Test Catalog

Test Id : CRYPS

Cryptosporidium Antigen, Feces

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

Establishing the diagnosis of intestinal cryptosporidiosis

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

For other diagnostic tests that may be of value in evaluating patients with diarrhea; the following algorithms are available:

-Parasitic Investigation of Stool Specimens Algorithm

-Laboratory Testing for Infectious Causes of Diarrhea

Special Instructions
Library of PDFs including pertinent information and forms related to the test

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

Enzyme-Linked Immunosorbent Assay (ELISA)

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

Cryptosporidium Ag, F

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

For other diagnostic tests that may be of value in evaluating patients with diarrhea; the following algorithms are available:

-Parasitic Investigation of Stool Specimens Algorithm

-Laboratory Testing for Infectious Causes of Diarrhea

Specimen Type
Describes the specimen type validated for testing

Fecal

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

Submit only 1 of the following specimens:

 

Specimen Type: Preserved feces

Supplies:

-Formalin 10% Buffered Neutral 15 mL (T466)

-Stool Collection Kit, Random (T635)

Container/Tube:

Preferred: Stool container with 10% buffered formalin preservative

Acceptable: SAF (sodium acetate formalin)

Specimen Volume: 5 g

Specimen Stability Information: Ambient (preferred) 60 days

 

Specimen Type: Unpreserved feces

Supplies:

-Stool container, Small (Random), 4 oz (T288)

-Stool Collection Kit, Random (T635)

Container/Tube: Stool container

Specimen Volume: 5 g

Specimen Stability Information: Frozen 60 days

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Forms

If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

-Gastroenterology and Hepatology Client Test Request (T728)

-Microbiology Test Request (T244)

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

1 g

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

Grossly bloody (containing no visible feces)
Very mucoid feces
Colonic wash
ECOFIX (green cap)
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
Fecal Varies

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

Establishing the diagnosis of intestinal cryptosporidiosis

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

For other diagnostic tests that may be of value in evaluating patients with diarrhea; the following algorithms are available:

-Parasitic Investigation of Stool Specimens Algorithm

-Laboratory Testing for Infectious Causes of Diarrhea

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

Cryptosporidia are small apicomplexan protozoan parasites that infect the intestinal tract of humans and animals. They were conventionally categorized as coccidia but are now known to be more closely related to the gregarines. Many species may infect humans, with the most common being Cryptosporidium hominis and Cryptosporidium parvum. Infected humans and animals shed small (4-6 micrometer in diameter) infectious oocysts in their stool, and these can subsequently contaminate and survive in recreational and drinking water supplies.

 

Infection of humans occurs by the fecal-oral route or via ingestion of contaminated water or food. Infection is easily acquired, with an infectious dose of approximately 100 oocysts. Waterborne transmission is a primary mode of transmission and is commonly responsible for human outbreaks. This is because Cryptosporidium species oocysts are resistant to cold temperatures and chlorine and require extensive filtration or water treatment to remove them from drinking water.

 

The incubation period is typically 7 to 10 days following exposure. While most patients have symptoms, approximately 30% of infected individuals are asymptomatic. When symptoms are present, they usually include profuse watery diarrhea, malaise, anorexia, nausea, crampy abdominal pain, and low-grade fever. Infection is usually self-limited in immunocompetent individuals, with resolution of symptoms in 10 to 14 days. However, diarrhea can be prolonged and life-threatening in immunocompromised patients such as those with AIDS, infants, and older adults, and result in severe dehydration and wasting.

 

The fecal ova and parasite examination is an insensitive method for detecting Cryptosporidium, given the small size of the oocysts and their lack of trichrome staining. Instead, use of this test, or the multiplex gastrointestinal polymerase chain reaction (PCR) panel (GIP / Gastrointestinal Pathogen Panel, PCR, Feces), is recommended for sensitive and specific detection. This antigen test is ideal for situations in which cryptosporidiosis is highly suspected (eg, outbreak scenarios), whereas the PCR panel allows for simultaneous detection of multiple parasitic, viral, and bacterial causes of diarrhea.

 

For more information about diagnostic tests that may be of value in evaluating patients with diarrhea, see the following:

-Parasitic Investigation of Stool Specimens Algorithm

-Laboratory Testing for Infectious Causes of Diarrhea

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 result indicates the presence of antigens of cryptosporidium and is interpreted as evidence of infection with that organism.

 

Interpretation of results should be correlated with patient symptoms and clinical picture.

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

Examination of at least 2 fecal specimens may be required to detect Cryptosporidium using antigen testing.

 

Feces containing large amounts of white or red blood cells may produce false-positive results.

Supportive Data

The sensitivity, specificity, and positive and negative predictive value (PPV and NPV) of the enzyme-linked immunosorbent assay were 98%, 98%,98% PPV and 98.5% NPV, respectively, as determined by examination of 130 fecal specimens by conventional microscopy and by ELISA.

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

1. Centers for Disease Control and Prevention (CDC): Parasites-Cryptosporidium (also known as "Crypto"). CDC; Updated July 1, 2019. Accessed October 31, 2022. Available at www.cdc.gov/parasites/crypto/index.html

2. Garcia LS, Arrowood M, Kokoskin E, et al. Practical guidance for clinical microbiology laboratories: Laboratory diagnosis of parasites from the gastrointestinal tract. Clin Microbiol Rev. 2017 Nov 15;31(1):e00025-17. doi: 10.1128/CMR.00025-17

Special Instructions
Library of PDFs including pertinent information and forms related to the test

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 that 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..(Ungar BL: Enzyme-linked immunoassay for detection of cryptosporidium antigens in fecal specimens. J Clin Microbiol. 1990;28:2491-2495. doi: 10.1128/jcm.28.11.2491-2495.1990; Rosenblatt JE, Sloan LM: Evaluation of an immunoassay for the detection of cryptosporidium in stool specimens. J Clin Microbiol. 1993;31:1468-1472. doi: 10.1128/jcm.31.6.1468-1471.1993; package insert: ProSpecT Cryptosporidium Microplate Assay. Oxoid; 04/2012)

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

Fresh/Frozen: 1 week; Preserved specimens: 1 week

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 has been cleared, approved, or is exempt by the US 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 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.

87328

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
CRYPS Cryptosporidium Ag, F 6371-9
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.
24086 Cryptosporidium Ag, F 6371-9

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