BETA-D GLUCAN ASSAY

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The purpose of the Fungitell® assay is to detect (1→3 )-β-D-Glucan in pathogenic fungi caused by invasive fungal disease. Infections caused by Candida spp., Aspergillus spp., Fusarium spp., Trichosporon spp., Saccharomyces cerevisiae, Acremonium spp., Coccidioides immitis, Histoplasma capsulatum, Sporothrix schenckii, and Pneumocystis jirovecii are some of the fungal infections that can be detected using the kit. A positive result does not indicate which class of fungi may be causing infection. Fungitell® should be used in conjunction with other diagnostic procedures, such as microbiological culture, histological examination of biopsy samples and radiological examination.

Colorimetric Fungitell® assay utilizing a (1→3)-β-D-Glucan -specific Limulus Amebocyte Lysate (LAL) reagent.The result is not intended to be used as the sole means for clinical diagnosis or patient management decisions.

The result is not intended to be used as the sole means for clinical diagnosis or patient management decisions.

• Does not detect certain fungal species, such as Cryptococcus sp. and Blastomyces dermatitidis, which produce very low levels of (1→3)-β-D-Glucan or Zygomycetes, such as Absidia, Mucor and Rizopus, which are not known to produce (1→3)-β-D-Glucan.
• False positive results have been found in hemodialysis patients, subjects treated with certain fractionated blood products, such as serum albumin and immunoglobulins and in specimens or subjects exposed to glucan-containing gauze. Patients require 3-4 days for restoration of baseline levels of (1→3)-β-D-Glucan after surgical exposure to (1→3)-β-D-Glucan containing sponges and gauze. The timing of sampling from surgical patients should take this into consideration.
• Samples obtained by finger or heel stick methods are unacceptable as the alcohol-soaked gauze used to prepare the site has been shown to contaminate the specimen.
• The assay has not been validated for use in neonates and infants less than six months of age.
• Patients whose GI tract is colonized with Candida and have mucositis may have a positive test result without invasive fungal disease.
• A negative test result cannot rule out the diagnosis of invasive fungal disease.
• Positive results should be confirmed.

• Serum: Collect serum specimens in serum separator or red top tube. Allow blood to clot for 30 minutes, then centrifuge. Pipette serum into a transport tube without interfering levels of (1→3)-β-D-Glucan. Most sterile polypropylene DNAase and RNAse free tubes are acceptable.
• CSF: Submit CSF in a sterile leak-proof container.
• New York approved for Serum samples.

Serum/CSF : 0.25 mL

• Room Temperature: Not acceptable.
• Refrigerated: 15 days
• Frozen: 27 days

• Lipemic, hemolyzed or icteric specimens
• Any specimen types other than serum or CSF
• Samples shipped at ambient temperatures
• May be rejected due to interference

Refrigerated/Frozen

Ship on dry ice for next day service. Frozen ice packs may be substituted if sample is shipped the day of collection. Monday – Friday delivery

Testing is performed Monday-Friday.

Serum/CSF: Same Day**

**Test Set up: Samples for Antigen testing received by 10:30AM will have same day test set up. Positive samples may require confirmation which could extend turnaround time. Serum & CSF specimens are pretreated to improve sensitivity, which can add one day to turnaround time.

None detected.

• Negative: <60 pg/mL
• Indeterminate: 60 pg/mL – 79 pg/mL
• Positive: 80 pg/mL – >500 pg/mL

Fungitell® is a registered trademark of Associates of Cape Cod Inc.