Fungitell Assay for (1,3)-B-D-Glucans
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
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.
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Beta-D glucan FORWARD
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Draw blood in a plain, red-top or serum gel tube(s). Spin down and send 0.5 mL of serum refrigerated.
NOTE: GLASS tubes are unacceptable.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Specimens other than
Anticoagulants other than
Mild OK; Gross reject
Warm reject; Cold OK
Mild OK; Gross reject
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
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
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Friday
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Performing Laboratory Location The location of the laboratory that performs the test
Beacon Diagnostics Laboratory A Division of Assoc. of Cape Cod, Inc.
CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|