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

快速加速诊断 (RADX) 技术计划 - 项目

• 批准号: 10505970
• 负责人: DAVID YOO
• 金额: $ 1029.5万
• 依托单位: GENBODY INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-02-02 至 2022-02-01
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10505970
• 关键词: 2019-nCoV; Antigens; Antiviral Agents; COVID-19; COVID-19 detection; Clinical; Devices; Diagnosis; Diagnostic Reagent Kits; Equipment; Eye; Fever; Influenza; Influenza A virus; Influenza B Virus; Koreans; Lateral; Measures; Methods; Oseltamivir; Performance; RADx Tech; SARS-CoV-2 antigen; Symptoms; System; Time; United States Food and Drug Administration; Vaccines; clinical Diagnosis; portability; programs; rapid diagnosis; rapid testing; respiratory

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.

建立了一种在单侧流快速检测（LFRT）系统中同时检测SARS-CoV-2和甲型流感和乙型流感抗原的方法。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。以高热为症状的呼吸道疾病流感与COVID-19相似，临床诊断有很多困难。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。我们开发了SARS-CoV-2抗原快速诊断试剂盒，并对其分析/临床性能进行了评估，获得了食品医药品安全厅的批准，流感A/B抗原诊断试剂盒也获得了许可并商业化。该诊断试剂盒基本上通过肉眼进行诊断，可使用便携式设备（Confiscope G20具有CE但没有FCC）进行准确测定，可应用于使用网络的控制系统。