A sensitive, low-cost, fluorescence assay for determination of HIV p24 in infants

DESCRIPTION (provided by applicant): Each year, 1.5 million children are born to mothers living with HIV resulting in vertical transmission of HIV to newborns in 350,000 cases. Early testing followed by prompt anti-retroviral therapy (ART) is known to savelives, yet lack of point-of-care (POC) tests for infants results in delays or absence of therapy. Our approach will provide a low-cost yet quantitative and sensitive lateral flow immunoassay (LFIA) test to analyze and quantitate the presence of HIV p24.Fluorescent dyes will be used to improve the limit of detection compared to existing rapid tests. A smart phone is utilized for imaging, analysis and automated reporting. A long Stokes shift dye, R-phycoerythrin (PE) will be used as the fluorescent reporter, either singly or bundled into a cluster. The optical properties of PE allow the use of an inexpensive illumination device; the minimal non-specific binding of PE results in sensitive detection with a wide dynamic range. Additional gains in sensitiv