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. 2021 Oct;40(10):2235-2241.
doi: 10.1007/s10096-021-04232-3. Epub 2021 Mar 29.

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  3 , Ségolène Brichler  4   5 , Chakib Alloui  4   5 , Emmanuel Gordien  4   5 , Marie-Anne Rameix-Welti  6   7 , Elyanne Gault  6   7 , Frédérique Moreau  6   7 , Slim Fourati  8 , Dominique Challine  8 , Jean-Michel Pawlotsky  8 , Nadhira Houhou-Fidouh  9 , Florence Damond  9 , Vincent Mackiewicz  9 , Charlotte Charpentier  9 , Jean-François Méritet  10 , Flore Rozenberg  10 , Isabelle Podglajen  11 , Stéphane Marot  12 , Heloïse Petit  12 , Sonia Burrel  12 , Sepideh Akhavan  12 , Marianne Leruez-Ville  13 , Véronique Avettand-Fenoel  13 , Jacques Fourgeaud  13 , Tiffany Guilleminot  13 , Elise Gardiennet  13 , Stéphane Bonacorsi  14 , Agnès Carol  14 , Guislaine Carcelain  15 , Juliette Villemonteix  15 , Narjis Boukli  16 , Joël Gozlan  16 , Laurence Morand-Joubert  16 , Jérome Legoff  2 , Constance Delaugerre  2 , Marie-Laure Chaix  2 , Ana-Maria Roque-Afonso  3 , Laurent Dortet  17 , Thierry Naas  17 , Jean-Baptiste Ronat  17 , Samuel Lepape  3 , Anne-Geneviève Marcelin  12 , Diane Descamps  9
Affiliations

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

Christelle Vauloup-Fellous et al. Eur J Clin Microbiol Infect Dis. 2021 Oct.

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.

Keywords: COVID-19; SARS-CoV-2; Serology.

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Conflict of interest statement

JM Pawlotsky has served as an advisor and/or a speaker for Abbvie, Gilead, GlaxoSmithKline, Merck, Regulus and Siemens Healthcare

C Vauloup-Fellous served as an expert (rubella and CMV serology) for Abbott Diagnostics, Roche Diagnostics, Siemens Healthcare, and DiaSorin, outside the submitted work.

Dr. Charpentier reports personal fees from Gilead Sciences, personal fees from ViiV Healthcare, from MSD, outside the submitted work.

Dr. Marcelin reports grants and personal fees from VIIV Healthcare, grants and personal fees from Gilead, grants and personal fees from MSD, outside the submitted work.

Pr Laurence Morand-Joubert has received honoraria for advisories or invited talks or conferences from Gilead Sciences, Merck Laboratories MSD, Janssen Pharmaceuticals, and ViiV Healthcare and grants from ANRS, outside the submitted work

Dr. Avettand-Fenoel reports grants and personal fees from Viiv healthcare, other from Janssen, other from Roche, outside the submitted work

Figures

Fig. 1
Fig. 1
Global performances of immunoassays: rapid tests for qualitative detection of anti-SARS-CoV-2 antibodies (RDTs) (white background), and automated/manual ELISA/CLIA assays (IAs) (gray background). All error bars represent 95% confidence interval. Number of samples tested (N) is specified for each assay. a Specificity (black line represents the minimum expected specificity (98%) according to French recommendations [9]). b Percent of samples tested positive to time after onset of symptoms: 0–9 days, 10–14 days, and more than 14 days after onset of symptoms (median 22 days) (black line represents the minimum expected sensitivity (90%) according to French recommendations [9]). Areas where no data are shown correspond to assays that only detect IgG
Fig. 2
Fig. 2
IgG results of immunoassays: rapid tests for qualitative detection of anti-SARS-CoV-2 antibodies (RDTs) (white background) and automated/manual ELISA/CLIA assays (IAs) (gray background). All error bars represent 95% confidence interval. Number of samples tested (N) is specified for each assay. a Specificity (black line represents the minimum expected specificity (98%) according to French recommendations [9]). b Percent of samples tested positive to time after onset of symptoms: 0–9 days, 10–14 days, and more than 14 days after onset of symptoms (median 22 days) (black line represents the minimum expected sensitivity (90%) according to French recommendations [9]). Areas where no data are shown correspond to assays that only detect TAb
Fig. 3
Fig. 3
IgM/IgA results of immunoassays: rapid tests for qualitative detection of anti-SARS-CoV-2 antibodies (RDTs) (white background) and automated/manual ELISA/CLIA assays (IAs) (gray background). All error bars represent 95% confidence interval. Number of samples tested (N) is specified for each assay. a Specificity (black line represents the minimum expected specificity (98%) according to French recommendations [9]). b Percent of samples tested positive to time after onset of symptoms: 0–9 days, 10–14 days, and more than 14 days after onset of symptoms (median 22 days) (black line represents the minimum expected sensitivity (90%) according to French recommendations [9]). Areas where no data are shown correspond to assays that do not detect IgM nor IgA
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