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Performance of Commercially Available Rapid Serological Assays for the Detection of SARS-CoV-2 Antibodies

The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), continues to spread globally. Although several rapid commercial serological assays have been developed, little is known about their performance and accuracy in detecting SARS...

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Autores principales: Hashem, Anwar M., Alhabbab, Rowa Y., Algaissi, Abdullah, Alfaleh, Mohamed A., Hala, Sharif, Abujamel, Turki S., ElAssouli, M-Zaki, AL-Somali, Afrah A., Alofi, Fadwa S., Khogeer, Asim A., Alkayyal, Almohanad A., Mahmoud, Ahmad Bakur, Almontashiri, Naif A. M., Pain, Arnab
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7767212/
https://www.ncbi.nlm.nih.gov/pubmed/33352788
http://dx.doi.org/10.3390/pathogens9121067
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author Hashem, Anwar M.
Alhabbab, Rowa Y.
Algaissi, Abdullah
Alfaleh, Mohamed A.
Hala, Sharif
Abujamel, Turki S.
ElAssouli, M-Zaki
AL-Somali, Afrah A.
Alofi, Fadwa S.
Khogeer, Asim A.
Alkayyal, Almohanad A.
Mahmoud, Ahmad Bakur
Almontashiri, Naif A. M.
Pain, Arnab
author_facet Hashem, Anwar M.
Alhabbab, Rowa Y.
Algaissi, Abdullah
Alfaleh, Mohamed A.
Hala, Sharif
Abujamel, Turki S.
ElAssouli, M-Zaki
AL-Somali, Afrah A.
Alofi, Fadwa S.
Khogeer, Asim A.
Alkayyal, Almohanad A.
Mahmoud, Ahmad Bakur
Almontashiri, Naif A. M.
Pain, Arnab
author_sort Hashem, Anwar M.
collection PubMed
description The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), continues to spread globally. Although several rapid commercial serological assays have been developed, little is known about their performance and accuracy in detecting SARS-CoV-2-specific antibodies in COVID-19 patient samples. Here, we have evaluated the performance of seven commercially available rapid lateral flow immunoassays (LFIA) obtained from different manufacturers, and compared them to in-house developed and validated ELISA assays for the detection of SARS-CoV-2-specific IgM and IgG antibodies in RT-PCR-confirmed COVID-19 patients. While all evaluated LFIA assays showed high specificity, our data showed a significant variation in sensitivity of these assays, which ranged from 0% to 54% for samples collected early during infection (3–7 days post symptoms onset) and from 54% to 88% for samples collected at later time points during infection (8–27 days post symptoms onset). Therefore, we recommend prior evaluation and validation of these assays before being routinely used to detect IgM and IgG in COVID-19 patients. Moreover, our findings suggest the use of LFIA assays in combination with other standard methods, and not as an alternative.
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spelling pubmed-77672122020-12-28 Performance of Commercially Available Rapid Serological Assays for the Detection of SARS-CoV-2 Antibodies Hashem, Anwar M. Alhabbab, Rowa Y. Algaissi, Abdullah Alfaleh, Mohamed A. Hala, Sharif Abujamel, Turki S. ElAssouli, M-Zaki AL-Somali, Afrah A. Alofi, Fadwa S. Khogeer, Asim A. Alkayyal, Almohanad A. Mahmoud, Ahmad Bakur Almontashiri, Naif A. M. Pain, Arnab Pathogens Brief Report The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), continues to spread globally. Although several rapid commercial serological assays have been developed, little is known about their performance and accuracy in detecting SARS-CoV-2-specific antibodies in COVID-19 patient samples. Here, we have evaluated the performance of seven commercially available rapid lateral flow immunoassays (LFIA) obtained from different manufacturers, and compared them to in-house developed and validated ELISA assays for the detection of SARS-CoV-2-specific IgM and IgG antibodies in RT-PCR-confirmed COVID-19 patients. While all evaluated LFIA assays showed high specificity, our data showed a significant variation in sensitivity of these assays, which ranged from 0% to 54% for samples collected early during infection (3–7 days post symptoms onset) and from 54% to 88% for samples collected at later time points during infection (8–27 days post symptoms onset). Therefore, we recommend prior evaluation and validation of these assays before being routinely used to detect IgM and IgG in COVID-19 patients. Moreover, our findings suggest the use of LFIA assays in combination with other standard methods, and not as an alternative. MDPI 2020-12-19 /pmc/articles/PMC7767212/ /pubmed/33352788 http://dx.doi.org/10.3390/pathogens9121067 Text en © 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Brief Report
Hashem, Anwar M.
Alhabbab, Rowa Y.
Algaissi, Abdullah
Alfaleh, Mohamed A.
Hala, Sharif
Abujamel, Turki S.
ElAssouli, M-Zaki
AL-Somali, Afrah A.
Alofi, Fadwa S.
Khogeer, Asim A.
Alkayyal, Almohanad A.
Mahmoud, Ahmad Bakur
Almontashiri, Naif A. M.
Pain, Arnab
Performance of Commercially Available Rapid Serological Assays for the Detection of SARS-CoV-2 Antibodies
title Performance of Commercially Available Rapid Serological Assays for the Detection of SARS-CoV-2 Antibodies
title_full Performance of Commercially Available Rapid Serological Assays for the Detection of SARS-CoV-2 Antibodies
title_fullStr Performance of Commercially Available Rapid Serological Assays for the Detection of SARS-CoV-2 Antibodies
title_full_unstemmed Performance of Commercially Available Rapid Serological Assays for the Detection of SARS-CoV-2 Antibodies
title_short Performance of Commercially Available Rapid Serological Assays for the Detection of SARS-CoV-2 Antibodies
title_sort performance of commercially available rapid serological assays for the detection of sars-cov-2 antibodies
topic Brief Report
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7767212/
https://www.ncbi.nlm.nih.gov/pubmed/33352788
http://dx.doi.org/10.3390/pathogens9121067
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