Clinical performance of four immunoassays for antibodies to SARS-CoV-2, including a prospective analysis for the diagnosis of COVID-19 in a real-life routine care setting

•The sensitivity of evaluated SARS-CoV-2 immunoassays ranged from 95.6% to 97.8%.•The specificity was 92.1% for Euroimmun IgG and ≥ 98.9% for Abbott IgG, Wantai Ab and DiaPro confirmation IgG assays.•A lack of specificity was observed for low positive Euroimmun IgG results (ratio<5) and inconclus...

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Published in:	Journal of clinical virology Vol. 132; p. 104633
Main Authors:	Marlet, Julien, Petillon, Camille, Ragot, Emma, Abou El Fattah, Yazid, Guillon, Antoine, Marchand Adam, Sylvain, Lemaignen, Adrien, Bernard, Louis, Desoubeaux, Guillaume, Blasco, Hélène, Barin, Francis, Stefic, Karl, Gaudy-Graffin, Catherine
Format:	Journal Article
Language:	English
Published:	Netherlands Elsevier B.V 01-11-2020 Elsevier
Subjects:	Adolescent Adult Aged Aged, 80 and over Antibodies, Viral - blood Antibody Child CLIA COVID-19 COVID-19 - diagnosis COVID-19 Testing - methods COVID-19 Testing - standards ELISA Female Human health and pathology Humans Immunoassay Immunoassay - methods Immunoassay - standards Infectious diseases Life Sciences Male Microbiology and Parasitology Middle Aged Prospective Studies Real-Time Polymerase Chain Reaction Reproducibility of Results Retrospective Studies RT-PCR SARS-CoV-2 SARS-CoV-2 - genetics SARS-CoV-2 - immunology Sensitivity and Specificity Serology Virology Young Adult COVID-19 Immunoassay SARS-CoV-2 Antibody RT-PCR Serology CLIA ELISA antibody serology immunoassay
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Summary:	•The sensitivity of evaluated SARS-CoV-2 immunoassays ranged from 95.6% to 97.8%.•The specificity was 92.1% for Euroimmun IgG and ≥ 98.9% for Abbott IgG, Wantai Ab and DiaPro confirmation IgG assays.•A lack of specificity was observed for low positive Euroimmun IgG results (ratio<5) and inconclusive RT-PCR results.•A lack of sensitivity was observed for early serology (<14 days) or late RT-PCR testing (>30 days). The 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. The 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. The 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). Serology 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.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	1386-6532 1873-5967
DOI:	10.1016/j.jcv.2020.104633