Fungitell Approved for Diagnosis of Invasive Fungal Infections
The Associates of Cape Cod (ACC) announced that the FDA has given clearance for the Fungitell assay, a highly sensitive, rapid diagnostic test to detect (1,3)-b-D-glucan in blood serum. This assay is indicated for use as a diagnostic aid in clinical situations where rapid results concerning invasive fungal infection are required.
During an infection, (1,3)-b-D-glucan produced by certain fungal pathogens may be released into the bloodstream, which can be detected by the Fungitell assay using patient blood serum. The detection reagent is a biological cascade based upon modified Limulus Amebocyte Lysate (LAL), an extract of the blood cells of the North American Horseshoe Crab.
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