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Diagnostic performance of a novel antigen-capture ELISA for the detection of SARS-CoV-2

BACKGROUND AND AIMS: The coronavirus disease 2019 (COVID-19) pandemic is a serious health problem worldwide. Early virus detection is essential for disease control and management. Viral antigen detection by ELISA is a cost-effective, rapid, and accurate antigen diagnostic assay which could facilitat...

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Autores principales: Yadegari, Hamidreza, Mohammadi, Mehdi, Maghsood, Faezeh, Ghorbani, Ahmad, Bahadori, Tannaz, Golsaz-Shirazi, Forough, Zarnani, Amir-Hassan, Salimi, Vahid, Jeddi-Tehrani, Mahmood, Amiri, Mohammad Mehdi, Shokri, Fazel
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier Inc. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9902293/
https://www.ncbi.nlm.nih.gov/pubmed/36754135
http://dx.doi.org/10.1016/j.ab.2023.115079
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author Yadegari, Hamidreza
Mohammadi, Mehdi
Maghsood, Faezeh
Ghorbani, Ahmad
Bahadori, Tannaz
Golsaz-Shirazi, Forough
Zarnani, Amir-Hassan
Salimi, Vahid
Jeddi-Tehrani, Mahmood
Amiri, Mohammad Mehdi
Shokri, Fazel
author_facet Yadegari, Hamidreza
Mohammadi, Mehdi
Maghsood, Faezeh
Ghorbani, Ahmad
Bahadori, Tannaz
Golsaz-Shirazi, Forough
Zarnani, Amir-Hassan
Salimi, Vahid
Jeddi-Tehrani, Mahmood
Amiri, Mohammad Mehdi
Shokri, Fazel
author_sort Yadegari, Hamidreza
collection PubMed
description BACKGROUND AND AIMS: The coronavirus disease 2019 (COVID-19) pandemic is a serious health problem worldwide. Early virus detection is essential for disease control and management. Viral antigen detection by ELISA is a cost-effective, rapid, and accurate antigen diagnostic assay which could facilitate early viral detection. METHOD: An antigen-capture sandwich ELISA was developed using novel nucleocapsid (NP)-specific mouse monoclonal antibodies (MAbs). The clinical performance of the assay was assessed using 403 positive and 150 negative respiratory samples collected during different SARS-CoV-2 variants outbreaks in Iran. RESULTS: The limit of detection of our ELISA assay was found to be 43.3 pg/ml for recombinant NP. The overall sensitivity and specificity of this assay were 70.72% (95% CI: 66.01–75.12) and 100% (95% CI: 97.57–100), respectively, regardless of Ct values and SARS-CoV-2 variants. There was no significant difference in our assay sensitivity for the detection of Omicron subvariants compared to Delta variant. Assay sensitivity for the BA.5 Omicron subvariant was calculated as 91.89% (95% CI: 85.17–96.23) for samples with Ct values < 25 and 82.70% (95% CI: 75.19–88.71) for samples with Ct values < 30. CONCLUSION: Our newly developed ELISA method is reasonably sensitive and highly specific for detection of SARS-CoV-2 regardless of the variants and subvariants of the virus.
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spelling pubmed-99022932023-02-07 Diagnostic performance of a novel antigen-capture ELISA for the detection of SARS-CoV-2 Yadegari, Hamidreza Mohammadi, Mehdi Maghsood, Faezeh Ghorbani, Ahmad Bahadori, Tannaz Golsaz-Shirazi, Forough Zarnani, Amir-Hassan Salimi, Vahid Jeddi-Tehrani, Mahmood Amiri, Mohammad Mehdi Shokri, Fazel Anal Biochem Article BACKGROUND AND AIMS: The coronavirus disease 2019 (COVID-19) pandemic is a serious health problem worldwide. Early virus detection is essential for disease control and management. Viral antigen detection by ELISA is a cost-effective, rapid, and accurate antigen diagnostic assay which could facilitate early viral detection. METHOD: An antigen-capture sandwich ELISA was developed using novel nucleocapsid (NP)-specific mouse monoclonal antibodies (MAbs). The clinical performance of the assay was assessed using 403 positive and 150 negative respiratory samples collected during different SARS-CoV-2 variants outbreaks in Iran. RESULTS: The limit of detection of our ELISA assay was found to be 43.3 pg/ml for recombinant NP. The overall sensitivity and specificity of this assay were 70.72% (95% CI: 66.01–75.12) and 100% (95% CI: 97.57–100), respectively, regardless of Ct values and SARS-CoV-2 variants. There was no significant difference in our assay sensitivity for the detection of Omicron subvariants compared to Delta variant. Assay sensitivity for the BA.5 Omicron subvariant was calculated as 91.89% (95% CI: 85.17–96.23) for samples with Ct values < 25 and 82.70% (95% CI: 75.19–88.71) for samples with Ct values < 30. CONCLUSION: Our newly developed ELISA method is reasonably sensitive and highly specific for detection of SARS-CoV-2 regardless of the variants and subvariants of the virus. Elsevier Inc. 2023-04-01 2023-02-07 /pmc/articles/PMC9902293/ /pubmed/36754135 http://dx.doi.org/10.1016/j.ab.2023.115079 Text en © 2023 Elsevier Inc. All rights reserved. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.
spellingShingle Article
Yadegari, Hamidreza
Mohammadi, Mehdi
Maghsood, Faezeh
Ghorbani, Ahmad
Bahadori, Tannaz
Golsaz-Shirazi, Forough
Zarnani, Amir-Hassan
Salimi, Vahid
Jeddi-Tehrani, Mahmood
Amiri, Mohammad Mehdi
Shokri, Fazel
Diagnostic performance of a novel antigen-capture ELISA for the detection of SARS-CoV-2
title Diagnostic performance of a novel antigen-capture ELISA for the detection of SARS-CoV-2
title_full Diagnostic performance of a novel antigen-capture ELISA for the detection of SARS-CoV-2
title_fullStr Diagnostic performance of a novel antigen-capture ELISA for the detection of SARS-CoV-2
title_full_unstemmed Diagnostic performance of a novel antigen-capture ELISA for the detection of SARS-CoV-2
title_short Diagnostic performance of a novel antigen-capture ELISA for the detection of SARS-CoV-2
title_sort diagnostic performance of a novel antigen-capture elisa for the detection of sars-cov-2
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9902293/
https://www.ncbi.nlm.nih.gov/pubmed/36754135
http://dx.doi.org/10.1016/j.ab.2023.115079
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