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

Mologic正在开发一种简单快速的免疫层析检测方法，用于检测唾液和前鼻拭子中的SARS-COV-2。该检测通过目视判读，并配有一个“离机”样本提取管，可将样本输送至检测盒。基本说明如下：（1）采集样品，并输送至提取管，（2）混合（10秒或更短时间），（3）盖上试管并将样品输送至试验器械，（4）向试验器械中加入追踪缓冲液（5）等待10分钟并目视判读结果。我们建议将此设计修改为严格针对唾液的更友好的自我测试格式。在这种设计中，将采用末端带有芯的普通“桶”外壳，并且将提取试剂干燥到样本收集“帽”中。在这种设计中，使用者将收集唾液到“帽”中以使提取材料再水合。接下来，将筒测试筒添加到盖上，并开始测试。通过Mologic先前对测定性能所做的工作，降低了拟定项目的风险。目前的活病毒TCID 50/mL已被证明至少为7.14x10^3，这应转化为高水平的临床性能。

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.