Beta-D Glucan Assay

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  • Test Code

    317

  • Clinical Significance

    The Fungitell® assay measures the presence of (1→3)-β-D-Glucan in serum and CSF. Serum is the only specimen type cleared by the FDA for this assay. Performance characteristics of CSF have been validated by MiraVista Diagnostics.

  • Methodology

    Colorimetric Fungitell® assay utilizing a (1→3)-β-D-Glucan -specific Limulus Amebocyte Lysate (LAL) reagent.

  • Limitations

    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.
    • – 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.
    • – 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.
  • Specimen Collection

    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.

  • Minimum Specimen Requirements

    Serum: 0.2 mL

  • Specimen Stability
    • Room Temperature: Not acceptable
    • Refrigerated: 5 days
    • Frozen: Indefinitely
  • Specimen Rejection
    • – Lipemic, hemolyzed or icteric specimens
    • – May be rejected due to interference
  • Transport Temperature

    Refrigerated/Frozen

  • Shipping

    Ship on dry ice or frozen packs for next day service. Monday – Friday delivery

  • Turnaround Time

    Testing is performed Monday-Friday.

    Serum: 1-2 days

  • Reference Range

    None detected

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

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

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