PT  - JOURNAL ARTICLE
AU  - Aurelie Velay
AU  - Floriane Gallais
AU  - Ilies Benotmane
AU  - Marie Josée Wendling
AU  - François Danion
AU  - Olivier Collange
AU  - Jérôme De Sèze
AU  - Catherine Schmidt-Mutter
AU  - Francis Schneider
AU  - Pascal Bilbault
AU  - Ferhat Meziani
AU  - Samira Fafi-Kremer
TI  - Evaluation of the performance of SARS-CoV-2 serological tools and their positioning in COVID-19 diagnostic strategies
AID  - 10.1101/2020.06.16.156166
DP  - 2020 Jan 01
TA  - bioRxiv
PG  - 2020.06.16.156166
4099  - http://biorxiv.org/content/early/2020/06/19/2020.06.16.156166.short
4100  - http://biorxiv.org/content/early/2020/06/19/2020.06.16.156166.full
AB  - Rapid and accurate diagnosis is crucial for successful outbreak containment. During the current coronavirus disease 2019 (COVID-19) public health emergency, the gold standard for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection diagnosis is the detection of viral RNA by reverse transcription (RT)-PCR. Additional diagnostic methods enabling the detection of current or past SARS-CoV-2 infection would be highly beneficial to ensure the timely diagnosis of all infected and recovered patients. Here, we investigated several serological tools, i.e., two immunochromatographic lateral flow assays (LFA-1 (Biosynex COVID-19 BSS) and LFA-2 (COVID-19 Sign IgM/IgG)) and two enzyme-linked immunosorbent assays (ELISAs) detecting IgA (ELISA-1 Euroimmun), IgM (ELISA-2 EDI) and/or IgG (ELISA-1 and ELISA-2) based on well-characterized panels of serum samples from patients and healthcare workers with PCR-confirmed COVID-19 and from SARS-CoV-2-negative patients. A total of 272 serum samples were used, including 62 serum samples from hospitalized patients (panel 1 and panel 3), 143 serum samples from healthcare workers (panel 2) diagnosed with COVID-19 and 67 serum samples from negative controls. Diagnostic performances of each assay were assessed according to days after symptom onset (dso) and the antigenic format used by manufacturers. We found overall sensitivities ranging from 69% to 93% on panels 1 and 2 and specificities ranging from 83% to 98%. The clinical sensitivity varied greatly according to the panel tested and the dso. The assays we tested showed poor mutual agreement. A thorough selection of serological assays for the detection of ongoing or past infections is advisable.COVID-19coronavirus disease 2019;dsodays after symptom onset;ELISAenzyme-linked immunosorbent assays;LFAlateral flow assays;RT-PCRreverse transcription (RT-) polymerase chain reaction (PCR);SARS-CoV-2severe acute respiratory syndrome coronavirus 2