Hottentraeger, Barbara and Hagedorn, Hans-Jochen and Baecker, Eugen and Bleekmann, Barbara and Gessner, Andre and Luebke, Nadine and Wenzel, Juergen J. and Widera, Marek and Pabinger, Stephan and Ramge, Peter and Timm, Joerg (2021) Multicenter Performance Evaluation of Elecsys Anti-HBc II, Anti- HCV II, HIV combi PT, HBsAg II, and Syphilis Immunoassays. CLINICAL LABORATORY, 67 (11). pp. 2594-2599. ISSN 1433-6510,
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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 (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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | POPULATIONS; hepatitis B virus; hepatitis C virus; human immunodeficiency virus; sensitivity; specificity; syphilis |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Medizinische Mikrobiologie und Hygiene |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 20 Sep 2022 05:21 |
| Last Modified: | 20 Sep 2022 05:21 |
| URI: | https://pred.uni-regensburg.de/id/eprint/47580 |
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