Fungitell® is the first and only FDA-cleared and CE-marked rapid in vitro diagnostic screening test for invasive fungal infections (IFI), including Candida, Aspergillus, and Pneumocystis. It detects (1→3)-β-D-Glucan in serum.
This assay aids in the presumptive diagnosis of fungal infections and should be used alongside other diagnostic procedures.
Glucan Value Interpretation
- Values <60 pg/mL: Considered negative, indicating the presumptive absence of fungal infection.
- Values between 60 and <80 pg/mL: Considered indeterminate.
- Values ≥80 pg/mL: Considered positive, indicating the presumptive presence of a fungal infection.
Certain fungal species that do not produce or produce low levels of (1→3)-β-D-glucan, such as Cryptococcus, Absidia, Mucor, Rhizopus, and the yeast phase of Blastomyces dermatitidis, may not be detected by this assay.
Importance of (1→3)-β-D-Glucan Assay
Invasive fungal infections (IFI) are increasingly common, particularly among immunocompromised patients. Most pathogenic fungi contain (1→3)-β-D-glucan in their cell walls, which is released into the bloodstream during infection. Monitoring serum (1→3)-β-D-glucan levels provides a useful surrogate marker for IFI.
Fungal Trends & Statistics
The rise in invasive fungal infections is linked to more aggressive medical treatments, such as immunosuppressive therapy and intensive care unit (ICU) care. Annually, there are an estimated 40-60 thousand cases of invasive fungal infections in the USA. Candidemia is the fourth leading cause of nosocomial bloodstream infections and the third most common ICU bloodstream infection.
Traditional microbial culture techniques, while widely used, have low sensitivity and long incubation times, underscoring the need for faster and more sensitive diagnostic methods. Since its FDA clearance in 2004, Fungitell® has gained popularity due to its high sensitivity, high negative predictive value, and rapid results.
Early diagnosis and treatment have been shown to increase survival rates in cases of candidal shock.
Why Test for (1→3)-β-D-Glucan?
Most pathogenic fungi have (1→3)-β-D-glucan in their cell walls. During infection, small but detectable quantities of this glucan are released into the bloodstream. Detecting elevated levels of (1→3)-β-D-glucan aids in the presumptive diagnosis of invasive fungal infections (IFI) in at-risk patients.
At-Risk Patient Populations
- Cancer patients undergoing chemotherapy
- Stem cell and organ transplant patients
- Burn patients
- HIV patients
- ICU patients
Fungitell® (1-3)-ß-D-Glucan Assay
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