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Test Code Billings Clinic: 1356 Mayo: SFUNG 1,3-Beta-D-Glucan (Fungitell), Serum

Reporting Name

(1, 3) Beta-D-Glucan (Fungitell), S

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Useful For

Aiding in the diagnosis of invasive fungal infections caused by various fungi, including Aspergillus species, Fusarium species, Candida species, and Pneumocystis jiroveccii, among others

Method Name

Protease Zymogen-Based Colorimetric Assay

Specimen Type

Serum SST


Specimen Required


Container/Tube: Serum gel

Specimen Volume: 1 mL

Collection Instructions:

1. Avoid exposure of specimen to atmosphere to prevent environmental contamination of the sample.

2. Centrifuge and send specimen in original collection tube. Do not aliquot or open tube.


Specimen Minimum Volume

0.5 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum SST Refrigerated (preferred) 14 days SERUM GEL TUBE
  Frozen  30 days SERUM GEL TUBE

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject

Reference Values

FUNGITELL QUANTITATIVE VALUE:

<60 pg/mL

 

FUNGITELL QUALITATIVE RESULT:

Negative

 

Reference values apply to all ages.

Interpretation

The Fungitell assay should be used in conjunction with other diagnostic procedures, such as routine bacterial/fungal cultures, histologic examination of biopsy material and radiologic studies.

 

Positive:

(1,3)-Beta-D-glucan detected. A single positive result should be interpreted with caution and correlated alongside consideration of patient risk for invasive fungal disease, results of routine laboratory tests (eg, bacterial and fungal culture, histopathologic evaluation) and radiologic findings. Repeat testing on a new sample (collected in 3-4 days) is recommended as serially positive samples are associated with a higher diagnostic odds ratio for invasive fungal infection compared to a single positive result.

 

False-positive results may occur in patients who have recently (in the past 3-4 days) undergone hemodialysis, treatment with certain fractionated blood products (eg, serum albumin, immunoglobulins), or those who have had significant exposure to glucan-containing gauze during surgery.

 

This assay does not detect certain fungi, including Cryptococcus species, which produce very low levels of (1,3)-Beta-D-glucan (BDG) and the Mucorales (eg, Lichthemia, Mucor, and Rhizopus), which are not known to produce BDG. Additionally, the yeast phase of Blastomyces dermatitidis produces little BDG and may not be detected by this assay.

 

Indeterminate:

Repeat testing on a new sample is recommended in patients at risk for an invasive fungal infection.

 

This assay does not detect certain fungi, including Cryptococcus species, which produce very low levels of (1,3)-Beta-D-glucan (BDG) and the Mucorales (eg, Lichthemia, Mucor, and Rhizopus), which are not known to produce BDG. Additionally, the yeast phase of Blastomyces dermatitidis produces little BDG and may not be detected by this assay.

 

Negative:

No (1,3)-Beta-D-glucan detected.

 

This assay does not detect certain fungi, including Cryptococcus species, which produce very low levels of (1,3)-Beta-D-Glucan (BDG) and the Mucorales (eg, Lichthemia, Mucor, and Rhizopus), which are not known to produce BDG. Additionally, the yeast phase of Blastomyces dermatitidis produces little BDG and may not be detected by this assay.

Day(s) and Time(s) Performed

Monday through Saturday; 9 a.m.

Sunday; 7 a.m.

Test Classification

This test has been cleared or approved by the U.S. Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

87449

LOINC Code Information

Test ID Test Order Name Order LOINC Value
SFUNG (1, 3) Beta-D-Glucan (Fungitell), S 42176-8

 

Result ID Test Result Name Result LOINC Value
603615 Fungitell Quantitative Value 42176-8
603616 Fungitell Qualitative Result 93812-6