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Development and evaluation of time-resolved fluorescent immunochromatographic assay for quantitative detection of SARS-CoV-2 spike antigen.
- Source :
-
Journal of clinical laboratory analysis [J Clin Lab Anal] 2022 Jul; Vol. 36 (7), pp. e24513. Date of Electronic Publication: 2022 Jun 12. - Publication Year :
- 2022
-
Abstract
- Background: The spread of COVID-19 worldwide caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has necessitated efficient, sensitive diagnostic methods to identify infected people. We report on the development of a rapid 15-minute time-resolved fluorescent (TRF) lateral flow immunochromatographic assay for the quantitative detection of the SARS-CoV-2 spike protein receptor-binding domain (S1-RBD).<br />Objectives: Our objective was to develop an efficient method of detecting SARS-CoV-2 within 15 min of sample collection.<br />Methods: We constructed and evaluated a portable, disposable lateral flow device, which detected the S1-RBD protein directly in nasopharyngeal swab samples. The device emits a fluorescent signal in the presence of S1-RBD, which can be captured by an automated TRF instrument.<br />Results: The TRF lateral flow assay signal was linear from 0 to 20 ng/ml and demonstrated high accuracy and reproducibility. When evaluated with clinical nasopharyngeal swabs, the assay was performed at >80% sensitivity, >84% specificity, and > 82% accuracy for detection of the S1-RBD antigen.<br />Conclusion: The new S1-RBD antigen test is a rapid (15 min), sensitive, and specific assay that requires minimal sample preparation. Critically, the assay correlated closely with PCR-based methodology in nasopharyngeal swab samples, showing that the detected S1-RBD antigen levels correlate with SARS-CoV-2 virus load. Therefore, the new TRF lateral flow test for S1-RBD has potential application in point-of-care settings.<br /> (© 2022 The Authors. Journal of Clinical Laboratory Analysis published by Wiley Periodicals LLC.)
Details
- Language :
- English
- ISSN :
- 1098-2825
- Volume :
- 36
- Issue :
- 7
- Database :
- MEDLINE
- Journal :
- Journal of clinical laboratory analysis
- Publication Type :
- Academic Journal
- Accession number :
- 35692032
- Full Text :
- https://doi.org/10.1002/jcla.24513