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Clinical Laboratory Diagnostics for Invasive Aspergillosis

About

What services does this resource provide?

The Clinical Laboratory Diagnostics for Invasive Aspergillosis program provides two types of services:

  • Maintenance of a repository of prospectively collected clinical samples from patients at high risk for and who develop invasive aspergillosis (IA) and from subjects at high risk for IA with potentially interfering medical conditions. The collection will comprise well characterized, sequential samples spanning from pre-symptomatic through to proven IA.
  • Evaluation of experimental IA diagnostic tests performed by members of the Aspergillus Technology Consortium (AsTeC). Members will use samples from animal models of IA, the ASTEC repository, or other clinical sample repositories. Evaluations may include replication studies to determine if the experimental test performs at previously reported levels of specificity, sensitivity, and limit of detection as well as other parameters, comparison studies between Food and Drug Administration (FDA)-cleared tests for IA and experimental IA diagnostic tests, as well as studies to determine what interfering medical conditions affect performance of the investigational assay. Evaluations are performed in GLP-compliant laboratories.

As appropriate, studies may be conducted in compliance with GLP (Good Laboratory Practice).

Note: Resources are limited and intended to fill critical gaps and are not to be the sole source of product development. Preliminary data to support program participation are required.

Where are the services provided?

The study group, Aspergillus Technology Consortium (AsTeC), consists of investigators at several sites. The tissue repository is located at the University of Florida, which serves as the lead institution.

Access

Last Updated March 05, 2014