The Problem: Approximately 38 million people worldwide are infected with HIV, with nearly 40% of them being unaware of their HIV status.4-8 A similar phenomenon has been observed in the United States, particularly in the southern parts of the country. Cases are becoming more common among adolescents and young adults (AYAs), and although routine HIV testing is now recommended and more widely available, yet HIV testing is sparce among them. Therefore, timely identification is needed to enhance disease outcomes and minimize HIV transmission, and our accurate self-testing format offers a viable solution to expand diagnosis. As a point of care test, the ability of the test to provide accurate antigen and antibody test results in less than 30 minutes will allow care providers to detect HIV infection and engage the patient(s) in care immediately. Individuals participating in either the pre-exposure prophylaxis (PrEP) or in the mother to child prevention transmission programs (MTC) will also benefit from such a test. Approach: To address this problem, IgE ImmunoDiagnostics, Inc. proposes adapting their successful IgE-HIV ELISA (98/95% sensitivity and specificity) to a rapid test format. The team will develop a 5th generation Ag/Ab combo system with the help of a select group of Bioamerica Inc research and development leaders. The team expects to surpass their prior test, maximizing overall sensitivity and specificity, thus outperforming existing commercially available rapid tests, and have near equivalence to the more complicated PCR tests. The specific AIMs for achieving this goal are as follows: AIM1: To conduct 100 customer discovery interviews in South Florida a major HIV epicenter. Participants will be recruited in an intended use setting, specifically on the PrEP and the MTC ecosystems. The goal is to identify unmet needs, preferences, facilitators, and barriers to test uptake. This aim employs the I-Corps framework and builds on the PI’s three decades of HIV research, Baños national and international work on commercialization and the experience of the FIU Start-up mentor with the entire model. AIM 2: To identify and optimize critical components of the serological part of the combo test. Based on IgE Immunodiagnostic experience gained while developing prior tests and the R&D expertise of BioAmerica, Inc, we will identify the optimal combination of antibodies and antigens to support the identification of HIV during acute infection (HAI). AIM 3: To identify the best sample(s) to support HIV testing in children and adults using the rapid test platform. AIM 4: Collaboration with our biotechnology partners to produce specific IgE monoclonal antibodies based on the selected peptides in milestone Aim2-a for the development of the antigen piece of the Combo test. Innovation: Building on our prior success, our test will be unique in that it will be: • an IgE based rapid test • 5th generation test, • incorporating multiple antigens and • useful in both children and adults. In addition, we will provide new data by contrasting active IgE and passively acquired IgM binding and time responses from mother-infant pairs. Feasibility: The team expertise in key R&D areas, and the resources made available through our academic, industrial, and public health partnerships ensures the success of this proposal. Outcomes: Our updated universal rapid test will advance diagnosis by permitting the early identification of HIV in both children and adults. Our simple, rapid and equipment free test, which allows testing in the privacy of one’s own home, will expand HIV testing. Finally, the study will be a great source of data to the field and to support new grant applications.

Accurate detection of HIV during the acute phase and an over-the-counter device for self-testing would significantly impact the HIV epidemic both in the USA and globally. This proposal seeks to develop a universal antigen/antibody combo rapid test to fill these critical needs.