Multicenter Performance Evaluation of Elecsys Anti-HBc II, Anti- HCV II, HIV combi PT, HBsAg II, and Syphilis Immunoassays

Background: The WHO recommends mandatory serological testing of blood donors for hepatitis B virus, hepatitis C virus (HCV), human immunodeficiency virus (HIV), and syphilis. We evaluated the performance of Elecsys (R) infectious disease immunoassays against commercially available comparator assays. Methods: Prospective, routine, anonymized patient or donor samples (n = 8,821) were analyzed at three German sites using Elecsys anti-hepatitis B core antigen (Anti-HBc II), Anti-HCV II, HIV combi PT, hepatitis B surface antigen (HBsAg II), and Syphilis immunoassays (cobas e 411 analyzer) versus ARCHITECT comparator assays. Results: The Elecsys immunoassays demonstrated comparable sensitivity (<= 1.54% difference) and equivalent specificity (<= 0.63% difference) to the respective ARCHITECT comparator assays. Overall sensitivity for the Elecsys and ARCHITECT infectious disease panels was 99.78% vs. 99.40%, respectively, and overall specificity was 99.74% vs. 99.80%, respectively. Conclusions: The Elecsys infectious disease immunoassays demonstrated high sensitivity and specificity, which were similar to comparator assays, supporting their suitability for routine laboratory practice.