tetano
Editor, Senior Moderator
Anal Biochem
. 2023 Feb 6;115079.
doi: 10.1016/j.ab.2023.115079. Online ahead of print.
Diagnostic performance of a novel antigen-capture ELISA for the detection of SARS-CoV-2
Hamidreza Yadegari[SUP] 1 [/SUP], Mehdi Mohammadi[SUP] 1 [/SUP], Faezeh Maghsood[SUP] 1 [/SUP], Ahmad Ghorbani[SUP] 1 [/SUP], Tannaz Bahadori[SUP] 1 [/SUP], Forough Golsaz-Shirazi[SUP] 1 [/SUP], Amir-Hassan Zarnani[SUP] 1 [/SUP], Vahid Salimi[SUP] 2 [/SUP], Mahmood Jeddi Tehrani[SUP] 3 [/SUP], Mohammad Mehdi Amiri[SUP] 4 [/SUP], Fazel Shokri[SUP] 5 [/SUP]
Affiliations
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.
Keywords: COVID-19; Monoclonal antibody; Nucleocapsid; SARS-CoV-2; Sandwich ELISA.
. 2023 Feb 6;115079.
doi: 10.1016/j.ab.2023.115079. Online ahead of print.
Diagnostic performance of a novel antigen-capture ELISA for the detection of SARS-CoV-2
Hamidreza Yadegari[SUP] 1 [/SUP], Mehdi Mohammadi[SUP] 1 [/SUP], Faezeh Maghsood[SUP] 1 [/SUP], Ahmad Ghorbani[SUP] 1 [/SUP], Tannaz Bahadori[SUP] 1 [/SUP], Forough Golsaz-Shirazi[SUP] 1 [/SUP], Amir-Hassan Zarnani[SUP] 1 [/SUP], Vahid Salimi[SUP] 2 [/SUP], Mahmood Jeddi Tehrani[SUP] 3 [/SUP], Mohammad Mehdi Amiri[SUP] 4 [/SUP], Fazel Shokri[SUP] 5 [/SUP]
Affiliations
- PMID: 36754135
- DOI: 10.1016/j.ab.2023.115079
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.
Keywords: COVID-19; Monoclonal antibody; Nucleocapsid; SARS-CoV-2; Sandwich ELISA.