1. Diagnostic performance of a novel antigen-capture ELISA for the detection of SARS-CoV-2.
- Author
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Yadegari, Hamidreza, Mohammadi, Mehdi, Maghsood, Faezeh, Ghorbani, Ahmad, Bahadori, Tannaz, Golsaz-Shirazi, Forough, Zarnani, Amir-Hassan, Salimi, Vahid, Jeddi-Tehrani, Mahmood, Amiri, Mohammad Mehdi, and Shokri, Fazel
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SARS-CoV-2 Delta variant , *COVID-19 , *SARS-CoV-2 Omicron variant , *VIRAL antigens , *SARS-CoV-2 , *PLANT viruses - Abstract
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. 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. 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. 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. [Display omitted] • Antigen-based serological assays are efficient methods for SARS-CoV-2 screening. • The viral nucleoprotein is the best target due to protein abundance and stability. • We designed a sandwich ELISA using novel nucleoprotein specific MAbs. • Antigen titer correlates inversely to cycle threshold values in clinical samples. • This assay is sensitive and highly specific irrespective of the viral variants. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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