MULTIPLEXED NUCLEIC ACID SELF-TEST FOR REPRODUCIBLE AND SENSITIVE HIV DETECTION

We propose developing a droplet digital nucleic acid test for home use, empowering individuals to detectearly HIV infection and monitor viral suppression in chronic treatment. This multiplexed test will address keychallenges, including achieving high sensitivity and specificity while minimizing false positives due tofrequent testing and the variability of home environments. In Phase I, we will establish feasibility and proofof-concept by defining a Target Product Profile (TPP) for diagnostic performance. We will develop a dropletdigital LAMP (ddLAMP) method to detect and quantify HIV in blood, synthesizing the necessary primers,probes, and spike-in nucleic acids. These methods will be validated, and Standard Operating Procedures(SOPs) created. We will evaluate the assay’s sensitivity, specificity, and detection limits, followed by a proofof-concept study using samples from individuals with known HIV status. The final product aims to achieveover 99% sensitivity and specificity, enabling accurate detection of HIV during early infection, in individualson antiretroviral therapy, and in those with vaccine-induced seroreactivity, through a self-test.