POINT OF CARE HIV COMBO ASSAY

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 p 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 p 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 p 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 PUBLIC HEALTH RELEVANCE African Americans accounted for an estimated of all new HIV infections among adults and adolescents aged years or older in despite representing only of the US population considering the smaller size of the African American population in the United States this represents a population rate that is times that of whites overall The estimated rate of new HIV infections for African American women was times that of white women and almost times that of Hispanic Latino women In the United States African Americans Latinos and women frequently undergo HIV testing only after the development of symptoms Targeted testing of individuals at higher risk for HIV in non medical settings has the potential to reduce HIV associated morbidity and mortality and reduce transmission