Mokkapati Vijaya K, Sam Niedbala R, Kardos Keith, Perez Ronelito J, Guo Ming, Tanke Hans J, Corstjens Paul L A M
OraSure Technologies Inc., Bethlehem, Pennsylvania, USA.
Ann N Y Acad Sci. 2007 Mar;1098:476-85. doi: 10.1196/annals.1384.021.
A prototype rapid antigen test for the on-site detection of respiratory syncytial virus (RSV) infection was developed and evaluated. The platform uses instrumented assay analysis, eliminating potential operator bias in the interpretation of the test result that may occur with visually interpreted rapid antigen assays. The device was tested as the first point-of-care (POC) infectious disease application of novel reporter up-converting phosphor technology (UPT) using a specifically designed portable UPT reader (UPlink). Assays were performed by mixing nasopharyngeal specimen with RSV-specific UPT reporter particles and addition of the mixture to a disposable cassette containing a lateral flow (LF) strip with RSV capture antibodies. UPT reporters bound on the specific capture zone were analyzed with the UPlink reader. Reproducibility testing of the UPlink-RSV (UPR) test by naïve users confirmed the potential of UPlink for POC applications where testing is not always performed by highly trained medical staff. The performance of UPR was further evaluated with clinical nasopharyngeal specimens. A prospective study at an independent test site demonstrated clinical parameters of 90% sensitivity and 98.3% specificity with an overall correlation of 96.2% as compared to viral culture with RT-PCR verification. These results are in agreement with in-house retrospective studies and results obtained with other available commercial rapid antigen assays.
开发并评估了一种用于现场检测呼吸道合胞病毒（RSV）感染的快速抗原检测原型。该平台采用仪器化分析，消除了视觉判读快速抗原检测可能出现的检测结果判读中潜在的操作人员偏差。该设备作为新型报告上转换磷光技术（UPT）的首个即时检测（POC）传染病应用，使用专门设计的便携式UPT读数器（UPlink）进行测试。检测方法是将鼻咽标本与RSV特异性UPT报告颗粒混合，然后将混合物加入到一个包含带有RSV捕获抗体的侧向流动（LF）条的一次性试剂盒中。用UPlink读数器分析在特定捕获区结合的UPT报告物。新手用户对UPlink-RSV（UPR）检测进行的重复性测试证实了UPlink在即时检测应用中的潜力，即时检测并非总是由训练有素的医务人员进行。使用临床鼻咽标本进一步评估了UPR的性能。在一个独立测试地点进行的一项前瞻性研究表明，与经RT-PCR验证的病毒培养相比，临床参数为敏感性90%、特异性98.3%，总体相关性为96.2%。这些结果与内部回顾性研究以及其他现有商业快速抗原检测结果一致。
