Test ID: CRYPU
Cryptococcus Antigen, Urine
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Useful For Suggests clinical disorders or settings where the test may be helpful
Aiding in the diagnosis of cryptococcosis
Method Name A short description of the method used to perform the test
Latex Agglutination
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
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.
Container/Tube: Plastic, 10-mL urine tube (Supply T068)
Specimen Volume: 0.5 mL
Collection Instructions:
1. Collect a random urine specimen.
2. No preservative.
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.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | NA |
| Lipemia | NA |
| Icterus | NA |
| Other | NA |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Urine | Refrigerated (preferred) | 7 days |
| Frozen | 7 days |
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. 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.
In addition to the lungs, cryptococcal infections frequently involve the central nervous system (CNS), particularly in patients infected with HIV. Mortality in CNS cryptococcosis may approach 25% despite antibiotic therapy. 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
Interpretation Provides information to assist in interpretation of the test results
The presence of cryptococcal antigen in any body fluid is indicative of cryptococcosis.
Higher titers appear to correlate with more severe infections. Declining titers in urine or serum may indicate regression of infection or response to therapy. However, monitoring titers to cryptococcal antigen should not be used as a test of cure, as low level titers may persist for extended periods of time following appropriate therapy and the resolution of infection.
In addition to testing for cryptococcal antigen, patients with presumed disease due to Cryptococcus neoformans should have clinical specimens (eg, 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 cryptococcosis.
Patients having trichosporonosis may yield false-positive results.
Rheumatoid factor may produce false-positive results.
Supportive Data
Thirty analyte-negative urine specimens were spiked with a positive control specimen (purified cryptococcal antigen derived from a culture isolate of Cryptococcus neoformans to yield a desired endpoint titer of 1:16 (10 specimens), 1:64 (10 specimens) or 1:512 (10 specimens). These specimens were then tested by the Cryptococcal Antigen Latex Agglutination System (CALAS; Meridian Bioscience, Cincinnati, OH) and all samples yielded the expected endpoint titer (one, 2-fold serial dilution).
To assess analytical specificity, urine specimens previously shown to be positive for Histoplasma (n=6) or Blastomyces (n=1) antigen were tested by the CALAS assay. In addition, analyte-negative urine samples (n=16) spiked with Aspergillus antigen control material were tested. All specimens (23/23=100%) containing potentially cross-reactive fungal antigen were negative by the CALAS assay.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
Hazen KC, Howell SA: Candida, Cryptococcus, and other Yeasts of Medical Importance. In Manual of Clinical Microbiology. 9th edition. Edited by PR Murray. Washington, DC, ASM Press, 2007, pp 1762-1788
Method Description Describes how the test is performed and provides a method-specific reference
The test for cryptococcal antigen uses latex particles sensitized with rabbit anticryptococcal globulins to detect circulating antigen of Cryptococcus neoformans (CALAS Cryptococcal Antigen Latex Agglutination System, Meridian Diagnostics, Cincinnati OH 45244). When the anticryptococcal globulin-sensitized latex particles come in contact with the polysaccharide antigen of Cryptococcus neoformans in the specimen, agglutination occurs. Specimens are tested at dilutions of undiluted, 1:2, 1:4, 1:8, etc. A drop of detection latex is mixed with the specimen on a slide and rotated for 5 minutes at 125 rpm. The highest titer producing a 2+ or greater reaction is reported. (Stockman L, Roberts GD: Specificity of the latex test for cryptococcal antigen: a rapid simple method for eliminating interference factors. J Clin Microbiol 1982;16:965-967)
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 Sunday; Variable
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
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
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.
86403
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 |
|---|---|---|
| 60319 | Cryptococcus Ag, Urine | 43228-6 |
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