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

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. On...

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Detalles Bibliográficos
Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8007057/
https://www.ncbi.nlm.nih.gov/pubmed/33782783
http://dx.doi.org/10.1007/s10096-021-04232-3
Descripción
Sumario: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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s10096-021-04232-3.