RAPID ACCELERATION OF DIAGNOSTICS (RADX) TECH PROGRAM - PROJECT #6658

建立了一种既能同时检测SARS-CoV-2，又能同时检测甲型和乙型流感病毒抗原的单侧向流动快速检测系统。该试剂盒是一种可以同时检测SARS-CoV-2抗原和流感抗原的单一设备。由于流感合并呼吸道疾病并伴有高烧症状与新冠肺炎相似，因此与临床诊断区分有很多困难。流感可以用达菲等抗病毒药物治疗，也有疫苗等防御措施，所以治疗方法不同。我们已经开发并评估了SARS-CoV-2抗原快速诊断试剂盒的分析/临床性能，获得了韩国食品和药物管理局的批准，流感A/B抗原诊断试剂盒也已获得许可并商业化。该诊断试剂盒基本上是通过肉眼诊断的，便携式设备(Conficope G20有CE，但没有FCC)可以用于准确的确定，可以应用于使用网络的控制系统。

A method was developed to detect not only SARS-CoV-2, but also influenza A and Influenza B anigen at the same time in a single lateral flow rapid testing (LFRT) system. The kit is a single device that can detect SARS-CoV-2 antigen and influenza antigen simultaneously.  Since Influenza with respiratory illness with symptoms of high fever is similar to COVID-19, there are many difficulties to distinguish it from clinical diagnosis. Influenza can be treated with antiviral drugs such as Tamiflu, and there are also defense measures such as vaccines, so the treatment method is different. We have developed and evaluated an analytical/clinical performance for rapid diagnosis kit of SARS-CoV-2 antigen, obtained approval from the Korean Food and Drug Administration, and diagnostic Kits for influenza A/B antigen have also been licensed and commercialized. This diagnostic kit is basically diagnosed through the naked eye, and a portable equipment (Confiscope G20 has CE but no FCC) can be used for accurate determination which can be applied to control systems using a network.