Diagnostic Performance of a Novel Antigen-Capture Elisa for the Detection of Sars-Cov-2 Publisher Pubmed



Yadegari H¹ ; Mohammadi M¹ ; Maghsood F¹ ; Ghorbani A¹ ; Bahadori T¹ ; Golsazshirazi F¹ ; Zarnani AH¹ ; Salimi V² ; Jedditehrani M³ ; Amiri MM¹ ; Shokri F¹
Source: Analytical Biochemistry Published:2023

Abstract

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. © 2023 Elsevier Inc.