Test Catalog

Test Id : UBLAS

Blastomyces Antigen, Quantitative, Enzyme Immunoassay, Random, Urine

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

Diagnosis of infection with Blastomyces dermatitidis

 

Monitor antigen levels following initiation of antifungal treatment

Highlights

Alongside other routine methods including culture, molecular testing, and serology, this test aids in the diagnosis of infection with Blastomyces dermatitidis.

 

Sensitivity for detection of antigen released from other species of Blastomyces is unknown.

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

Enzyme Immunoassay (EIA)

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

Blastomyces Ag, Quant EIA, U

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

UBLAS

Blastomyces dermatitidis urinary antigen

Specimen Type
Describes the specimen type validated for testing

Urine

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

Supplies: Aliquot tube, 5 mL (T465)

Container/Tube: Plastic vial

Specimen Volume: 4 mL

Collection Instructions:

1. Collect a random urine specimen.

2. No preservative.

3. Do not centrifuge to remove particulates.

Forms

If not ordering electronically, complete, print, and send Infectious Disease Serology Test Request (T916) with the specimen.

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

2.5 mL

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

Gross hemolysis Reject
Turbid
Colored
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
Urine Refrigerated (preferred) 14 days
Frozen 28 days
Ambient 7 days

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

Diagnosis of infection with Blastomyces dermatitidis

 

Monitor antigen levels following initiation of antifungal treatment

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

Blastomyces dermatitidis is endemic throughout the Midwestern, south central, and Southeastern United States, particularly in regions around the Ohio and Mississippi river valleys, the Great Lakes, and the Saint Lawrence River. It is also found in regions of Canada. Blastomyces species are dimorphic fungi, preferring moist soil and decomposing organic matter, which produces fungal spores that are released and inhaled by humans. At body temperature, spores mature into yeast, which may remain in the lungs or disseminate through the bloodstream to other parts of the body. Through phylogenetic analysis, B. dermatitidis has been separated into 2 distinct species: B dermatitidis and Blastomyces gilchristii, both able to cause blastomycosis. B dermatitidis infections are frequently associated with dissemination, particularly in older patients, smokers, and immunocompromised hosts, while B gilchristii has primarily been associated with pulmonary and constitutional symptoms. Additional species of Blastomyces have recently been discovered and characterized, however the performance characteristics of this assay for these species are unknown.

 

Approximately half of patients infected with Blastomyces will develop symptoms, which are frequently nonspecific, including fever, cough, night sweats, myalgia or arthralgia, weight loss, dyspnea, chest pain, and fatigue. Symptoms may appear anywhere from 3 weeks to 3 months following infection. Diagnosis of blastomycosis relies on a combination of assays, including culture and molecular testing performed on appropriate specimens, and serologic evaluation for both antibodies to and antigen released from Blastomyces. Although culture remains the gold standard method and is highly specific, the organism can take several days to weeks to grow and sensitivity is diminished in cases of acute or localized disease. Similarly, molecular testing offers high specificity and a rapid turnaround time, however sensitivity is imperfect. Detection of an antibody response to Blastomyces offers high specificity, however results may be falsely negative in patients who are acutely ill or are immunosuppressed.

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.

BLASTOMYCES ANTIGEN RESULT

Not detected

 

BLASTOMYCES ANTIGEN VALUE

Not detected: 0.0 ng/mL

Detected: <1.3 ng/mL

Detected: 1.3-20.0 ng/mL

Detected: >20.0 ng/mL

Interpretation
Provides information to assist in interpretation of the test results

Not Detected: No Blastomyces antigen detected. False negative results may occur. Repeat testing on a new specimen should be considered if clinically indicated.

 

Detected: Blastomyces antigen detected, below the limit of quantification (<1.3 ng/mL). Results should be correlated with clinical presentation, exposure history, and other diagnostic procedures, including culture, serology, histopathology, and radiographic findings, for the diagnosis of blastomycosis. False-positive results may occur in patients with other fungal infections, including Histoplasma.

 

Detected: Blastomyces antigen detected. The reportable range of this assay is 1.3 to 20.0 ng/mL. Results should be correlated with clinical presentation, exposure history, and other diagnostic procedures, including culture, serology, histopathology, and radiographic findings, for the diagnosis of blastomycosis. False-positive results may occur in patients with other fungal infections, including Histoplasma.

 

Detected: Blastomyces antigen detected, above the limit of quantification (>20.0 ng/mL). Results should be correlated with clinical presentation, exposure history, and other diagnostic procedures, including culture, serology, histopathology, and radiographic findings, for the diagnosis of blastomycosis. False-positive results may occur in patients with other fungal infections, including Histoplasma.

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

Cross-reactivity with other fungal infections, including Histoplasma capsulatum, may occur. Positive results should be correlated with other clinical and laboratory findings (eg, culture, serology).

 

Low-level positive antigen levels may persist following resolution of infection and completion of appropriate treatment regimen.

 

Turbid urine specimens, containing excess protein, cells, or particulate matter, can inhibit the function of the test.

 

Sensitivity of this assay to detect antigen from species other than Blastomyces dermatitidis is unknown.

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

1. McBride JA, Gauthier GM, Klein BS: Clinical manifestations and treatment of Blastomycosis. Clin Chest Med. 2017 Sep;38(3):435-449

2. Saccente M, Woods GL: Clinical and laboratory update on Blastomycosis. Clin Microbiol Rev. 2010 Apr;23(2):367-381. doi: 10.1128/CMR.00056-09

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

The assay detects Blastomyces dermatitidis antigen shed in human urine samples using specific, proprietary antibodies in an enzyme-linked immunosorbent assay format. The detection method involves an enzyme/substrate system with the level of urinary B dermatitidis antigen proportional to the assay signal. The patient specimen result is compared to a cutoff calibrator and a standard curve of a series of assay calibrators (1.25 to 20.00 ng/mL) to determine the presence or absence of antigen, and if present, to establish a quantitative level of B dermatitidis urinary antigen.(Package insert: Blastomyces dermatitidis Urinary Antigen Detection Kit. Gotham Biotechnology; Version 001, Revision 002. 10/29/2020)

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 Saturday

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.

Same day/1 to 3 days

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

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 was developed, and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

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
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
UBLAS Blastomyces Ag, Quant EIA, U In Process
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
BLASQ Blastomyces Ag Result 41746-9
DEXBU Blastomyces Ag Value 93429-9

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