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SARS-CoV-2 proteins

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    Evaluation of the performance of SARS-CoV-2 serological tools and their positioning in COVID-19 MESHD diagnostic strategies.

    Authors: Aurélie Velay; Floriane Gallais; Ilies Benotmane; Marie-Josee Wendling; François Danion; Olivier Collange; Jerome De Seze; Catherine Schmidt-Mutter; Francis Schneider; Pascal Bilbault; Ferhat Meziani; Samira Fafi-Kremer

    doi:10.1101/2020.06.16.156166 Date: 2020-06-19 Source: bioRxiv

    Rapid and accurate diagnosis is crucial for successful outbreak containment. During the current coronavirus disease 2019 MESHD ( COVID-19 MESHD) public health emergency, the gold standard for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection MESHD 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 MESHD would be highly beneficial to ensure the timely diagnosis of all infected MESHD and recovered patients. Here, we investigated several serological tools, i.e., two immunochromatographic lateral flow assays ( LFA-1 HGNC (Biosynex COVID-19 MESHD BSS) and LFA-2 HGNC ( COVID-19 MESHD 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 MESHD 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 MESHD 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.

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MeSH Disease
HGNC Genes
SARS-CoV-2 Proteins


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