Lateral Flow Assay for Diagnosis of Histoplasmosis

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 DESCRIPTION (provided by applicant): Progressive disseminated histoplasmosis is a common and serious opportunistic infection among individuals with HIV/AIDS. In many resource-limited areas, such as Latin America, incidence rates in HIV/AIDS can be >20%, with mortality rates among cases >30%. Successful treatment of histoplasmosis in patients with AIDS requires early diagnosis and treatment. As a consequence, there is a critical need for a rapid, effective and low-cost point-of-care (POC) diagnostic test for histoplasmosis. Currently, diagnosis of histoplasmosis relies on demonstration of the fungus in clinical specimens by histopathology or culture. Such methods have a low sensitivity, are time consuming, are expensive, and require trained personnel. An alternative approach to diagnosis is detection of shed fungal antigens in body fluids such as blood or urine. Immunoassays are a well-established means to diagnose fungal and microbial infections for a broad spectrum of infectious diseases. Importantly, immunoassays are readily adaptable to a POC format using platform technologies such as a lateral flow assay (LFA). In the Phase I STTR Grant #1 5R41AI096945-02 entitled "Point-of-care immunoassay for diagnosis of histoplasmosis in HIV/AIDS" a monoclonal antibody to a Histoplasma polysaccharide was developed and used to develop an LFA that accurately detects the presence of Histoplasma antigen in the urine of infected patients. The goal of this Phase II project is to further develop and validate the Histoplasma LFA for definitive diagnosis of histoplasmosis in the urine of HIV/AIDS infected patients in South America. Criteria for success of this Phase II SBIR proposal would be the generation of data to support a 510k application of a diagnostic assay that would definitively detect the presence of Histoplasma in the urine of infected patients, which could ultimately result in a dramatic decrease in the mortality associated with this disease.