Test Catalog

Test Id : ULFA

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Cryptococcus Antigen Screen, Lateral Flow Assay, Random, Urine

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Overview

Test Catalog

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

Aiding in the diagnosis of infection with Cryptococcus neoformans or Cryptococcus gattii

 

This test should not be used as a test of cure.

 

This test should not be used as a screening procedure for the general population.

Highlights

Detection of Cryptococcus antigen in urine may be used as an adjunct method for diagnosis of disseminated infection with Cryptococcus neoformans or Cryptococcus gattii alongside culture and other serologic methods (eg, Cryptococcus antigen testing on serum or cerebrospinal fluid).

 

A negative result should not be used to rule-out infection.

Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.

Test Id Reporting Name Available Separately Always Performed
ULFAT Cryptococcus Ag Titer, LFA, U No No

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

If this screen is positive, the antigen titer will be performed at an additional charge.

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

Lateral Flow Assay (LFA)

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

Cryptococcus Ag Screen, LFA, U

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

Pigeon droppings

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

If this screen is positive, the antigen titer will be performed at an additional charge.

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: Urine Tubes, 10 mL (T068)

Submission Container/Tube: Plastic, 10-mL urine tube

Specimen Volume: 1 mL

Collection Instructions:

1. Collect a random urine specimen.

2. No preservative.

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. The minimum volume is sufficient for one attempt at testing.

0.5 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 14 days

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

Aiding in the diagnosis of infection with Cryptococcus neoformans or Cryptococcus gattii

 

This test should not be used as a test of cure.

 

This test should not be used as a screening procedure for the general population.

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

If this screen is positive, the antigen titer will be performed at an additional charge.

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

Cryptococcosis is an invasive fungal infection caused by Cryptococcus neoformans or Cryptococcus gattii. The organism has been isolated from several sites in nature, particularly weathered pigeon droppings.

 

Infection is usually acquired via the pulmonary route. Patients are often unaware of any exposure history. Approximately half of the patients with symptomatic disease have a predisposing immunosuppressive condition such as AIDS, steroid therapy, lymphoma, or sarcoidosis. Symptoms may include fever, headache, dizziness, ataxia, somnolence, and cough. While the majority of C neoformans infections occur in immunocompromised patient populations, C gattii has a predilection for infection of healthy individuals.

 

In addition to the lungs, cryptococcal infections frequently involve the central nervous system (CNS), particularly in patients infected with HIV. Mortality associated with CNS cryptococcosis approaches 25% despite antifungal therapy, while untreated CNS cryptococcosis is invariably fatal. Disseminated disease may affect any organ system and usually occurs in immunosuppressed individuals.

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

Reference values apply to all ages.

Interpretation
Provides information to assist in interpretation of the test results

The presence of cryptococcal antigen (CrAg) in any body fluid is strongly suggestive of infection with Cryptococcus neoformans or Cryptococcus gattii.

 

Declining titer results are suggestive of clinical response to therapy. However, monitoring CrAg titers should not be used as a test of cure, as low-level titers may persist for extended periods of time following appropriate therapy and disease resolution.

 

In addition to testing for CrAg, patients with presumed disease due to C neoformans or C gattii should have appropriate clinical specimens (eg, blood, bronchoalveolar lavage fluid) submitted for routine smear and fungal culture.

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

A negative result does not preclude the diagnosis of cryptococcosis, particularly if only a single specimen has been tested and the patient shows symptoms consistent with cryptococcal infection.

 

A positive result is suggestive of cryptococcosis; however, all test results should be interpreted considering other clinical findings.

 

Testing should not be performed as a screening procedure for the general population and should only be performed when clinical evidence suggests the cryptococcal disease.

 

Although rare, extremely high concentrations of cryptococcal antigen (CrAg) can result in weak-positive or false-negative results.

 

Patients with trichosporonosis or Capnocytophaga species infection may yield false-positive results.

 

If followed for clinical purposes, CrAg titers should be followed using the same assay.

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

1. Hazen KC, Howell SA: Candida, Cryptococcus, and other yeasts of medical importance. In: Murray PR, ed. Manual of Clinical Microbiology. 9th ed. ASM Press; 2007:1762-1788

2. Bruner KT, Franco-Paredes C, Henao-Martinez A, et al: Cryptococcus gattii complex infections in HIV-infected patients, Southeastern United States. EID. 2018 Nov;24(11):1998-2002. doi: 10.3201/eid2411.180787

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

The Cryptococcus antigen (CrAg) lateral flow assay is a sandwich immunochromatographic assay. Specimens and diluent are added to a test tube, and the lateral flow device is added. The test uses specimen wicking to capture gold-conjugated anti-cryptococcal antigen monoclonal antibodies and gold-conjugated control antibodies deposited on the test membrane. If cryptococcal antigen is present in the specimen, it binds to the gold-conjugated anti-cryptococcal antigen antibodies. This complex wicks up the membrane and interacts with the test line, which has immobilized anti-cryptococcal antigen monoclonal antibodies. The antigen-antibody complex forms a sandwich at the test line causing a visible line to form. A valid test shows a visible line at the control line. Positive test results create 2 lines (control and specimen), while negative results form only the control line.(Package insert: CrAg Lateral Flow Assay. IMMY; Rev 06/27/2019)

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 Friday

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 4 days

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

7 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 account representative. 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 modified from the manufacturer's instructions. Its performance characteristics were 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.

87899

87899 (if appropriate)

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
ULFA Cryptococcus Ag Screen, LFA, U 16693-4
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.
604095 Cryptococcus Ag Screen, LFA, U 16693-4

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