POINT OF CARE HIV COMBO ASSAY

Phoenix Biosystem, Inc., Pleasanton CA

Investigators

Abstract

? DESCRIPTION (provided by applicant): The earliest stages of HIV infection, the Acute HIV Infection (AHI), is critical for both individual health and HIV prevention. During AHI, establishment of latency currently renders HIV infection incurable. Persons with AHI also have high viral loads, making them highly contagious for a brief period. AHI therefore represents an important time for intervention. Identification of subjects with AHI is critical, yet challenging. Since persons are antibody-negative during AHI, HIV rapid tests, which detect HIV antibodies, cannot detect AHI. AHI can be detected only with diagnostics capable of identifying HIV RNA, DNA or p24 antigen. To date, most of these diagnostics have been laboratory-based. A rapid point-of-care test capable of distinguishing established from acute HIV infection is urgently needed. We propose to develop a user friendly, low cost HIV RNA/p24/HIV Ab Combo POC device. A key feature of our POC test is that it relies on visual detection of nucleic acid (as wel as p24 and HIV Ab) on the disposable cartridge with a readout similar to that of an HIV antibody dipstick test. However, quantitative results can be obtained by capturing the image with an integrated cell phone camera and performing image analysis with a free app (which we intend to develop in PHASE II).