Urine Diagnostics for Aspergillosis

DESCRIPTION provided by applicant Aspergillosis is a severe fungal infection that most frequently involves the lungs in people who have immune deficiency caused by cancer chemotherapy and or transplantation Although good drugs are available establishing a diagnosis is difficult and late treatment has limited our progress in decreasing morbidity and mortality We observed that Aspergillus polysaccharide antigens are excreted in urine in animal models and humans with disease Using a novel monoclonal Ab that detects galactofuranose containing Aspergillus antigens in urine we have developed a diagnostic test that relies on lateral flow technology enabling use at near point of care Results of proof of concept studies suggest that this device detects antigens early during the course of disease This phase I application is developed to address two aims To determine the performance characteristics of this prototype assay when used as an aid to diagnose suspected infection and To determine the performance characteristics of this assay when used to screen high risk patients for early disease Successful validation of the assay will enable phase II development for use of this novel assay in screening and early treatment strategies

PUBLIC HEALTH RELEVANCE About people in the U S are at risk for a lung infection called invasive aspergillosis which kills of people who get it The urine test we
want to develop in this application uses a new method which makes finding out who has the infection fast and easy We propose to study the urine test in people who have had invasive pulmonary aspergillosis and develop it as a screening tool for this infection in high risk patients