2021
DOI: 10.1007/s10096-021-04232-3
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Performance of 30 commercial SARS-CoV-2 serology assays in testing symptomatic COVID-19 patients

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 performance… Show more

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Cited by 12 publications
(9 citation statements)
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References 20 publications
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“… 33 False positives are rare and may relate to cross-seropositivity with other coronaviruses or infectious agents or the presence of rheumatoid factor. 34 In our study, the possibility of centralised analysis of the samples is a strength to allow good reproducibility in the detection and quantification of anti-SARS-CoV-2 antibodies and an asset for the longitudinal follow-up, which is planned until 1 year.…”
Section: Discussionmentioning
confidence: 99%
“… 33 False positives are rare and may relate to cross-seropositivity with other coronaviruses or infectious agents or the presence of rheumatoid factor. 34 In our study, the possibility of centralised analysis of the samples is a strength to allow good reproducibility in the detection and quantification of anti-SARS-CoV-2 antibodies and an asset for the longitudinal follow-up, which is planned until 1 year.…”
Section: Discussionmentioning
confidence: 99%
“…There are other published evaluation reports that have similarly shown poor serological RDT performance compared to that reported by the manufacturer (Deeks et al 2020;Jacobs et al 2020;Vauloup-Fellous et al 2021). Since some of these other studies used samples from any qRT-PCR positive individuals, they show lower sensitivity in the first week post symptom onset with improved performance at later time points.…”
Section: Discussionmentioning
confidence: 91%
“…It was decided to perform different determinations previously checked in the Microbiology Department due to the disparity in the ndings re ected in some studies [17].…”
Section: Methodsmentioning
confidence: 99%