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Fungitell® (1-3)-β-D-Glucan Assay
Test Code16283
Alias/See Also
LAB00484
BD GLUCAN
FUNGITELL
BD GLUCAN
FUNGITELL
CPT Codes
87449
Preferred Specimen
1 mL serum
Minimum Volume
0.5 mL
Instructions
Draw blood in plain red-top tube or serum separator tube (SST), spin down, then aliquot into a sterile screw-cap container or sterile glucan-free (DNAse, RNAse, pyrogen-free) tube.
Transport Container
Sterile screw-cap container or Glucan-free transport tube
Transport Temperature
Refrigerated (cold packs)
Specimen Stability
Room temperature: Unacceptable
Refrigerated: 15 days
Frozen: 27 days
Refrigerated: 15 days
Frozen: 27 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Hemolysis • Lipemia • Icteric • Turbid serum • Glass tubes
Methodology
Protease Zymogen-based Colorimetric
Setup Schedule
Daily
Report Available
2-4 days
Reference Range
<60 pg/mL
Clinical Significance
This assay is used for the qualitative detection of (1-3)-beta-D-glucan, a fungal cell wall antigen, in patients suspected of invasive fungal infection. The serum levels of (1-3)-beta-D-glucan can be used to aid in diagnosing deep-seated mycoses and fungemia and should be used in conjunction with other diagnostic tests and clinical criteria.
This assay is generally used as a non-invasive test for patients with symptoms consistent with invasive fungal infection or with medical conditions that put them at higher risk of infection. Patients with hematologic malignancies, organ and hematopoietic stem cell transplants, or those receiving immunosuppressive therapy are at higher risk of invasive fungal infection.
This assay is a pan-fungal antigen test and therefore can detect (1-3)-beta-D-glucan from several pathogenic and opportunistic fungal pathogens, if it is present above the limit of detection. A positive result does not indicate infection with any specific genus or species of fungi. In addition, infection may not lead to elevated levels of (1-3)-beta-D-glucan in the serum. This assay does not detect (1-3)-beta-D-glucan from infections caused by Mucorales (eg Lichtheimia, Mucor, and Rhizopus), Blastomyces spp, or Cryptococcus spp.
False-positive results have been reported in patients using certain fractionated blood products, such as serum albumin and immunoglobulins, and in specimens exposed to glucan-containing gauze and surgical sponges.
References:
1. Fungitell Assay. Instructions for use.
2. CLSI M53 2nd edition
3. Lamoth, F. et al. Assessment of the Role of 1,3-β-d-Glucan Testing for the Diagnosis of Invasive Fungal Infections in Adults. Clin Infect Dis. 2021 Mar 12;72(Suppl 2):S102-S108. doi: 10.1093/cid/ciaa1943.
This assay is generally used as a non-invasive test for patients with symptoms consistent with invasive fungal infection or with medical conditions that put them at higher risk of infection. Patients with hematologic malignancies, organ and hematopoietic stem cell transplants, or those receiving immunosuppressive therapy are at higher risk of invasive fungal infection.
This assay is a pan-fungal antigen test and therefore can detect (1-3)-beta-D-glucan from several pathogenic and opportunistic fungal pathogens, if it is present above the limit of detection. A positive result does not indicate infection with any specific genus or species of fungi. In addition, infection may not lead to elevated levels of (1-3)-beta-D-glucan in the serum. This assay does not detect (1-3)-beta-D-glucan from infections caused by Mucorales (eg Lichtheimia, Mucor, and Rhizopus), Blastomyces spp, or Cryptococcus spp.
False-positive results have been reported in patients using certain fractionated blood products, such as serum albumin and immunoglobulins, and in specimens exposed to glucan-containing gauze and surgical sponges.
References:
1. Fungitell Assay. Instructions for use.
2. CLSI M53 2nd edition
3. Lamoth, F. et al. Assessment of the Role of 1,3-β-d-Glucan Testing for the Diagnosis of Invasive Fungal Infections in Adults. Clin Infect Dis. 2021 Mar 12;72(Suppl 2):S102-S108. doi: 10.1093/cid/ciaa1943.
Performing Laboratory
| Quest Diagnostics Nichols Institute-San Juan Capistrano, CA |
| 33608 Ortega Highway |
| San Juan Capistrano, CA 92675-2042 |