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Clinical Laboratory Diagnostics for Invasive Aspergillosis

Application and Approval Process

Step 1 – Discuss the potential request informally with the Program Officer
Contact the Program Officer in the Division of Microbiology and Infectious Diseases to discuss your preliminary data and the suitability of your proposed studies for support vis a vis the standard criteria listed below.
  • Proposed studies within the DMID/NIAID mission
  • Proposed studies within the scope of and/or technology provided by awarded contracts
  • Sufficient quality and/or quantity of product available
  • Proposed work not supported by other funding sources/available from other sources
  • Previous use of DMID resources for assessment of the same or similar product (Repeat use of DMID resources may be undertaken with strong justification.)
  • Preliminary data adequate to support the request to advance the product to the next step in the product development pipeline
  • Likelihood that services will contribute significantly to the eventual development and/or evaluation of a product of high quality
  • Purported public health impact
  • Improvements in health benefits offered beyond current measure(s)
  • Availability of a plan for advancing the product beyond completion of the services requested
Step 2 – Submit a formal proposal
To apply for services, users should complete the Application for Assay Evaluation.

For each candidate test, the manufacturer is expected to provide sufficient information about the test to judge its merit and to establish procedures for performance of the assay.

The AsTeC Review Committee, comprised of the Principal Investigator (PI), Co-PIs, and the Project Officer, will prioritize experimental tests for evaluation using guidelines developed with the advice of a Scientific Working Group (SWG). The SWG is comprised of three external scientists knowledgeable in IA diagnostics and FDA requirements for in vitro diagnostic test evaluations.

Last Updated March 05, 2014