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