Performance of nucleocapsid and spike-based SARS-CoV-2 serologic assays.

There is an urgent need for an accurate antibody test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We have developed 3 ELISA methods, trimer spike IgA, trimer spike IgG, and nucleocapsid IgG, for detecting anti-SARS-CoV-2 antibodies. We evaluated their performance along with fou...

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Autores principales:	Zahra Rikhtegaran Tehrani, Saman Saadat, Ebtehal Saleh, Xin Ouyang, Niel Constantine, Anthony L DeVico, Anthony D Harris, George K Lewis, Shyam Kottilil, Mohammad M Sajadi
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2020
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/f5201487a4cd453aab1a89885fdc7429
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spelling	oai:doaj.org-article:f5201487a4cd453aab1a89885fdc74292021-12-02T20:11:28ZPerformance of nucleocapsid and spike-based SARS-CoV-2 serologic assays.1932-620310.1371/journal.pone.0237828https://doaj.org/article/f5201487a4cd453aab1a89885fdc74292020-01-01T00:00:00Zhttps://doi.org/10.1371/journal.pone.0237828https://doaj.org/toc/1932-6203There is an urgent need for an accurate antibody test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We have developed 3 ELISA methods, trimer spike IgA, trimer spike IgG, and nucleocapsid IgG, for detecting anti-SARS-CoV-2 antibodies. We evaluated their performance along with four commercial ELISAs, EDI™ Novel Coronavirus COVID-19 ELISA IgG and IgM, Euroimmun Anti-SARS-CoV-2 ELISA IgG and IgA, and one lateral flow assay, DPP® COVID-19 IgM/IgG System (Chembio). Both sensitivity and specificity were evaluated and the probable causes of false-positive reactions were determined. The assays were evaluated using 300 pre-epidemic samples and 100 PCR-confirmed COVID-19 samples. The sensitivities and specificities of the assays were as follows: 90%/100% (in-house trimer spike IgA), 90%/99.3% (in-house trimer spike IgG), 89%/98.3% (in-house nucleocapsid IgG), 73.7%/100% (EDI nucleocapsid IgM), 84.5%/95.1% (EDI nucleocapsid IgG), 95%/93.7% (Euroimmun S1 IgA), 82.8%/99.7% (Euroimmun S1 IgG), 82.0%/91.7% (Chembio nucleocapsid IgM), 92%/93.3% (Chembio nucleocapsid IgG). The presumed causes of false positive results from pre-epidemic samples in commercial and in-house assays were mixed. In some cases, assays lacked reproducibility. In other cases, reactivity was abrogated by competitive inhibition (spiking the sample with the same antigen that was used for coating ELISAs prior to performing the assay), suggesting positive reaction could be attributed to the presence of antibodies against these antigens. In other cases, reactivity was consistently detected but not abrogated by the spiking, suggesting positive reaction was not attributed to the presence of antibodies against these antigens. Overall, there was wide variability in assay performance using our samples, with in-house tests exhibiting the highest combined sensitivity and specificity. The causes of "false positivity" in pre-epidemic samples may be due to plasma antibodies apparently reacting with the corresponding antigen, or spurious reactivity may be directed against non-specific components in the assay system. Identification of these targets will be essential to improving assay performance.Zahra Rikhtegaran TehraniSaman SaadatEbtehal SalehXin OuyangNiel ConstantineAnthony L DeVicoAnthony D HarrisGeorge K LewisShyam KottililMohammad M SajadiPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 15, Iss 11, p e0237828 (2020)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Zahra Rikhtegaran Tehrani Saman Saadat Ebtehal Saleh Xin Ouyang Niel Constantine Anthony L DeVico Anthony D Harris George K Lewis Shyam Kottilil Mohammad M Sajadi Performance of nucleocapsid and spike-based SARS-CoV-2 serologic assays.
description	There is an urgent need for an accurate antibody test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We have developed 3 ELISA methods, trimer spike IgA, trimer spike IgG, and nucleocapsid IgG, for detecting anti-SARS-CoV-2 antibodies. We evaluated their performance along with four commercial ELISAs, EDI™ Novel Coronavirus COVID-19 ELISA IgG and IgM, Euroimmun Anti-SARS-CoV-2 ELISA IgG and IgA, and one lateral flow assay, DPP® COVID-19 IgM/IgG System (Chembio). Both sensitivity and specificity were evaluated and the probable causes of false-positive reactions were determined. The assays were evaluated using 300 pre-epidemic samples and 100 PCR-confirmed COVID-19 samples. The sensitivities and specificities of the assays were as follows: 90%/100% (in-house trimer spike IgA), 90%/99.3% (in-house trimer spike IgG), 89%/98.3% (in-house nucleocapsid IgG), 73.7%/100% (EDI nucleocapsid IgM), 84.5%/95.1% (EDI nucleocapsid IgG), 95%/93.7% (Euroimmun S1 IgA), 82.8%/99.7% (Euroimmun S1 IgG), 82.0%/91.7% (Chembio nucleocapsid IgM), 92%/93.3% (Chembio nucleocapsid IgG). The presumed causes of false positive results from pre-epidemic samples in commercial and in-house assays were mixed. In some cases, assays lacked reproducibility. In other cases, reactivity was abrogated by competitive inhibition (spiking the sample with the same antigen that was used for coating ELISAs prior to performing the assay), suggesting positive reaction could be attributed to the presence of antibodies against these antigens. In other cases, reactivity was consistently detected but not abrogated by the spiking, suggesting positive reaction was not attributed to the presence of antibodies against these antigens. Overall, there was wide variability in assay performance using our samples, with in-house tests exhibiting the highest combined sensitivity and specificity. The causes of "false positivity" in pre-epidemic samples may be due to plasma antibodies apparently reacting with the corresponding antigen, or spurious reactivity may be directed against non-specific components in the assay system. Identification of these targets will be essential to improving assay performance.
format	article
author	Zahra Rikhtegaran Tehrani Saman Saadat Ebtehal Saleh Xin Ouyang Niel Constantine Anthony L DeVico Anthony D Harris George K Lewis Shyam Kottilil Mohammad M Sajadi
author_facet	Zahra Rikhtegaran Tehrani Saman Saadat Ebtehal Saleh Xin Ouyang Niel Constantine Anthony L DeVico Anthony D Harris George K Lewis Shyam Kottilil Mohammad M Sajadi
author_sort	Zahra Rikhtegaran Tehrani
title	Performance of nucleocapsid and spike-based SARS-CoV-2 serologic assays.
title_short	Performance of nucleocapsid and spike-based SARS-CoV-2 serologic assays.
title_full	Performance of nucleocapsid and spike-based SARS-CoV-2 serologic assays.
title_fullStr	Performance of nucleocapsid and spike-based SARS-CoV-2 serologic assays.
title_full_unstemmed	Performance of nucleocapsid and spike-based SARS-CoV-2 serologic assays.
title_sort	performance of nucleocapsid and spike-based sars-cov-2 serologic assays.
publisher	Public Library of Science (PLoS)
publishDate	2020
url	https://doaj.org/article/f5201487a4cd453aab1a89885fdc7429
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Performance of nucleocapsid and spike-based SARS-CoV-2 serologic assays.

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