Fungitell Assay for (1,3)-B-D-Glucans
The use of Fungitell-based patient results supplied by Beacon
Diagnostics Laboratory is restricted to that described in the
Intended Use section of the Fungitell Instructions For Use.
Beacon Diagnostics Laboratory-supplied Fungitell test results
for purposes beyond those described in the Intended Use
Section are not authorized by Beacon Diagnostics Laboratory.
Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
Negative: Less than 60 pg/mL
Indeterminate: 60-79 pg/mL
Positive: Greater than or equal to 80 pg/mL
Note: The Fungitell assay is indicated for presumptive diagnosis of fungal infection. It should be used in conjunction with other diagnostic procedures. The Fungitell assay does not detect certain fungal species such as the genus Cryptococcus, which produces very low levels of (1-3)-B-D-Glucan. This assay also does not detect the Zygomycetes, such as Absidia, Mucor, and Rhizopus which are not known to produce (1-3)-B-D-Glucan.
Serum glucan concentrations greater than or equal to 80 pg/mL are interpreted as a positive result. A positive result means that (1-3)-B-D-Glucan was detected in the serum sample submitted. A positive result does not define the presence of disease and should always be used in conjunction with other clinical findings to establish a diagnosis.
The Fungitell assay detects (1-3)-B-D-Glucan regardless of its origin. Therapeutic interventions should be evaluated for their potential to contribute to serum burdens of (1-3)-B-D-Glucan. Special care should be taken in patient sample handling so as to avoid the introduction of contaminant (1-3)-B-D-Glucan. The presence in a patient sample of (1-3)-B-D-Glucan from a source other than fungal infection could cause a positive assay result that is inconsistent with the patient’s clinical condition.
Test Performed By: Beacon Diagnostics Laboratory
A Division of Associates of Cape Cod, Inc.
124 Bernard E. Saint Jean Drive
East Falmouth, MA 02536-4445