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

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An Entity of Type : schema:ScholarlyArticle, within Data Space : covidontheweb.inria.fr associated with source document(s)

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Clinical evaluation of five different automated SARS-CoV-2 serology assays in a cohort of hospitalized COVID-19 patients
Creator	Kluge, Stefan Lütgehetmann, Marc Pfefferle, Susanne Aepfelbacher, Martin Addo, Marylyn Lohse, Ansgar Bannasch, Johannes Brehm, Thomas Haddad, Monif Hiller, Jens Hoffmann, Armin Nörz, Dominik Peine, Sven Pflüger, Lisa Pischke, Sven Schulze Zur Wiesch, Julian Van Der Meirschen, Marc
Source	Elsevier; Medline; PMC
abstract	BACKGROUND: 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. METHODS: 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. RESULTS: 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 (r(2) = 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). CONCLUSION: 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.
has issue date	2020-07-17(xsd:dateTime)
bibo:doi	10.1016/j.jcv.2020.104549
bibo:pmid	32763809
has license	no-cc
sha1sum (hex)	04afa5b2f72f9d797fbb09e8070ac65249b528d1
schema:url	https://doi.org/10.1016/j.jcv.2020.104549
resource representing a document's title	Clinical evaluation of five different automated SARS-CoV-2 serology assays in a cohort of hospitalized COVID-19 patients
has PubMed Central identifier	PMC7367003
has PubMed identifier	32763809
schema:publication	J Clin Virol
resource representing a document's body	covid:04afa5b2f72f9d797fbb09e8070ac65249b528d1#body_text
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