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Test Code FUNGT Fungitell ß-D-Glucan Assay (Serum)

Important Note

STOP!

Blood must be collected in a gold-top (SST) tube.  Centrifuge and send specimen in this original collection tube.  Do not aliquot or open tube.

Clinical Indications

The Fungitell ß-D Glucan assay is indicated for the
presumptive diagnosis of invasive fungal disease through detection
of elevated levels of (1,3)- ß-D-glucan in serum. Normal
human serum contains low levels of (1,3)- ß-D glucan,
typically 10 to 40 pg/mL, presumably from commensal yeasts present
in the alimentary canal and gastrointestinal tract. However, (1,3)-
ß-D-glucan is sloughed from the cell walls during the life
cycle of most pathogenic fungi. Thus, monitoring serum for evidence
of elevated and rising levels of (1,3)- ß-D-glucan provides a
convenient surrogate marker for invasive fungal disease.

The Fungitell ß-D Glucan assay detects (1,3)-
ß-D-glucan from the following pathogens: Candida spp.,
Acremonium, Aspergillus spp., Coccidioides immitis, Fusarium spp.,
Histoplasma capsulatum, Trichosporon spp., Sporothrix schenckii,
Saccharomyces cerevisiae, and Pneumocystis jiroveci.

The Fungitell ß-D Glucan assay does not detect certain fungal
species such as the genus Cryptococcus, which produces very low
levels of (1,3)- ß-D-glucan, nor the Zygomycetes, such as
Absidia, Mucor, and Rhizopus, which are not known to produce (1,3)-
ß-D-glucan. Studies indicate Blastomyces dermatitidis is
usually not detected due to little (1,3)- ß-D-glucan produced
in the yeast phase.

Additional Test Codes

Epic Order Name: FUNGITELL (aka FUNGT)
Sunquest Order Code: FUNGT
Epic Px Code: LAB2850

Specimen Collection Type

Preferred: Gold
This tube cannot be shared with other tests.

Minimum Collection Volume

0.5 mL

Reference Range

Negative: Less than 60 pg/mL.
Indeterminate: 60 to 79 pg/mL.
Positive: Greater than or equal to 80 pg/mL

Critical Value

N/A

Interpretation

There are reports in the peer reviewed literature of lowered
assay specificity in patients with gram positive bacteremia.

Patients with renal failure on hemodialysis utilizing cellulose
membranes may have false positive results.

Patients treated with fractionated blood products such as albumin
and immunoglobulin and in specimens and subjects exposed to
glucancontaining gauze. Patients require 3 to 4 days for the
restoration of baseline levels of serum (1,3)- ß-D-glucan,
after surgical exposure to (1,3)- ß-D-glucan-containing
sponges and gauze. Accordingly, the timing of sampling of surgical
patients should take this into account.

Samples obtained by heel or finger stick methods are unacceptable
as the alcohol-soaked gauze used to prepare the site (and
potentially, the skin surface-pooling of blood) has been shown to
contaminate the specimens.

A negative test result cannot rule out the diagnosis of invasive
fungal disease. Patients at risk for invasive fungal disease should
be tested twice per week.

The performance of the Fungitell ß-D Glucan assay has not
been evaluated with specimens from neonates and infants <6
months of age.

Patients whose GI tract is colonized with Candida and have
mucositis may have a positive Fungitell ß-D Glucan assay
result without invasive fungal disease.

Rejection Criteria

Specimens that have been poured off (due to the potential for
environmental contamination of the sample that can lead to false
positive results, the gold top tubes should be centrifuged and sent
to the lab with the cap intact). Lipemic, icteric, or hemolyzed
specimens. Specimens that have been stored at ambient temperature.
Specimens that have been stored at 2 to 8°C for >5 days. If
storage longer than 5 days is needed, samples should be frozen at
-20°C or colder.

Specimen Availability for Add-on Testing

This test cannot be added on.

Specimen Stability

Frozen (preferred): greater than 5 days
Refrigerated: 5 days
Ambient: Unacceptable

Day(s) Performed

Monday through Saturday

Performing Lab- Department

TUKHS-BH-Mail Outs

CPT Code

87449

LOINC Code

42176-8

Test Alias

Beta-D-Glucan

Additional Information / Notes

Turnaround time: Same day (within 8 – 12 hours from
receipt of specimen)