• Julien Marlet, Camille Petillon, Emma Ragot, Yazid Abou El Fattah, Antoine Guillon, Marchand Adam Sylvain S Service de Pneumologie et Explorations Fonctionnelles Respiratoires, CHRU de Tours, France., Adrien Lemaignen, Louis Bernard, Guillaume Desoubeaux, Hélène Blasco, Francis Barin, Karl Stefic, and Catherine Gaudy-Graffin.
• Service de Bactériologie-Virologie-Hygiène, CHRU de Tours, France; INSERM U1259, Université de Tours, France. Electronic address: julien.marlet@univ-tours.fr.
• J. Clin. Virol. 2020 Nov 1; 132: 104633.

ObjectivesThe aim of the present study was to evaluate the clinical performance of four SARS-CoV-2 immunoassays and their contribution in routine care for the diagnosis of COVID-19, in order to benefit of robust data before their extensive use.MethodsThe clinical performance of Euroimmun ELISA SARS-CoV-2 IgG, Abbott SARS-CoV-2 IgG, Wantai SARS-CoV-2 Ab ELISA, and DiaPro COVID-19 IgG confirmation were evaluated in the context of both a retrospective and a prospective analysis of COVID-19 patients. The retrospective analysis included plasma samples from 63 COVID-19 patients and 89 control (pre-pandemic) patients. The prospective study included 203 patients who tested either negative (n = 181) or positive (n = 22) by RT-PCR before serology sampling.ResultsThe specificity was 92.1 %, 98.9 %, 100 % and 98.9 % and the sensitivity 14 days after onset of symptoms was 95.6 %, 95.6 %, 97.8 % and 95.6 % for Euroimmun IgG, Abbott IgG, Wantai Ab, and DiaPro IgG confirmation SARS-CoV-2 immunoassays, respectively. The low specificity of Euroimmun IgG (for ratio <5) was not confirmed in routine care setting (98.5 % negative agreement). Serology was complementary to RT-PCR in routine care and lead to identification of false positive (Ct>38, <2 targets detected) and false negative RT-PCR results (>1 month post onset of symptoms).ConclusionsSerology was complementary to RT-PCR for the diagnosis of COVID-19 at least 14 days after onset of symptoms. First line serology testing can be performed with Wantai Ab or Abbott IgG assays, while DiaPro IgG confirmation assay can be used as an efficient confirmation assay.Copyright © 2020 Elsevier B.V. All rights reserved.

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