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

莫洛奇公司正在开发一种简单快速的免疫层析法，以检测唾液和前鼻拭子中的SARS-COV-2。该测试在视觉上进行了解释，并配备了一个非机载œ样品提取管，该管还可以将样品输送到测试盒。基本操作步骤如下：(1)取样品，送至萃取管，(2)混合(10秒或更短)，(3)盖上试管并将样品送至测试装置，(4)在测试装置中加入追逐缓冲液(5)等待10分钟，并目测结果。我们建议将此设计修改为一种更友好的自检格式，严格针对唾液。在这个设计中，将使用一个普通的、末端有灯芯的欧式œ桶形住房，并将提取试剂干燥成一个欧式œ帽的样本集合。在这种设计中，使用者将唾液收集到œ帽中，以补充提取材料的水分。接下来，将枪管测试盒添加到盖子中，然后开始测试。莫洛奇之前在分析性能方面所做的工作降低了拟议的项目的风险。目前每毫升活病毒的TCID50已被证明至少为7.14×10^3，这应该会转化为高水平的临床表现。

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.