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Performance of 30 commercial SARS-CoV-2 serology assays in testing symptomatic COVID-19 patients

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Vauloup-Fellous, Christelle | Maylin, Sarah | Périllaud-Dubois, Claire | Brichler, Ségolène | Alloui, Chakib | Gordien, Emmanuel | Rameix-Welti, Marie-Anne | Gault, Elyanne | Moreau, Frédérique | Fourati, Slim | Challine, Dominique | Pawlotsky, Jean-Michel | Houhou-Fidouh, Nadhira | Damond, Florence | Mackiewicz, Vincent | Charpentier, Charlotte | Méritet, Jean-François | Rozenberg, Flore | Podglajen, Isabelle | Marot, Stéphane | Petit, Heloïse | Burrel, Sonia | Akhavan, Sepideh | Leruez-Ville, Marianne | Avettand-Fenoel, Véronique | Fourgeaud, Jacques | Guilleminot, Tiffany | Gardiennet, Elise | Bonacorsi, Stéphane | Carol, Agnès | Carcelain, Guislaine | Villemonteix, Juliette | Boukli, Narjis | Gozlan, Joël | Morand-Joubert, Laurence | Legoff, Jérome | Delaugerre, Constance | Chaix, Marie-Laure | Roque-Afonso, Ana-Maria | Dortet, Laurent | Naas, Thierry | Ronat, Jean-Baptiste | Lepape, Samuel | Marcelin, Anne-Geneviève | Descamps, Diane

Edité par CCSD ; Springer Verlag -

International audience. 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.

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