Performance of 30 commercial SARS-CoV-2 serology assays in testing symptomatic COVID-19 patients.
COVID-19
SARS-CoV-2
Serology
Journal
European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology
ISSN: 1435-4373
Titre abrégé: Eur J Clin Microbiol Infect Dis
Pays: Germany
ID NLM: 8804297
Informations de publication
Date de publication:
Oct 2021
Oct 2021
Historique:
received:
13
01
2021
accepted:
17
03
2021
pubmed:
31
3
2021
medline:
28
9
2021
entrez:
30
3
2021
Statut:
ppublish
Résumé
We report evaluation of 30 assays' (17 rapid tests (RDTs) and 13 automated/manual ELISA/CLIA assay (IAs)) clinical performances with 2594 sera collected from symptomatic patients with positive SARS-CoV-2 rRT-PCR on a respiratory sample, and 1996 pre-epidemic serum samples expected to be negative. Only 4 RDT and 3 IAs fitted both specificity (> 98%) and sensitivity (> 90%) criteria according to French recommendations. Serology may offer valuable information during COVID-19 pandemic, but inconsistent performances observed among the 30 commercial assays evaluated, which underlines the importance of independent evaluation before clinical implementation.
Identifiants
pubmed: 33782783
doi: 10.1007/s10096-021-04232-3
pii: 10.1007/s10096-021-04232-3
pmc: PMC8007057
doi:
Substances chimiques
Antibodies, Viral
0
Immunoglobulin M
0
Reagent Kits, Diagnostic
0
Types de publication
Evaluation Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
2235-2241Informations de copyright
© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.
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