Abstract
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 language | English (US) |
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Article number | e01345-19 |
Journal | Journal of clinical microbiology |
Volume | 58 |
Issue number | 4 |
DOIs | |
State | Published - 2020 |
Keywords
- Antifungal
- Molds
- Mycoses
- Nomenclature
- Susceptibility testing
- Yeast
ASJC Scopus subject areas
- Microbiology (medical)