RAPID ACCELERATION OF DIAGNOSTICS (RADX) PROGRAM TECH PROJECT #7697: SARS-COV-2 AG HOME TEST

快速加速诊断 (RADX) 计划技术项目

• 批准号: 10505985
• 负责人: ANDREW WHEELER
• 金额: $ 1176.45万
• 依托单位: MOLOGIC INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-03-31 至 2022-03-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10505985
• 关键词: 2-arachidonylglycerol; 2019-nCoV; Anterior; Biological Assay; Buffers; COVID-19 detection; Clinical; Development; Devices; Housing; Instruction; Performance; RADx; Reagent; Risk; Saliva; Sampling; Testing; Translating; Tube; Virus; Work; design; home test; nasal swab; programs; sample collection; self testing

Mologic is in late state development of a simple and rapid immunochromatographic assay to detect SARS-COV-2 in saliva and anterior nasal swabs. The test is interpreted visually and features an “off board†sample extraction tube that also serves as sample delivery to the test cartridge. The basic instructions are as follows: (1) take sample, and deliver to the extraction tube, (2) Mix (10 seconds or less), (3) cap the tube and deliver sample to the test device, (4) Add chase buffer to the test device (5) Wait 10min and visually interpret results. We propose to modify this design into a more friendly self testing format strictly for saliva. In this design a common “barrel†housing with wick at the end will be employed and extraction reagents dried down into a sample collection “capâ€. In this design, the user would collect saliva into the “cap†to rehydrate the extraction material. Next the barrel test cartridge is added to the cap and the test starts. The proposed project is de-risked by the previous work done by Mologic on assay performance. Current TCID50/mL of live virus has been shown to be at least 7.14x10^3 which should translate to a high level of clinical performance.

Mologic正在开发一种简单快速的免疫层析检测方法，用于检测唾液和鼻前拭子中的SARS-COV-2。该测试在视觉上解释，并设有一个<s:2>€œoff板<e:2>€样品提取管，也可作为样品交付到测试盒。基本操作步骤如下：(1)取样，送入提取管；(2)混合（10秒以内）；(3)盖上管，送入检测装置；(4)在检测装置中加入追踪缓冲液；(5)等待10min，目测结果。我们建议将这个设计修改为一个更友好的自我测试格式，严格针对唾液。在本设计中，将采用常见的<s:2>€œbarrelâ€外壳，末端带有灯芯，并将提取试剂干燥成样品收集器<e:2> œcapâ€。在本设计中，用户将唾液收集到<s:2>€œcapâ€中，对提取材料进行补水。接下来，将枪管测试弹添加到盖上，开始测试。拟议的项目通过Mologic先前在分析性能方面所做的工作来降低风险。目前活病毒的TCID50/mL已被证明至少为7.14x10^3，这应转化为高水平的临床表现。