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Test ID: SCRYP
Cryptococcus Antigen Screen, Serum

Secondary ID A test code used for billing and in test definitions created prior to November 2011

86167

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

Yes

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

Aiding in the diagnosis of cryptococcosis

Reflex Tests Lists test(s) that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial test(s)

Test IDReporting NameAvailable SeparatelyAlways Performed
SCRYRCryptococcus Ag, SNoNo

Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.

If EIA results are reactive, latex agglutination testing (Cryptococcus Ag) will be performed at an additional charge.

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

SCRYP/86167: Enzyme Immunoassay (EIA)

SCRYR/28071: Latex Agglutination

Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name

Cryptococcus Ag Screen, S

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

Cryptococcus Ag Screen, S

Specimen Type Describes the specimen type needed for testing

Serum

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: 

Preferred: Red top

Acceptable: Serum gel

Specimen Volume: 1 mL

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.

0.5 mL

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

Hemolysis

Mild OK; Gross reject

Lipemia

Mild OK; Gross reject

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 TypeTemperatureTime
SerumRefrigerated (preferred)14 days
 Frozen 14 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 (serum or cerebrospinal fluid [CSF]) is indicative of cryptococcosis. Specimens that are positive or equivocal by EIA are automatically reflexed to a latex agglutination (LA) test for confirmation. The LA assay will detect cryptococcal antigen in serum specimens in most cases of CNS or disseminated disease. In addition, the LA assay will detect the antigen in approximately 30% of infected patients who are asymptomatic. Disseminated infection is usually accompanied by a positive serum test.

 

Higher titers appear to correlate with more severe infections. Declining titers may indicate regression of infection. 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, as measured by smear and culture.

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

The cryptococcal antigen test is less frequently positive in serum than in CSF.

 

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

 

A positive result is indicative of cryptococcosis; however, all test results should be reviewed in light of other clinical data.

 

Patients having trichosporonosis may yield false-positive results.

 

Rheumatoid factor may produce false-positive results.

Clinical Reference Provides recommendations for further in-depth reading of a clinical nature

1. Warren NG, Hazen KC: Candida, Cryptococcus, and other yeasts of medical importance. In Manual of Clinical Microbiology. Seventh edition. Edited by PR Murray. Washington, DC, ASM Press, 1999, pp 1184-1199

2. Lu H, Zhou Y, Yin Y, et al: Cryptococcal antigen test revisited: significance for cryptococcal meningitis therapy monitoring in a tertiary Chinese hospital. J Clin Microbiol 2005 June;43(6):2989-2990

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

The cryptococcal antigen EIA utilizes anticryptococcal, polyclonal antibodies adsorbed to microwells; and a detection system based upon a monoclonal-peroxidase conjugate (cryptococcal antigen-specific monoclonal antibody conjugated to horseradish peroxidase in buffered protein solution). If cryptococcal antigens are present in the sample, a complex is formed between the antigens, enzyme conjugate, and the adsorbed antibody. After washing to remove unbound conjugate, a substrate solution is added. Color develops in the presence of bound enzyme. The amount of color is related to the quantity of cryptococcal antigen present. (Package insert: Premier Cryptococcal Antigen, Meridian Bioscience, Cincinnati, OH)

 

Reflex Test:

The latex agglutination 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, Inc., Cincinnati, Ohio 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 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. Pronase treatment of the specimen serves to reduce false-positive test results. (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 Friday; 11 a.m., Saturday, Sunday; 1 p.m.

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.

Same day/1 day

Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result

2 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 The location of the laboratory that performs the test

Rochester

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.

This test has been cleared or approved by the U.S. 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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

87327-Cryptococcus EIA

86403-Cryptococcus latex agglutination (if appropriate)

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 IDReporting NameLOINC Code
SCRYPCryptococcus Ag Screen, S29903-2