Fungitell® (1-3)-ß-D-Glucan Assay

Serum
check icon Optimal Result: 0 - 60 pg/mL.

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

What does it mean if your Fungitell® (1-3)-ß-D-Glucan Assay result is too high?

When Fungitell® (1→3)-β-D-glucan assay results show glucan levels of 80 pg/mL or higher, it is considered a positive result. This elevation indicates the presumptive presence of an invasive fungal infection (IFI). Here are key points to consider when interpreting elevated results:

  1. Presumptive Diagnosis: Elevated glucan levels suggest a high likelihood of an IFI. However, this should be considered a presumptive diagnosis and not a definitive confirmation.

  2. Further Diagnostic Procedures: To confirm the diagnosis, additional diagnostic procedures should be performed. These may include fungal cultures, imaging studies, and other specific fungal markers or tests.

  3. Clinical Correlation: It is essential to correlate the assay results with clinical findings. Consider the patient's symptoms, medical history, and risk factors for fungal infections.

  4. Potential Fungal Species: Elevated glucan levels may indicate the presence of fungi that produce (1→3)-β-D-glucan, such as Candida, Aspergillus, and Pneumocystis. However, it may not detect certain species like Cryptococcus, Absidia, Mucor, Rhizopus, and the yeast phase of Blastomyces dermatitidis.

  5. Immediate Action: In cases of elevated glucan levels, especially in high-risk patients, prompt medical intervention is crucial. Early antifungal treatment may significantly improve patient outcomes.

  6. Monitor Trends: Monitoring the trends of (1→3)-β-D-glucan levels over time can be helpful. Rising levels may indicate worsening infection, while decreasing levels can suggest a response to treatment.

In summary, an elevated Fungitell® (1→3)-β-D-glucan assay result (≥80 pg/mL) signifies a probable invasive fungal infection. This warrants further diagnostic investigation and potentially immediate antifungal therapy, particularly in patients with significant risk factors or clinical signs of infection.

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