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

•Clinical performance of five different commercially available automated SARS-CoV-2 antibody tests.•No overlap of “false” positive samples between different serology assays was observed.•The ability to rule out acute SARS-CoV-2 infection at hospital admission with serology is limited. The global mar...

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Veröffentlicht in:Journal of clinical virology 2020-09, Vol.130, p.104549-104549, Article 104549
Hauptverfasser: Pflüger, Lisa Sophie, Bannasch, Johannes H., Brehm, Thomas Theo, Pfefferle, Susanne, Hoffmann, Armin, Nörz, Dominik, van der Meirschen, Marc, Kluge, Stefan, Haddad, Munif, Pischke, Sven, Hiller, Jens, Addo, Marylyn M., Lohse, Ansgar W., Schulze zur Wiesch, Julian, Peine, Sven, Aepfelbacher, Martin, Lütgehetmann, Marc
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Sprache:eng
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Zusammenfassung:•Clinical performance of five different commercially available automated SARS-CoV-2 antibody tests.•No overlap of “false” positive samples between different serology assays was observed.•The ability to rule out acute SARS-CoV-2 infection at hospital admission with serology is limited. The 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. Serum/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. Positivity 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). All 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.
ISSN:1386-6532
1873-5967
DOI:10.1016/j.jcv.2020.104549