AI Article Synopsis
- The COVID-19 pandemic necessitates rapid and accurate detection of the virus for effective management, and an ELISA assay was developed to address this need.
- This assay uses specific mouse monoclonal antibodies for detecting the SARS-CoV-2 nucleocapsid protein and showed a limit of detection at 43.3 pg/ml.
- The assay demonstrated an overall sensitivity of 70.72% and a specificity of 100%, proving effective even with different variants, particularly achieving a high sensitivity of 91.89% for the BA.5 Omicron subvariant in samples with lower viral loads.
Article 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.
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|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9902293 | PMC |
| http://dx.doi.org/10.1016/j.ab.2023.115079 | DOI Listing |
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