The goal of this NIH SBIR Phase I proposal is to develop a low-cost and rapid point-of-care (POC) p24 test forearly detection of human immunodeficiency virus (HIV) infection. It will be appropriate for use at decentralizedsettings in developed and developing countries where the limitations of infrastructure and laboratory capabilityprohibit viral load-based nucleic acid testing. Our aim is to maintain the accuracy and sensitivity of traditionallab-based diagnostics while providing a device that a minimally trained person can operate, significantlyincreasing access to HIV diagnostics. The WHO guidelines recommend initiating antiretroviral therapy (ART) asearly as possible once infected, and the Joint United Nations Programme on HIV and AIDS (UNAIDS) has calledfor global increases in HIV testing, treatment, and viral suppression. However, because a significant proportionof individuals are unaware of their infection, expanding testing capabilities has a high potential to reach previouslyuntested high-risk populations. Current point-of-care devices that can detect HIV viremia directly are tooexpensive and require some level of specialized training to operate. Also, many POC technologies that havebeen approved are not sensitive enough to detect HIV during peak viremia and transmissibility in acute infection.Existing self-testing technologies only detect the host antibody response, which arises weeks after the initialinfection. Therefore, practical and affordable POC test platforms that enable decentralized testing will beimportant for the federal "Ending the HIV Epidemic: A Plan for America" initiative. To this end, AI Biosciencesproposes to develop a low-cost magnetic particle (MP) and nanoparticle based sandwich immunoassay that canbe used for the early-detection of HIV-1 p24 capsid protein with a sensitivity near that of nucleic acid amplificationapproaches. This small device (~4x3x2 inches) performs MP-based p24 capture and concentration, followed bylabeling with antibody-modified platinum nanoparticles (PtNPs). The PtNPs then interact with a hydrogenperoxide solution to create a signal that can be recorded with extremely high sensitivity using low-cost electroniccomponents. We aim to optimize the chemistry and assay form factor during Phase I to make a 30-min sample-to-answer test that requires minimal training and hands-on time. We will work with Professor Chuan-Jian Zhong,a nanotechnology and catalysis expert at Binghamton University (BU), to characterize and synthesize theantibody modified MPs and PtNPs. AI Biosciences has also partnered with Professor Jeanne Jordan of GeorgeWashington University (GWU)to assist with device evaluation and testing. At the end of Phase I, we will bringour device and assay to her laboratory to perform a technology demonstration. We will train technicians to useour device and assay for validation. They will compare the results from our immunoassay to PCR and 5thgeneration immunoassays. If our approach for sensitive p24 detection is successful, we will use the sameapproach for HIV antibody detection.
Public Health Relevance Statement: PROJECT NARRATIVE
We propose to develop an easy-to-use, low-cost instrument and fluidic chip to enable POC testing of acute HIV-
1 infection within the first two weeks of infection. This will allow infected individuals to seek professional help so
their physician can initiate antiretroviral therapy as early as possible post-infection. The proposed project will
demonstrate our proof of concept that is compact and cost-effective for the ultrasensitive detection of p24
antigens.
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