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

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.