Immuno-mycologics, Inc. — Department of Health and Human Services SBIR Phase II: NIAID

Description

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 andgt with mortality rates among cases andgt 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 R AI entitled andquot Point of care immunoassay for diagnosis of histoplasmosis in HIV AIDSandquot 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 k 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 PUBLIC HEALTH RELEVANCE 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 andgt with mortality rates among cases andgt This is a translational research study whose goal is to validate a novel lateral flow assay LFA for diagnosis of histoplasmosis in clinical patient specimens In the Phase I STTR Grant R AI entitled andquot Point of care immunoassay for diagnosis of histoplasmosis in HIV AIDSandquot 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 success of this study will ultimately facilitate the definitive detection of Histoplasma in the urine of infected patients which could ultimately resul in a dramatic decrease in the mortality associated with this disease