An HIV Self-Test

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Project Summary This project proposes to develop and validate an equipment-free point-of-care (POC) device for highly sensitive and quantitative HIV detection. Despite significant progresses made in both HIV detection and treatment, HIV/AIDS remains a global health issue. A simple but highly sensitive and quantitative self-test for monitoring HIV Viral Load (VL) in patients on antiretroviral therapy (ART) will help identify treatment failure earlier to avoid the development of drug resistance, which is key to maintaining the effectiveness and sustainability of ART therapy, especially in resource-poor settings. Additionally, a self-test to detect acute HIV infection will not only improve clinical outcome for these individual patients but also reduce HIV transmission at the population level. Existing nucleic-acid based POC tests for VL monitoring require expensive equipment and centralized laboratories, thus are not feasible for self-testing. In addition, current rapid self-testing assays are based on detecting HIV antibodies, which are not sensitive enough to detect acute HIV infection before the appearance of HIV antibodies. Thus, no POC self-testing assays are currently available for monitoring HIV VL or for the detection of acute HIV infection. We recently developed a self-digitizing (SD) microfluidic chip, which spontaneously partitions an aqueous sample into tens of thousands of nanoliter volumes. Using this SD platform, we have developed and reported the first digital-isothermal-nucleic-acid-amplification assay: digital LAMP (Loop-Mediated Isothermal Amplification). Separately, the first push-button blood self-collection devices are being launched by both Tasso Inc and Seventh Sense Biosystems. Combining these two innovative technologies – Digital Nucleic Acid Assay and Blood Self-Collection – we propose to develop a self-testing HIV device with the following characteristics: 1) Highly sensitive and quantitative for detecting HIV-1 in plasma at VL as low as 50 copies/mL; 2) Easy to use by lay person without special training; 3) Fast, optimally providing results in 20 minutes; 4) Requires no refrigeration and electricity. To validate this self-test, we propose to conduct clinical studies of the self-testing device in Senegal, Africa. When successfully completed, we anticipate our proposed device will make a significant contribution on reaching the ambitious goals laid out by the Joint United Nations Program on HIV/AIDS (UNAIDS) towards ending of the AIDS epidemic.