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.
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.
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.
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|
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.
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.
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.
The Fungitell® assay is performed entirely within a microplate well without washing steps. The assay provides results within an hour.
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.
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):