About: Analytical and clinical validation of an ELISA for specific SARS‐CoV‐2 IgG, IgA, and IgM antibodies

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About: Analytical and clinical validation of an ELISA for specific SARS‐CoV‐2 IgG, IgA, and IgM antibodies Goto Sponge NotDistinct Permalink

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	Analytical and clinical validation of an ELISA for specific SARS‐CoV‐2 IgG, IgA, and IgM antibodies
Creator	Beukinga, Ingrid Tré-Hardy, Marie Wilmet, Alain Douxfils, Jonathan Favresse, Julien Dogné, Jean-Michel Bouge, St-Luc Laurent Blairon, \| Sa, Qualiblood
Source	Medline; PMC
abstract	The development of severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) serological tests is massive. The external validation of their performance is needed before use in clinical routine practice. Our study aims at assessing the analytical and clinical performance of two enzyme‐linked immunosorbent assay tests detecting antibodies directed against the virus nucleocapsid protein: The NovaLisa SARS‐CoV‐2 immunoglobulin G (IgG), immunoglobulin A (IgA), and immunoglobulin M (IgM) test (NovaTec) allowing a separate detection of each antibody and the Platelia SARS‐CoV‐2 Total Ab test (Bio‐Rad) detecting total antibodies (IgM, IgA, and IgG). Two‐hundred and eight coronavirus disease 2019 samples from 48 quantitative reverse transcription‐polymerase chain reaction (RT‐qPCR) confirmed patients were used to perform the sensitivity analysis. Non‐SARS‐CoV‐2 sera (n = 79) with a potential cross‐reaction to SARS‐CoV‐2 immunoassays were included in the specificity analysis. In addition, using receiver operator characteristic curves, adapted cut‐off for improvement of the performances were proposed. The kinetics of these antibodies was also assessed over 8 weeks. Two weeks after the RT‐qPCR positive detection, the NovaLisa test shows a sensitivity and specificity of 94.9% (95% confidence interval [CI]: 83.1%‐98.6%) and 96.2% (95% CI: 89.4%‐98.7%) for IgG, of 89.7% (95% CI: 76.4%‐95.9%) and 98.7% (95% CI: 93.2%‐98.8%) for IgA, and of 48.7% (95% CI: 33.9%‐63.8%) and 98.7% (95% CI: 93.2%‐99.8%) for IgM. With the Platelia system, the specificity and sensitivity were 97.4% (95% CI: 92.1%‐99.7%) and 94.9% (95% CI: 87.7%‐98.0%) for total antibodies using the adapted cut‐offs. The NovaLisa and the Platelia tests have satisfactory analytical performances. The clinical performances are excellent for IgG, IgA, and total antibodies especially if the cut‐off is optimized.
has issue date	2020-07-27(xsd:dateTime)
bibo:doi	10.1002/jmv.26303
bibo:pmid	32667733
has license	no-cc
sha1sum (hex)	c0bac4996407b07bc1c3fd5ba454d75a4145f95e
schema:url	https://doi.org/10.1002/jmv.26303
resource representing a document's title	Analytical and clinical validation of an ELISA for specific SARS‐CoV‐2 IgG, IgA, and IgM antibodies
has PubMed Central identifier	PMC7405491
has PubMed identifier	32667733
schema:publication	J Med Virol
resource representing a document's body	covid:c0bac4996407b07bc1c3fd5ba454d75a4145f95e#body_text
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