Mobile Site ›
Normal View

Test ID: CRYPS
Cryptosporidium Antigen, Feces

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

80335

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

Establishing the diagnosis of intestinal cryptosporidiosis

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

See Parasitic Investigation of Stool Specimens Algorithm in Special Instructions for other diagnostic tests that may be of value in evaluating patients with diarrhea.

Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test

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

Enzyme-Linked Immunosorbent Assay (ELISA)

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

Cryptosporidium Ag, F

Specimen Type Describes the specimen type needed for testing

Fecal

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.

Forms: If not ordering electronically, submit a Microbiology Request Form (Supply T244) with the specimen.

 

Submit only 1 of the following specimens:

Preserved Stool

Container/Tube:

Preferred: Stool container with 10% buffered formalin preservative (Supply T466)

Acceptable: SAF or MF

Specimen Volume: 5 g

Specimen Stability Information: Ambient (preferred)/Refrigerated

 

Unpreserved Stool

Container/Tube: Stool container (Supply T288)

Specimen Volume: 5 g

Collection Instructions: See Stool Collection Information Sheet in Special Instructions.

Specimen Stability Information: Frozen

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.

1 g

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

Hemolysis

NA

Lipemia

NA

Icterus

NA

Other

Grossly bloody (containing no visible stool); very mucoid stool

 

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
FecalVaries

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

Cryptosporidia are protozoa of the coccidian group which are common parasites of livestock animals and can contaminate and survive in surface water supplies.

 

Infection of humans occurs by the fecal-oral route or by ingestion of contaminated water. The exact mechanism by which the organism causes gastroenteritis is unknown.

 

Cryptosporidiosis occurs as a profuse diarrhea in patients with AIDS and as a self-limited moderate diarrhea in young children, especially daycare attendees and their relatives.

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

A positive enzyme-linked immunosorbent assay (ELISA) indicates the presence of antigens of cryptosporidium and is interpreted as evidence of infection with that organism.

 

The sensitivity, specificity, and positive predictive value of the ELISA were 87%, 99%, and 98% respectively, as determined by examination of 231 fecal specimens by conventional microscopy and by ELISA.

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

Examination of multiple fecal specimens may be required to detect Cryptosporidium.

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

Soave R, Johnson WD Jr: Cryptosporidium and Isospora belli. J Infect Dis 1988;157:225-229

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

Cryptosporidium antigens present in the fecal supernatant are captured by the antibody-coated microtiter wells. A second antibody is added which binds to the complex. This signal is amplified by the addition of antibody biotin conjugate and streptavidin peroxidase. The resulting blue color development indicates the presence of cryptosporidium antigens in the feces. The reaction is completed with acid which changes the blue to yellow and the test is read on a spectrophotometer. Enzyme-linked immunosorbent assay-positive results on stools received in fixative are confirmed by direct fluorescent assay (DFA) before reporting. Frozen stools cannot be confirmed with DFA testing. (Ungar BL: Enzyme-linked immunoassay for detection of cryptosporidium antigens in fecal specimens. J Clin Microbiol 1990;28:2491-2495; Rosenblatt JE, Sloan LM: Evaluation of an immunoassay for the detection of cryptosporidium in stool specimens. J Clin Microbiol 1993;31:1468-1472)

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 Saturday; 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

3 days

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

Until reported

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.

87328

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
24086Cryptosporidium Ag, F6371-9