RAPID RT-LAMP ASSAY FOR SELF-MONITORING OF ACUTE OR REBOUND HIV-1 INFECTION USING FINGER-PRICK WHOLE BLOOD SAMPLE AND RNA EXTRACTION

This NIH SBIR Phase I contract proposal aims to develop a cost-effective and rapid molecular test for selftestingacute HIV infection or its rebound. The goal is to maintain diagnostic accuracy of HIV self-test(HIVST) while enabling minimal training for operation, expanding access to HIV diagnostics. Because asignificant proportion of the individuals are unaware of their infection status, expanding testing capabilitieshas a high potential to reach previously untested high-risk populations and connect them to medical care.Current molecular devices are expensive and require specialized training while existing self-testingtechnologies detect antibodies weeks after infection. AI Biosciences proposes a low-cost and simpleextraction step using only finger-picked whole blood, followed by colorimetric isothermal amplification anddetection of the viral RNA. In Phase I, the simple and yet highly effective RNA extraction step will be coupledwith the LAMP amplification manually. It will be integrated as a single device in Phase II. This palm-sizedsystem does not use high-cost components, thus making it suitable for decentralized settings including theself-testing market. This test uses simple instructions and requires minimal training and hands-on time.Partnering with public health expert and Gener8 Product Development, we aim to create a 40-minutesample-to-answer test.