1. Performance of 30 commercial SARS-CoV-2 serology assays in testing symptomatic COVID-19 patients.
- Author
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Vauloup-Fellous C, Maylin S, Périllaud-Dubois C, Brichler S, Alloui C, Gordien E, Rameix-Welti MA, Gault E, Moreau F, Fourati S, Challine D, Pawlotsky JM, Houhou-Fidouh N, Damond F, Mackiewicz V, Charpentier C, Méritet JF, Rozenberg F, Podglajen I, Marot S, Petit H, Burrel S, Akhavan S, Leruez-Ville M, Avettand-Fenoel V, Fourgeaud J, Guilleminot T, Gardiennet E, Bonacorsi S, Carol A, Carcelain G, Villemonteix J, Boukli N, Gozlan J, Morand-Joubert L, Legoff J, Delaugerre C, Chaix ML, Roque-Afonso AM, Dortet L, Naas T, Ronat JB, Lepape S, Marcelin AG, and Descamps D
- Subjects
- COVID-19 virology, Humans, Immunoassay economics, Immunoglobulin M blood, Reagent Kits, Diagnostic, SARS-CoV-2 genetics, SARS-CoV-2 isolation & purification, Sensitivity and Specificity, Antibodies, Viral blood, COVID-19 blood, COVID-19 Serological Testing methods, Immunoassay methods, SARS-CoV-2 immunology
- Abstract
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., (© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)
- Published
- 2021
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