Abstract
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Multicenter Performance Evaluation of Elecsys Anti-HBc II, Anti-HCV II, HIV combi PT, HBsAg II, and Syphilis Immunoassays
by Barbara Hottenträger, Hans-Jochen Hagedorn, Eugen Bäcker, Barbara Bleekmann, Andre Gessner, Nadine Lübke, Jürgen J. Wenzel, Marek Widera,
Stephan Pabinger, Peter Ramge, Jörg Timm
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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® 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 antihepatitis 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.
DOI: 10.7754/Clin.Lab.2021.210201
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