Test Catalog

Test Id : SFUNG

1,3-Beta-D-Glucan (Fungitell), Serum

Useful For
Suggests clinical disorders or settings where the test may be helpful

Aiding in the diagnosis of invasive fungal infections caused by various fungi, including Aspergillus species, Fusarium species, Candida species, and Pneumocystis jiroveccii, among others

Highlights

The Fungitell assay may aid in identifying deep-seated fungal infections or fungemia in patients with symptoms of, or with a medical condition predisposing the patient to, an invasive fungal infection.

 

The Fungitell assay detects circulating (1,3)-beta-D-glucan in serum. This antigen is released from many invasive fungal organisms (eg, Candida species, Aspergillus species, Fusarium species, and Pneumocystis jirovecii).

Method Name
A short description of the method used to perform the test

Protease Zymogen-Based Colorimetric Assay

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

(1, 3) Beta-D-Glucan (Fungitell), S

Aliases
Lists additional common names for a test, as an aid in searching

Fungal antigen

BDG

Candida antigen

Specimen Type
Describes the specimen type validated for testing

Serum SST

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Container/Tube: Serum gel (red top tube is not acceptable)

Specimen Volume: 1 mL

Collection Instructions:

1. Avoid exposure of specimen to atmosphere to prevent environmental contamination of the sample.

2. Centrifuge and send specimen in original collection tube. Do not aliquot or open tube.

Forms

If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

-General Request (T239)

-Microbiology Test Request (T244)

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.5 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Serum SST Refrigerated (preferred) 14 days SERUM GEL TUBE
Frozen 30 days SERUM GEL TUBE

Useful For
Suggests clinical disorders or settings where the test may be helpful

Aiding in the diagnosis of invasive fungal infections caused by various fungi, including Aspergillus species, Fusarium species, Candida species, and Pneumocystis jiroveccii, among others

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Invasive fungal infections (IFI) due to opportunistic fungal pathogens are a significant cause of morbidity and mortality, particularly among patients who are significantly immunosuppressed including hematopoietic stem cell transplant recipients, solid organ transplant recipients, and those with hematologic or immune deficiencies. Patient recovery and survival following an IFI is directly related to the timely clinical recognition and prompt administration of antifungal therapy. Laboratory diagnosis of IFI is largely based on direct microscopic examination of patient specimens, histopathologic examination of tissue biopsies, isolation of fungi via culture, and, more recently, through molecular methods. However, these techniques commonly require invasive sample collection methods (eg, biopsy, bronchoalveolar lavage), which may be contraindicated in certain patients. Additionally, both microscopy and culture are frequently insensitive, with prior studies showing the sensitivity of culture for invasive Aspergillus infections ranges from 40% to 85%, and some fungi require prolonged incubation times, limiting the utility of culture in the acute patient setting. Due to these limitations, use of fungal biomarkers, including detection of (1,3)-beta-D-glucan (BDG), have emerged as useful adjunct tests available for detection of IFI.

 

BDG is found in the cell walls of most fungi (eg, Candida, Aspergillus, Fusarium, Pneumocystis jirovecii) with the notable exception of Cryptococcus species, Blastomyces species, and the Mucorales (eg, Lichthemia, Mucor, Rhizopus), which either lack BDG entirely or produce it in very low amounts. Elevated serum BDG levels have been associated with the presence of a fungal infection. The BDG levels may be, detected prior to the development of clinical symptoms and before isolation or identification of the fungal organism via routine methods. The sensitivity and specificity of BDG detection in patients with proven or probable IFI ranges from 64% to 93% and 87% to 100%, respectively, among different studies.

 

Importantly, the BDG assay should not be used alone to diagnose an IFI, but rather in conjunction with careful evaluation of patient risk factors for infection, other laboratory testing, and radiologic findings.

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.

FUNGITELL QUANTITATIVE VALUE:

<60 pg/mL

 

FUNGITELL QUALITATIVE RESULT:

Negative

 

Reference values apply to all ages.

Interpretation
Provides information to assist in interpretation of the test results

The Fungitell assay should be used in conjunction with other diagnostic procedures, such as routine bacterial/fungal cultures, histologic examination of biopsy material and radiologic studies.

