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DOI 10.1007/s10096-021-04232-3

Медицинская библиотека · European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2021

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

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

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Аннотация

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.

Для цитирования: 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. Performance of 30 commercial SARS-CoV-2 serology assays in testing symptomatic COVID-19 patients.. European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology. 2021. DOI: 10.1007/s10096-021-04232-3.

Предметные рубрики MeSH

Antibodies, ViralCOVID-19COVID-19 Serological TestingHumansImmunoassayImmunoglobulin MReagent Kits, DiagnosticSARS-CoV-2Sensitivity and Specificity
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