The Clinical Laboratory Diagnostics for Invasive Aspergillosis contract was created to support the establishment and maintenance of a tissue repository of prospectively collected clinical samples from patients at high risk for invasive aspergillosis (IA) and from subjects at high risk for IA with potentially interfering medical conditions. Other prominent goals include the performance of comparison studies between Food and Drug Administration (FDA)-cleared tests for IA and experimental IA diagnostic tests.
The study group, Aspergillus Technology Consortium (AsTeC), consists of the following sites and investigators: University of Florida (John Wingard, M.D.), Duke University (Barbara Alexander, M.D.), Harvard University-Brigham & Women’s Hospital/Dana Farber Cancer Institute (Lindsey Baden, M.D.), Emory University (Angela Caliendo, M.D.), MiraVista (Joseph Wheat, M.D.), University of Manchester (David Denning, M.D.), and University of Pittsburgh (M-H. Nguyen, M.D.). The tissue repository will be located at the University of Florida and should be a valuable resource comprising well characterized, sequential samples spanning from pre-symptomatic through to proven disease.
It is hoped that the development of new diagnostic tests for IA will be facilitated through this contract to advance the field of contemporary clinical laboratory diagnostics for IA and improve the standard of care for patients at high risk of developing IA. The investigators will conduct studies to replicate experimental IA diagnostic tests using samples from animal models of IA, the repository, or other clinical sample repositories to determine whether the experimental test performs at previously reported levels of specificity, sensitivity, and limit of detection as well as other parameters. The investigators will then perform studies to compare the IA diagnostic test that has been replicated with an FDA-cleared IA diagnostic test.