Evaluation of the EUROIMMUN Anti-SARS-CoV-2 ELISA Assay for detection of IgA and IgG antibodies.
Antibodies, Viral
/ blood
Betacoronavirus
/ immunology
COVID-19
COVID-19 Testing
Chicago
Clinical Laboratory Techniques
/ methods
Coronavirus Infections
/ diagnosis
Enzyme-Linked Immunosorbent Assay
/ methods
Humans
Immunoglobulin A
/ blood
Immunoglobulin G
/ blood
Pandemics
Pneumonia, Viral
/ diagnosis
SARS-CoV-2
Sensitivity and Specificity
Serologic Tests
/ methods
COVID-19
SARS-CoV-2
Serology
Journal
Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology
ISSN: 1873-5967
Titre abrégé: J Clin Virol
Pays: Netherlands
ID NLM: 9815671
Informations de publication
Date de publication:
08 2020
08 2020
Historique:
received:
16
05
2020
accepted:
20
05
2020
pubmed:
3
6
2020
medline:
12
8
2020
entrez:
3
6
2020
Statut:
ppublish
Résumé
As the Coronavirus 2019 (COVID-19) pandemic evolves, the development of immunoassays to help determine exposure and potentially predict immunity has become a pressing priority. In this report we present the performance of the EUROIMMUN enzyme-linked immunosorbent assay (ELISA) for semi-quantitative detection of IgA and IgG antibodies in serum and plasma samples using recombinant S1 domain of the SARS-CoV-2 spike protein as antigen. Specimens from patients, with and without COVID-19 infection, were tested at the University of Chicago Clinical Microbiology and Immunology Laboratory. Of 86 samples from SARS-CoV-2 PCR-negative patients, including 28 samples positive for common human coronavirus strains, 76 tested negative and 10 tested positive for IgA (88.4% agreement, 95% CI: 79.9-93.6) while 84 tested negative and 2 tested positive for IgG (97.7% agreement, 95% CI: 91.9-99.6). Of 82 samples from SARS-CoV-2 PCR-positive patients, 14 tested negative and 68 tested positive for IgA (82.9% agreement, 95% CI: 73.4-89.5) while 27 tested negative and 55 tested positive for IgG (67.1% agreement, 95% CI: 56.3-76.3). Of samples collected ≥4 days after positive PCR, 38 of 42 (90.5% agreement, 95% CI: 77.9-96.2) were positive for IgA, and 42 of 42 (100% agreement, 95% CI: 91.6-100) were positive for IgG, respectively. The EUROIMMUN Anti-SARS-CoV-2 ELISA Assay demonstrated good sensitivity for detection of IgA and excellent sensitivity for detection of IgG antibodies from samples collected ≥4 days, after COVID-19 diagnosis by PCR. This assay demonstrated good specificity for IgA and excellent specificity for IgG and demonstrated only borderline cross reaction in 2 of the 28 samples from patients with common human coronaviruses infection, types NL63 and OC43.
Identifiants
pubmed: 32485620
pii: S1386-6532(20)30210-9
doi: 10.1016/j.jcv.2020.104468
pmc: PMC7255182
pii:
doi:
Substances chimiques
Antibodies, Viral
0
Immunoglobulin A
0
Immunoglobulin G
0
Types de publication
Evaluation Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
104468Informations de copyright
Copyright © 2020 Elsevier B.V. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of competing interest All authors declared no conflict of interest. Study was internally funded.
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