Diagnostic mycology: Xtreme challenges

Brian L. Wickes, Anna M. Romanelli

Research output: Contribution to journalArticlepeer-review

13 Scopus citations


Developing any diagnostic assay that receives United States Food and Drug Administration (FDA) approval can be a slow and difficult process. FDA-approved assays for fungal diagnosis are generally few in number and are focused mainly on diagnosing candidiasis, which is caused by several species of Candida, in addition to a limited number of systemic mycotic agents. While all microbial diagnostic assays face challenges before they are FDA approved and reach the market, there are a number of challenges to fungal diagnostic assay development that have been difficult hurdles to overcome. These hurdles include template preparation, fungal morphology, how many fungi should be identified in a single assay (scope), taxonomy and nomenclature, discriminating colonizers from invasive infection, combining identification with antifungal susceptibility, and navigating the administrative hurdles required to integrate an assay into a clinical laboratory. Some of these challenges are easier to overcome than others, but all seem to be particularly difficult for fungal diagnostic assays.

Original languageEnglish (US)
Article numbere01345-19
JournalJournal of clinical microbiology
Issue number4
StatePublished - 2020


  • Antifungal
  • Molds
  • Mycoses
  • Nomenclature
  • Susceptibility testing
  • Yeast

ASJC Scopus subject areas

  • Microbiology (medical)


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