DEVELOPMENT AN EASY-TO-USE DIAGNOSTIC TEST CAPABLE OF EARLY, RAPID DETECTION OF TALAROMYCES ANTIGEN IN HUMAN SERUM, PLASMA, AND/OR URINE.

Talaromycosis is caused by the dimorphic fungus Talaromyces (formerly Penicillium) marneffei endemic in Southeast Asia. In just over two decades, the HIV epidemic has transformed talaromycosis from a rare infection to a leading opportunistic infection and cause of death in individuals living with HIV in Southeast Asia. The current diagnosis of talaromycosis is unacceptable, as it relies on decades-old culture methods or on histopathological evaluation; both of which require facility and expertise that do not exist outside of major hospitals in large cities in Asia. An accurate POC assay would enable doctors in the most remote districts and villages in Southeast Asia to make a diagnosis without having to refer patients to central hospitals, which would dramatically reduce the time to diagnosis, would enable early antifungal therapy, thus has the potential to substantially reduce morbidity and mortality while saving health care and patient costs. The goals of this project are to develop, optimize, and validate a lateral flow assay for the rapid detection of Talaromyces antigens in human serum, plasma, and/or urine. Criteria for success in the Phase I SBIR proposal would be development of the Talaromyces Antigen LFA and determination of its performance characteristics.