Specimen:

Serum

Collection Medium:

Minimum:

Adult Absolute Minimum:  0.5 mL serum
Pediatric Absolute Minimum:  0.2 mL serum

Rejection Criteria:

Lipemic, icteric, or hemolyzed specimens.  Specimens that have been 
stored at ambient temperature.  Specimens that have been stored at 2 to 
8 degrees C for >5 days.  If storage longer than 5 days is needed, 
samples should be frozen at -70 degrees C. Unless indicated as stored 
frozen, the specimen will be rejected if the draw date is >5 days from 
receipt at reference laboratory.

Analytic Time:

24 hours (upon receipt in laboratory)

Reference Range:

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

The Fungitell beta-D Glucan assay is indicated for presumptive 
diagnosis of fungal infection. It should be used in conjunction with 
other diagnostic procedures. The Fungitell beta-D Glucan assay does not 
detect certain fungal species such as the genus Cryptococcus, which 
produces very low levels of (1,3)- beta-D-glucan. This assay also does 
not detect the Zygomycetes, such as Absidia, Mucor and Rhizopus, which 
are not known to produce (1,3)- beta-D-glucan.

Comments:

The Fungitell beta-D Glucan assay is indicated for the presumptive 
diagnosis of invasive fungal disease through detection of elevated 
levels of (1,3)- beta-D-glucan in serum. Normal human serum contains 
low levels of (1,3)- beta-D glucan, typically 10 to 40 pg/mL, 
presumably from commensal yeasts present in the alimentary canal and 
gastrointestinal tract. However, (1,3)- beta-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)- 
beta-D-glucan provides a convenient surrogate marker for invasive 
fungal disease.

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

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

Test
Limitations:

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)- beta-D-glucan, after 
surgical exposure to (1,3)- beta-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.

If a positive result is obtained, a second specimen should be collected 
and tested immediately.

The performance of the Fungitell beta-D Glucan assay has not been 
evaluated with neonatal specimens.

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

Methodology:

Enzyme Immunoassay (EIA)

CPT Code:

87449