• J. Clin. Virol. · Sep 2020

    Clinical evaluation of five different automated SARS-CoV-2 serology assays in a cohort of hospitalized COVID-19 patients.

    • Lisa Sophie Pflüger, Johannes H Bannasch, Thomas Theo Brehm, Susanne Pfefferle, Armin Hoffmann, Dominik Nörz, Marc van der Meirschen, Stefan Kluge, Munif Haddad, Sven Pischke, Jens Hiller, Marylyn M Addo, Ansgar W Lohse, Julian Schulze Zur Wiesch, Sven Peine, Martin Aepfelbacher, and Marc Lütgehetmann.
    • Center for Diagnostics, Institute of Medical Microbiology, Virology and Hygiene, University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany; Division of Infectious Diseases, I. Department of Internal Medicine, University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.
    • J. Clin. Virol. 2020 Sep 1; 130: 104549.

    BackgroundThe global market for SARS-CoV-2-immunoassays is becoming ever more crowded with antibody-tests of various formats, targets and technologies, careful evaluation is crucial for understanding the implications of individual test results. Here, we evaluate the clinical performance of five automated immunoassays on a set of clinical samples.MethodsSerum/plasma samples of 75 confirmed COVID-19 patients and 320 pre-pandemic serum samples of healthy blood donors were subjected to two IgG and three total antibody SARS-CoV-2-immunoassays. All test setups were automated workflows.ResultsPositivity of assays (onset of symptoms > 10 days) ranged between 68.4 % and 81.6 % (Diasorin 68.4 %, Euroimmun 70.3 %, Siemens 73.7 %, Roche 79.0 % and Wantai 81.6 %). All examined assays demonstrated high specificity of >99 % (Euroimmun, Diasorin: 99.1 %, Wantai: 99.4 %) but only two reached levels above 99.5 % (Roche: 99.7 %, Siemens 100 %). Interestingly, there was no overlap in false positive results between the assays. The strongest correlation of quantitative results was observed between the Diasorin and Euroimmun IgG tests (r2 = 0.76). Overall, we observed no difference in the distribution of test results between female and male patients (p-values: 0.18-0.87). A significant difference between severely versus critically ill patients was demonstrated for the Euroimmun, Diasorin, Wantai and Siemens assays (p-values:0.041).ConclusionAll assays showed good clinical performance. Our data confirm that orthogonal test strategies as recommended by the CDC can enhance clinical specificity. However, the suboptimal rates of test positivity found at time of hospitalization in this cohort underline the importance of molecular diagnostics to rule out/confirm active infection with SARS-CoV-2.Copyright © 2020 Elsevier B.V. All rights reserved.

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