Diagnostic accuracy of Augurix COVID-19 IgG serology rapid test.
Aged
Antibodies, Viral
/ immunology
Betacoronavirus
/ immunology
COVID-19
COVID-19 Testing
COVID-19 Vaccines
Case-Control Studies
Clinical Laboratory Techniques
Coronavirus Infections
/ diagnosis
Female
Fluorescent Antibody Technique
Humans
Immunoglobulin G
/ immunology
Immunoglobulin M
/ immunology
Male
Middle Aged
Pandemics
Pneumonia, Viral
/ diagnosis
Reverse Transcriptase Polymerase Chain Reaction
SARS-CoV-2
Sensitivity and Specificity
Serologic Tests
Spike Glycoprotein, Coronavirus
/ immunology
Covid-19 serology
IgG
Immunofluorescence assay
SARS-CoV-2
rapid test
Journal
European journal of clinical investigation
ISSN: 1365-2362
Titre abrégé: Eur J Clin Invest
Pays: England
ID NLM: 0245331
Informations de publication
Date de publication:
Oct 2020
Oct 2020
Historique:
received:
05
06
2020
revised:
13
07
2020
accepted:
17
07
2020
pubmed:
22
7
2020
medline:
3
10
2020
entrez:
22
7
2020
Statut:
ppublish
Résumé
To validate the diagnostic accuracy of the Augurix SARS-CoV-2 IgM/IgG rapid immunoassay diagnostic test (RDT) for COVID-19. In this unmatched 1:1 case-control study, blood samples from 46 real-time RT-PCR-confirmed SARS-CoV-2 hospitalized cases and 45 healthy donors (negative controls) were studied. Diagnostic accuracy of the IgG RDT was assessed against both an in-house recombinant spike-expressing immunofluorescence assay (rIFA), as an established reference method (primary endpoint), and the Euroimmun SARS-CoV-2 IgG enzyme-linked immunosorbent assays (ELISA) (secondary endpoint). COVID-19 patients were more likely to be male (61% vs 20%; P = .0001) and older (median 66 vs 47 years old; P < .001) than controls. Whole blood IgG-RDT results showed 86% and 93% overall Kendall concordance with rIFA and IgG ELISA, respectively. IgG RDT performances were similar between plasma and whole blood. Overall, RDT sensitivity was 88% (95% confidence interval [95%CI]: 70-96), specificity 98% (95%CI: 90-100), PPV 97% (95%CI: 80-100) and NPV 94% (95%CI: 84-98). The IgG-RDT carried out from 0 to 6 days, 7 to 14 days and > 14 days after the SARS-CoV-2 RT-PCR test displayed 30%, 73% and 100% positivity rates in the COVID-19 group, respectively. When considering samples taken >14 days after RT-PCR diagnosis, NPV was 100% (95%CI:90-100), and PPV was 100% (95%CI:72-100). The Augurix IgG-RDT done in whole blood displays a high diagnostic accuracy for SARS-CoV-2 IgG in high COVID-19 prevalence settings, where its use could be considered in the absence of routine diagnostic serology facilities.
Identifiants
pubmed: 32691863
doi: 10.1111/eci.13357
pmc: PMC7404380
doi:
Substances chimiques
Antibodies, Viral
0
COVID-19 Vaccines
0
Covid-19 aAPC vaccine
0
Immunoglobulin G
0
Immunoglobulin M
0
Spike Glycoprotein, Coronavirus
0
spike protein, SARS-CoV-2
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e13357Commentaires et corrections
Type : CommentIn
Informations de copyright
© 2020 Stichting European Society for Clinical Investigation Journal Foundation. Published by John Wiley & Sons Ltd.
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