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Fungitell® Assay

SERUM TEST FOR (1→3)-β-D-GLUCAN ANALYSIS

About Fungitell®

The Gold Standard in Rapid Screening For Invasive Fungal Infection (IFI)
Fungitell® is the first and the only FDA-cleared and CE marked rapid in vitro diagnostic screening test for IFI (including Candida, Aspergillus and Pneumocystis) that detects (1→3)-β-D-Glucan in serum.

Fungal Trends & Statistics

Invasive fungal infection: More aggressive medical care, including immunosuppressive therapy and ICU care has greatly increased the population of patients at risk of invasive fungal infection (IFI). There are an estimated 40-60 thousand invasive fungal infections in the USA annually1. Candidemia represents the 4th leading cause of nosocomial blood stream infection and the 3rd most common ICU bloodstream infection2.
The low sensitivity and relatively long incubation times of microbial culture, the most widely used diagnostic technique, has resulted in a need for faster methods with greater sensitivity. With its high sensitivity, high negative predictive value, and rapid availability of results, the use of Fungitell® has increased steadily since its clearance by the FDA in 2004.

Early diagnosis and treatment have been shown to have increased survival rates in Candidal Shock.3

Administration (Hr): Survival
0-2 ~ 82%
2-6 ~ 65%
6-12 ~ 17%
12-24 ~ 9%
24-72 ~ 8%

Why Test For (1→3)-β-D-Glucan

Most pathogenic fungi* have (1→3)-β-D-Glucan in their cell walls and minute, but detectable quantities are released into the circulation during infection. Detection of elevated levels of (1→3)-β-D-Glucan is an aid to the presumptive diagnosis of invasive fungal infection (IFI) in at risk patients.

Multiple studies4,5,6,7,8 have shown glucan to become elevated well in advance of conventional clinical signs and symptoms. The early diagnosis of and administration of therapy for invasive fungal infection is associated with improved clinical outcome; delayed diagnosis and therapy is associated with increased mortality9. Hence, there is significant utility in the application of the Fungitell® test in at risk patients.

At-Risk Patients

Invasive Fungal Infection is increasing in at-risk populations10 such as:
  • Aggressive Care (SICU/MICU/NICU)
  • Mechanical Ventilation
  • Stem Cell and Organ Transplants
  • HIV
  • Cancer Treatment
  • Diabetes
  • Central Venous Catheters
  • Hemodialysis
  • Gastrointestinal Surgery
  • Total Parenteral Nutrition

Indications

Fungitell®, an FDA cleared and CE marked diagnostic test, is used for the detection of (1→3)-β-D-Glucan, which is frequently associated with the presence of fungal pathogens. The majority of these are Candida and Aspergillus species.

There are, potentially, clinical applications that could benefit from utilizing the (1→3)-β-D-Glucan test where pneumocystosis is suspected.

Fungitell® Features & Benefits

  • Very high negative predictive value permits reduction of inappropriate systemic antifungal therapy the support of antimicrobial stewardship program goals.
  • Provides earlier support for diagnosis of IFI
  • Detects glucan from most fungi including Candida and Aspergillus*
  • Rapid results within an hour
  • FDA Cleared
  • CE Marked

Fungitell® Assay Product Information

  • Principle of the Fungitell® Reagent
    Fungitell® is a (1→3)-β-D-Glucan specific Limulus amebocyte lysate (LAL) reagent containing a chromogenic peptide substrate. (1→3)-β-D-Glucan in the sample causes activation of serine proteases. An activated protease cleaves p-nitroaniline (pNA) from the peptide substrate and the free pNA is measured at 405 nm. The test is run in a standard incubating plate reader.

  • Materials Supplied with the Kit
    • 2 vials Fungitell® Reagent
    • 2 vials Pyrosol® Reconstitution Buffera
    • 2 vials Glucan Standard
    • 2 bottles Reagent Grade Water,a 20 mL
    • 2 vials Alkaline Pretreatment Solutiona

  • Storage Conditions
    Store all reagents at 2-8°C in the dark. Reconstituted Fungitell® reagent should be stored at 2-8°C and used within 2 hours. Alternatively, reconstituted Fungitell® reagent can be frozen at -20°C for 20 days, thawed once and used.

  • Materials Required but not Supplied
    All materials and glassware must be free of interfering glucan. Dry heat depyrogenation is effective in eliminating interfering levels of (1→3)-β-D-Glucan from glass surfaces.

