About: Validation of a commercially available SARS-CoV-2 serological Immunoassay

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About: Validation of a commercially available SARS-CoV-2 serological Immunoassay Goto Sponge NotDistinct Permalink

An Entity of Type : schema:ScholarlyArticle, within Data Space : wasabi.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	Validation of a commercially available SARS-CoV-2 serological Immunoassay
Creator	Kaiser, Laurent Meyer, Benjamin Eckerle, Isabella Zimmer, Gert Pugin, Jérôme Siegrist, Claire-Anne Yerly, Sabine Agoritsas, Thomas Guessous, Idris Stringhini, Silvia Calame, Adrien Fontao, Lionel Mazza, Lena Torriani, Giulia Stirnemann, Jérôme Arm-Vernez, Roux-5 Lombard, Pascale Spechbach, Vuilleumier,
Source	MedRxiv
abstract	Aims: To validate the diagnostic accuracy of a Euroimmun SARS-CoV-2 IgG and IgA immunoassay for COVID-19 disease. Methods: In this unmatched (1:1) case-control validation study, we used sera of 181 laboratory-confirmed SARS-CoV-2 cases and 176 negative controls collected before the emergence of SARS-CoV-2. Diagnostic accuracy of the immunoassay was assessed against a whole spike protein-based recombinant immunofluorescence assay (rIFA) by receiver operating characteristic (ROC) analyses. Discrepant cases between ELISA and rIFA were further tested by pseudo-neutralization assay. Results: COVID-19 patients were more likely to be male and older than controls, and 50.3% of them were hospitalized. ROC curve analyses indicated that IgG and IgA had a high diagnostic accuracy with AUCs of 0.992 (95% Confidence Interval [95%CI]: 0.986-0.996) and 0.977 (95%CI: 0.963-0.990), respectively. IgG assays outperformed IgA assays (p=0.008). Considering optimized cut-offs taking the 15% inter-assay imprecision assessed into account, an IgG ratio cut-off > 1.5 displayed a 100% specificity (95%CI: 98-100) and a 100% positive predictive value (95%CI: 97-100). A 0.5 cut-off displayed a 97% sensitivity (95%CI: 93-99) and a 97% negative predictive value (95%CI: 93-99). Adopting these thresholds, rather than those of the manufacturer, improved assay performance, leaving 12% of IgG ratios ranging between 0.5-1.5 as indeterminate. Conclusions: The Euroimmun assay displays a nearly optimal diagnostic accuracy using IgG against SARS-CoV-2 in a samples of patients, without any obvious gains from considering IgA serology. The optimized cut-offs are fit for rule-in and rule-out purposes, allowing determination of whether individuals have been exposed to SARS-CoV-2 or not in our study population. They should however not be considered as a surrogate of protection at this stage.
has issue date	2020-05-06(xsd:dateTime)
bibo:doi	10.1101/2020.05.02.20080879
has license	medrxiv
sha1sum (hex)	df1f8d510066c8d95a8482ed526fddcef4e0aced
schema:url	https://doi.org/10.1101/2020.05.02.20080879
resource representing a document's title	Validation of a commercially available SARS-CoV-2 serological Immunoassay
resource representing a document's body	covid:df1f8d510066c8d95a8482ed526fddcef4e0aced#body_text
is schema:about of	named entity 'serological' named entity 'SARS-COV-2' named entity 'infection' named entity 'IgA' named entity 'NPV' named entity 'confidence intervals' named entity 'SARS-CoV-2' named entity 'seroprevalence' named entity 'cross-reactivity' named entity 'seropositivity' named entity 'centrifugation' named entity 'SARS-CoV-2' named entity 'cut-off' named entity 'B cell' named entity 'seropositivity' named entity 'medRxiv' named entity 'preprint' named entity 'PPV' named entity 'SARS-CoV-2' named entity 'IgA' named entity 'protein' named entity 'COVID' named entity 'cut-off' named entity 'case-control' named entity 'preprint' named entity 'seroprevalence' named entity 'seroconversion' named entity 'SARS-CoV-2' named entity 'ROC curve' named entity 'preprint' named entity 'IgG' named entity 'preprint' named entity 'complement' named entity 'cut-off' named entity 'cut-off' named entity 'IgA' named entity 'PCR' named entity 'PPV' named entity 'preprint' named entity 'HKU1' named entity 'preprint' named entity 'medRxiv' named entity 'preprint' named entity 'Serological' named entity 'epidemic' named entity 'immunofluorescence assay' named entity 'preprint' named entity 'peer review' named entity 'virus' named entity 'IgA' named entity 'IgG' named entity 'serological' named entity 'cut-offs' named entity 'seroprevalence' named entity 'common colds' named entity 'pre-test probability' named entity 'viral disease' named entity 'Geneva University Hospitals' named entity 'cut-offs' named entity 'seropositivity' named entity 'medRxiv' named entity 'NPV' named entity 'incubation' named entity 'IgG' named entity 'PPV' named entity 'immunofluorescence assay' named entity 'seropositivity'

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