Development and evaluation of time‐resolved fluorescent immunochromatographic assay for quantitative detection of SARS‐CoV ‐2 spike antigen

Autor: Buzhou Xu, Hao Tang, Yiming Weng, Valerie Sloane Jones, Shuhong Luo, Chih Yun Cho, Yongping Lin, Jianmin Fang, Xuedong Song, Ruo‐Pan Huang
Rok vydání: 2022
Předmět:
Zdroj: Journal of Clinical Laboratory Analysis. 36
ISSN: 1098-2825
0887-8013
Popis: 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).Our objective was to develop an efficient method of detecting SARS-CoV-2 within 15 min of sample collection.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.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 at80% sensitivity,84% specificity, and 82% accuracy for detection of the S1-RBD antigen.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.
Databáze: OpenAIRE
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