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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...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2020
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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. |
format | Online Article Text |
id | pubmed-7767212 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
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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