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Development of Rapid, Point-of-Care Tests for Diagnosis of Fungal Infections



Fungi are some of the most common causes of major HIV-related opportunistic infections in the world. Cryptococcal meningitis is estimated to kill more HIV-infected persons than tuberculosis in sub-Saharan Africa. Pneumocystis pneumonia is the most common cause of acute pneumonia in most areas; histoplasmosis is extremely common in Central and South America, and penicilliosis marneffei is highly endemic in Southeast Asia. Prevention of serious sequelae (meningitis, respiratory failure, bloodstream infection) and death in these patients depends on prompt diagnosis and treatment. However, in many resource-poor areas, diagnosis of these infections is not possible because diagnostic tests are not available.

Project Goal:  The goal of this project is the development of rapid, simple, affordable laboratory tests that are designed to be used in resource-poor settings to diagnose these diseases, and to distinguish them from other non-fungal diseases with similar symptoms. Such tests are feasible: a lateral flow “dipstick” test for Cryptococcus is in development and shows promise.

Rapid fungal diagnostics is an area that should be of particular interest to small business concerns. Laboratories in developing countries have either no alternative methods, or only elaborate and inefficient methods, to diagnose fungal infections at this time. The developed assays should have the characteristics of simplicity and robustness as described by the World Health Organization. Innovative approaches such as “dipstick” technology that can be used in the clinic and the field are already being employed in areas such as malaria diagnostics, showing proof-of-concept. Such rapid fungal diagnostics can be incorporated into resource-poor countries as laboratory capacity-building efforts develop and continue.

Impact:  Rapid point-of-care tests can reduce deaths, hospitalization, and other serious sequelae (including immune reconstitution syndrome) among HIV-infected persons by differentiating these diseases from other clinically similar ones, thereby allowing for appropriate therapy. The primary benefit of such diagnostics is in resource-poor countries where HIV incidence is high, but market opportunities also exist in the United States where these fungal infections also occur in high-risk patient populations.

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