Performance of 30 commercial SARS-CoV-2 serology assays in testing symptomatic COVID-19 patients
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Claire Périllaud-Dubois
- Function : Author
- PersonId : 1057457
Jean-Michel Pawlotsky
- Function : Author
- PersonId : 757187
- ORCID : 0000-0003-0745-7559
- IdRef : 07655130X
Flore Rozenberg
- Function : Author
- PersonId : 759620
- ORCID : 0000-0003-0991-7774
- IdRef : 089425561
Stéphane Marot
- Function : Author
- PersonId : 802937
- ORCID : 0000-0003-4438-5793
Sonia Burrel
- Function : Author
- PersonId : 777590
- ORCID : 0000-0002-7783-2601
- IdRef : 144712326
Véronique Avettand-Fenoel
- Function : Author
- PersonId : 765802
- ORCID : 0000-0002-7022-2990
- IdRef : 09320955X
Juliette Villemonteix
- Function : Author
- PersonId : 783945
- ORCID : 0000-0002-6601-7820
Laurent Dortet
- Function : Author
- PersonId : 763356
- ORCID : 0000-0001-6596-7384
- IdRef : 131835459
Thierry Naas
- Function : Author
- PersonId : 797178
- ORCID : 0000-0001-9937-9572
- IdRef : 192382748
Anne-Geneviève Marcelin
- Function : Author
- PersonId : 759805
- ORCID : 0000-0003-4808-8999
- IdRef : 089079566
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.