Diagnostic performance of a novel antigen-capture ELISA for the detection of SARS-CoV-2.
Anal Biochem
; 666: 115079, 2023 04 01.
Article
in En
| MEDLINE
| ID: mdl-36754135
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.Key words
Full text:
1
Database:
MEDLINE
Main subject:
SARS-CoV-2
/
COVID-19
Type of study:
Diagnostic_studies
Limits:
Animals
Language:
En
Journal:
Anal Biochem
Year:
2023
Type:
Article
Affiliation country:
Iran