RayBiotech, Guangzhou, Guangzhou, China.
RayBiotech Life, Peachtree Corners, Georgia, USA.
J Clin Lab Anal. 2022 Jul;36(7):e24513. doi: 10.1002/jcla.24513. Epub 2022 Jun 12.
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 at >80% 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.
由严重急性呼吸系统综合征冠状病毒 2（SARS-CoV-2）引起的 COVID-19 在全球范围内的传播，需要有效的、敏感的诊断方法来识别感染者。我们报告了一种快速 15 分钟时间分辨荧光（TRF）侧向流动免疫层析测定法的开发，用于定量检测 SARS-CoV-2 刺突蛋白受体结合域（S1-RBD）。
我们的目的是开发一种在样本采集后 15 分钟内检测 SARS-CoV-2 的有效方法。
我们构建并评估了一种便携式、一次性的侧向流动设备，该设备可以直接检测鼻咽拭子样本中的 S1-RBD 蛋白。该设备在存在 S1-RBD 时会发出荧光信号，可被自动 TRF 仪器捕获。
TRF 侧向流动测定信号在 0 至 20ng/ml 范围内呈线性，具有较高的准确性和重现性。当用临床鼻咽拭子进行评估时，该测定法的检测 S1-RBD 抗原的灵敏度>80%，特异性>84%，准确性>82%。
新的 S1-RBD 抗原检测是一种快速（15 分钟）、灵敏和特异的检测方法，需要的样本制备最少。至关重要的是，该测定法与鼻咽拭子样本中的基于 PCR 的方法密切相关，表明检测到的 S1-RBD 抗原水平与 SARS-CoV-2 病毒载量相关。因此，新的 S1-RBD TRF 侧向流动试验具有在即时护理环境中应用的潜力。