    Purchase supplies from a supplier that will certify the materials free of interfering glucan.
    • Repeating Pipette and tips (250 mL; 1000 mL)b
    • Test tubes for sample dilution (13 x 100 mm)b
    • Glass pipettes – not plastic
    • Parafilm®
    • Incubating plate reader capable of reading at 405 nm with appropriate kinetic software for determination of Vmeanb
    • Vortex mixer

  • Order Information
    FT001 Fungitell® Kit-110 test wells
    The Fungitell® assay is a highly sensitive, microplate-based test that detects (1→3)-β-D-Glucan in serum. (1→3)-β-D-Glucan is a cell wall constituent of most medically important fungi including Candida and Aspergillus.* (1→3)-β-D-Glucan is normally found at low levels in the blood of healthy humans. In at risk patients, serum (1→3)-β-D-Glucan values of at least 80 pg/mL, are highly associated with invasive fungal infection. Conversely, low levels of (1→3)-β-D-Glucan have a high negative predictive value for invasive fungal infection.

    (1→3)-β-D-Glucan detection is not subject to the usual interferences. It is not suppressed by anti-fungal therapy, nor is the test cross-reactive with other polysaccharides.

  • Diagnostic Performance
    Multiple studies4,5,6,7,8 in diverse patient groups have shown sensitivities from 70–100% and high negative predictive values. A variety of studies also suggest diagnostic utility in Pneumocystis jirovecii pneumonia11,12.

  • Rapid Results
    The Fungitell® assay is performed entirely within a microplate well without washing steps. The assay provides results within an hour.

  • Antimicrobial Stewardship
    Studies have shown that early discontinuation of empirical therapy in high-risk ICU patients based on consecutive negative BDG tests may be a reasonable strategy, with great potential to reduce the overuse of antifungals13.

  • Marketplace Longevity
    Fungitell® has over a decade of proven clinical use and has
    been referenced in 100+ peer-reviewed clinical papers.

  • Warnings, Precautions and Limitations
    (see instructions for use for details):
    1. The tissue locations of fungal infection and encapsulation may affect the serum concentration of (1→3)-β-D-Glucan.
    2. Some individuals have elevated levels of (1→3)-β-D-Glucan that fall into the indeterminate zone of 60 – 79 pg/mL. In such cases, additional testing is recommended.
    3. Test levels were established in adult subjects. Infant and pediatric normal levels approach those of adults. Data for neonates, and infants less than six months, are lacking.
    4. Off-color or turbid samples such as those that are grossly hemolyzed, lipemic, or contain excessive bilirubin may cause interference.
    5. Samples obtained by heel or finger stick methods are unacceptable as the alcohol-soaked gauze used to prepare the site and/or skin surface-pooling of blood may contaminate the specimens.
    6. Surgical gauzes and sponges can leach high levels of (1→3)-β-D-Glucan and may contribute to a transient positive result for the Fungitell® assay.
    7. The serum of hemodialysis patients may contain high levels of (1→3)-β-D-Glucan when certain cellulose dialysis membranes are used.
    8. In performing the test, great care must be taken to avoid contamination.
    9. The use of Fungitell® for purposes other than those described in the Intended Use section of instructions for use of the product is neither recommended nor supported by Associates of Cape Cod, Inc.

Beacon Diagnostics® Laboratory

The Beacon Diagnostics® Laboratory is a fully CLIA-certified reference laboratory specializing in (1→3)-β-D-Glucan analysis services to support the diagnosis of Invasive Fungal Infection (IFI). Serving clinical and reference laboratories, we offer a rapid, cost-effective alternative to in-house testing.

The laboratory is a division of Associates of Cape Cod, Inc. The expert staff at Beacon Diagnostics® Laboratory provides clients with rapid diagnostic and analytical service, to assist in the medical evaluation of patients suspected of having invasive fungal infection. Our laboratory also tests veterinary samples. We currently hold certifications and licenses in Massachusetts, California, Florida, Maryland, New York, Pennsylvania and Rhode Island.

Additional information concerning the Beacon Diagnostics® Laboratory services can be found on our website at www.BeaconDiagnostics.com.

Contact Us About The Fungitell® Assay

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Contact Information
Email Us At
info@acciusa.com
Call Us At
(T) 508.540.3444
(F) 508.540.8680
Where to Find Us
Associates of Cape Cod, Inc.
124 Bernard E. Saint Jean Dr.
East Falmouth, MA 02536-4445