 

Positive:

(1,3)-Beta-D-glucan detected. A single positive result should be interpreted with caution and correlated alongside consideration of patient risk for invasive fungal disease, results of routine laboratory tests (eg, bacterial and fungal culture, histopathologic evaluation) and radiologic findings. Repeat testing on a new sample (collected in 3-4 days) is recommended as serially positive samples are associated with a higher diagnostic odds ratio for invasive fungal infection compared to a single positive result.

 

False-positive results may occur in patients who have recently (in the past 3-4 days) undergone hemodialysis, treatment with certain fractionated blood products (eg, serum albumin, immunoglobulins), or those who have had significant exposure to glucan-containing gauze during surgery.

 

Indeterminate:

Repeat testing on a new sample is recommended in patients at risk for an invasive fungal infection.

 

Negative:

No (1,3)-Beta-D-glucan detected.

 

This assay does not detect certain fungi, including Cryptococcus species, which produce very low levels of (1,3)-beta-D-glucan (BDG) and the Mucorales (eg, Lichthemia, Mucor, and Rhizopus), which are not known to produce BDG. Additionally, the yeast phase of Blastomyces dermatitidis produces little BDG and may not be detected by this assay.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

(1, 3)-Beta-D-glucan (BDG) is not present in the Mucorales (eg, Lichthemia, Mucor, Rhizopus), Cryptococcus species or Blastomyces species. Therefore, invasive fungal infection with either of these agents will lead to a negative BDG result.

 

BDG results should be interpreted alongside other diagnostic testing results, including culture, molecular assays, or serology.

 

False-positive BDG results have been documented in patients having undergone recent hemodialysis, those that have received certain fractionated blood products (eg, albumin, immunoglobulins), and those who have had exposure to high amounts of glucan-containing gauze during surgery. BDG levels normalize approximately 3 to 4 days following these events.

 

Single time-point testing with the BDG assay is associated with limited clinical sensitivity and specificity. Serial testing, at least 2 times per week, is associated with higher diagnostic odds ratio (DOR 112) for the presence of an invasive fungal infection in an at-risk patient compared to single time-point positive result (DOR 16).

 

The BDG assay does not identify or indicate the presence of a specific fungal organism.

 

Serial testing to document BDG levels may be used to monitor disease progression and response to therapy, however, data on the clinical utility and accuracy of this practice is limited.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Theel ES, Doern CD: Beta-D-glucan testing is important for diagnosis of invasive fungal infections. J Clin Microbiol. 2013 Nov;51(11):3478-3483

2. Karageorgopoulos DE, Vouloumanou EK, Ntziora F, Michalopoulos A, Rafailidis PI, Falagas ME: Beta-D-glucan assay for the diagnosis of invasive fungal infections: a meta-analysis. Clin Infect Dis. 2011 March;52(6):750-770

3. Lamoth F, Cruciani M, Mengoli C, et al: Beta-glucan antigenemia assay for the diagnosis of invasive fungal infections in patients with hematological malignancies: a systematic review and meta-analysis of cohort studies from the Third European Conference on Infections in Leukemia (ECIL-3). Clin Infect Dis. 2012;54:633-643

Method Description
Describes how the test is performed and provides a method-specific reference

The Fungitell assay measures levels of (1,3)-beta-D-glucan (BDG). The assay is based upon a modification of the limulus amebocyte lysate (LAL) pathway. The Fungitell reagent is modified to eliminate factor C and, thus, to only react to BDG, through the factor G-mediated side of the pathway. BDG activates factor G, a serine protease zymogen. The activated factor G converts the inactive proclotting enzyme to the active clotting enzyme, which in turn cleaves pNA from the chromogenic peptide substrate, Boc-Leu-Gly-Arg-pNA, creating a chromophore that absorbs at 405 nm. The Fungitell kinetic assay is based upon the determination of the rate of optical density (OD) increase produced by a sample. This rate is interpreted against a standard curve to produce estimates of BDG concentration in the sample.(Package insert: Assay for [(1,3]-Beta-D-Glucan in Serum. Associates of Cape Cod Inc; 02/2011)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Sunday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

1 to 2 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

2 weeks/14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

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 Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

87449

LOINC® Information

Test Id Test Order Name Order LOINC Value
SFUNG (1, 3) Beta-D-Glucan (Fungitell), S 42176-8
Result Id Test Result Name Result LOINC Value
Result LOINC Value Tooltip
603615 Fungitell Quantitative Value 42176-8
603616 Fungitell Qualitative Result 93812-6

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports