNA or core antigen testing. The aim of the study was to compare the performance of five HCV test methods, including RNA testing, on a US emergency department population.

Methods

Clinical performance metrics were calculated on 708 consenting Johns Hopkins Emergency Department patients who self-reported an increased risk for HCV infection. Detection times of antibody, antigen, and RNA testing were compared using 89 samples from commercially available seroconversion panels. Testing was performed on the Abbott Alinity HCV Ag Next (RUO), Roche Elecsys HCV Duo, Abbott ARCHITECT Anti-HCV, and Elecsys Anti-HCV II assays. RNA testing was performed on the Abbott m2000 system.

Results

Overall, 21 (3.0%) participants tested positive for HCV on at least one test, 11 (52.4%) had chronic, 1 (4.8%) had an acute, and 3 (14.3%) had resolved infections. The Alinity HCV Ag Next assay demonstrated 99.43% specificity when compared to RNA testing. The Alinity HCV Ag Next assay also detected 91.67% of the active infections compared to RNA testing, while the Elecsys HCV Duo Ag assay detected only 58.33%. The seroconversion panel testing demonstrated that the Alinity HCV Ag Next assay detects an infection within 0.8 days of an RNA result.

Conclusion

The Alinity HCV Ag Next assay demonstrated excellent concordance to RNA testing in a US urban E.D. population. This data supports the utility of Alinity HCV Ag Next in diagnosis of active HCV infections.