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

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.

Automated summary

This study evaluated the clinical performances of 30 COVID-19 assays, with only 4 rapid tests and 3 automated/manual tests meeting specified criteria. Serology provides valuable information during the COVID-19 pandemic, but inconsistent performances were observed among the evaluated commercial assays.