期刊
JOURNAL OF CLINICAL LABORATORY ANALYSIS
卷 36, 期 7, 页码 -出版社
WILEY
DOI: 10.1002/jcla.24513
关键词
COVID-19; RT-PCR; SARS-CoV-2; Spike protein; time-resolved fluorescence; TRF lateral flow
资金
- RayBiotech innovative research fund
- Guangzhou Innovation Leadership Team [CXLJTD--201602]
- Pearl River S&T Nova Program of Guangzhou [201806010035, 201806010032]
- Guangdong Province Key Technologies R&D Program for Precision Medicine and Stem Cells [2019B020231002, 2019B020227004]
- National Science and Technology Major Project of China [2018ZX10732-401-003-012]
- Industry-University-Research Collaborative Innovation Special Project of Guangzhou [201802030001]
- Guangzhou Basic and Applied Basic Research Project [202002030242]
The study developed a rapid, sensitive, and specific SARS-CoV-2 detection method that can complete sample testing within 15 minutes, showing high sensitivity, specificity, and accuracy in clinical trials.
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). Objectives Our objective was to develop an efficient method of detecting SARS-CoV-2 within 15 min of sample collection. 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. 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. 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.
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