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

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.