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

• Published in: Analytical biochemistry 2023-04, Vol.666, p.115079-115079, Article 115079
• Main Authors: 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
• Format: Article
• Language: English
• Subjects: Animals; Antibodies, Monoclonal; Antibodies, Viral; COVID-19; COVID-19 Testing; Enzyme-Linked Immunosorbent Assay - methods; Mice; Monoclonal antibody; Nucleocapsid; Sandwich ELISA; SARS-CoV-2; Sensitivity and Specificity
• ISSN: 0003-2697; 1096-0309
• DOI: 10.1016/j.ab.2023.115079

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