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

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.

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.

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.