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

Autor: Yadegari H; Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran., Mohammadi M; Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran., Maghsood F; Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran., Ghorbani A; Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran., Bahadori T; Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran., Golsaz-Shirazi F; Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran., Zarnani AH; Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran., Salimi V; Department of Virology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran., Jeddi-Tehrani M; Monoclonal Antibody Research Center, Avicenna Research Institute, Academic Center for Education, Culture and Research (ACECR), Tehran, Iran., Amiri MM; Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: m_amiri@tums.ac.ir., Shokri F; Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: fshokri@tums.ac.ir.
Jazyk: angličtina
Zdroj: Analytical biochemistry [Anal Biochem] 2023 Apr 01; Vol. 666, pp. 115079. Date of Electronic Publication: 2023 Feb 07.
DOI: 10.1016/j.ab.2023.115079
Abstrakt: 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.
Competing Interests: Declaration of competing interest The authors declare no conflict of interest.
(Copyright © 2023 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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