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

Christelle Vauloup-Fellous 1 Sarah Maylin 2 Claire Périllaud-Dubois 1 Ségolène Brichler 3, 4 Chakib Alloui 3, 4 Emmanuel Gordien 3, 4 Marie-Anne Rameix-Welti 5, 6 Elyanne Gault 5, 6 Frédérique Moreau 5, 6 Slim Fourati 4 Dominique Challine 4 Jean-Michel Pawlotsky 4 Nadhira Houhou-Fidouh 7 Florence Damond 7 Vincent Mackiewicz 7 Charlotte Charpentier 7 Jean-François Méritet 8 Flore Rozenberg 8 Isabelle Podglajen 9 Stéphane Marot 10 Heloïse Petit 10 Sonia Burrel 10 Sepideh Akhavan 10 Marianne Leruez-Ville 11 Véronique Avettand-Fenoel 11 Jacques Fourgeaud 11 Tiffany Guilleminot 11 Elise Gardiennet 11 Stéphane Bonacorsi 12 Agnès Carol 12 Guislaine Carcelain 13 Juliette Villemonteix 13 Narjis Boukli 10 Joël Gozlan 10 Laurence Morand-Joubert 10 Jérome Legoff 2 Constance Delaugerre 2 Marie-Laure Chaix 2 Ana-Maria Roque-Afonso 1 Laurent Dortet 14 Thierry Naas 14 Jean-Baptiste Ronat 14 Samuel Lepape 1 Anne-Geneviève Marcelin 10 Diane Descamps 7
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.
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https://www.hal.inserm.fr/inserm-03227584
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Submitted on : Monday, May 17, 2021 - 2:01:55 PM
Last modification on : Wednesday, October 27, 2021 - 4:01:59 PM

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Christelle Vauloup-Fellous, Sarah Maylin, Claire Périllaud-Dubois, Ségolène Brichler, Chakib Alloui, et al.. Performance of 30 commercial SARS-CoV-2 serology assays in testing symptomatic COVID-19 patients. European Journal of Clinical Microbiology and Infectious Diseases, Springer Verlag, 2021, Online ahead of print. ⟨10.1007/s10096-021-04232-3⟩. ⟨inserm-03227584⟩

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