Test Catalog

Test Id : CALPR

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Calprotectin, Feces

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Overview

Test Catalog

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

Evaluation of patients suspected of having a gastrointestinal inflammatory process

 

Distinguishing inflammatory bowel disease from irritable bowel syndrome, when used in conjunction with other diagnostic modalities, including endoscopy, histology, and imaging

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

Calprotectin, F

Specimen Type
Describes the specimen type validated for testing

Fecal

Shipping Instructions

Preferred shipping temperature is frozen. Refrigerated or thawed specimens received more than 72 hours postcollection will be rejected.

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

Supplies: Stool container, Small (Random), 4 oz Random (T288)

Submission Container/Tube: Stool container

Specimen Volume: 5 g

Collection Instructions:

1. Collect a fresh random fecal specimen, no preservative.

2. If specimen is sent refrigerate, send immediately after collection.

3. If specimen cannot be sent immediately, freeze specimen and send frozen.

Additional Information:

1. Separate specimens must be submitted when multiple tests are ordered. Specimen must be split prior to transport.

2. Testing cannot be added on to a previously collected specimen.

Forms

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

-General Request (T239)

-Gastroenterology and Hepatology Client Test Request (T728)

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

Specimens collected from diapers 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 Frozen (preferred) 7 days
Refrigerated 72 hours

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

Evaluation of patients suspected of having a gastrointestinal inflammatory process

 

Distinguishing inflammatory bowel disease from irritable bowel syndrome, when used in conjunction with other diagnostic modalities, including endoscopy, histology, and imaging

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

Calprotectin, formed as a heterodimer of S100A8 and S100A9, is a member of the S100 calcium-binding protein family. It is expressed primarily by granulocytes and, to a lesser degree, by monocytes/macrophages and epithelial cells. In neutrophils, calprotectin comprises almost 60% of the total cytoplasmic protein content. Activation of the intestinal immune system leads to recruitment of cells from the innate immune system, including neutrophils. The neutrophils are then activated, which leads to release of cellular proteins, including calprotectin. Calprotectin is eventually translocated across the epithelial barrier and enters the lumen of the gut. As the inflammatory process progresses, the released calprotectin is absorbed by fecal material before it is excreted from the body. The amount of calprotectin present in the feces is proportional to the number of neutrophils within the gastrointestinal mucosa and can be used as an indirect marker of intestinal inflammation.

 

Calprotectin is most frequently used as part of the diagnostic evaluation of patients with suspected inflammatory bowel disease (IBD). Patients with IBD may be diagnosed with Crohn disease or ulcerative colitis. Although distinct in their pathology and clinical manifestations, both are associated with significant intestinal inflammation. Elevated concentrations of fecal calprotectin may be useful in distinguishing IBD from functional gastrointestinal disorders, such as irritable bowel syndrome. When used for this differential diagnosis, fecal calprotectin has sensitivity and specificity both of approximately 85%. However, it must be remembered that increases in fecal calprotectin are not diagnostic for IBD, as other disorders such as celiac disease, colorectal cancer, and gastrointestinal infections, may also be associated with neutrophilic inflammation.

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.

<50.0 mcg/g (Normal)

50.0-120 mcg/g (Borderline)

>120 mcg/g (Abnormal)

 

Reference values apply to all ages.

Interpretation
Provides information to assist in interpretation of the test results

Calprotectin concentrations below 50.0 mcg/g are not suggestive of an active inflammatory process within the gastrointestinal system. For patients experiencing gastrointestinal symptoms, consider further evaluation for functional gastrointestinal disorders.

 

Calprotectin concentrations between 50.0 and 120 mcg/g are borderline and may represent a mild inflammatory process, such as in treated inflammatory bowel disease (IBD) or associated with nonsteroidal anti-inflammatory drug or aspirin usage. For patients with clinical symptoms suggestive of IBD, retesting in 4 to 6 weeks may be indicated.

 

Calprotectin concentrations above 120 mcg/g are suggestive of an active inflammatory process within the gastrointestinal system. Additional diagnostic testing to determine the etiology of the inflammation is suggested.

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

Elevations in fecal calprotectin are not diagnostic for inflammatory bowel disease (IBD), and normal fecal calprotectin concentrations do not exclude the possibility of IBD. Diagnosis of IBD should be based on clinical evaluation, endoscopy, histology, and imaging studies.

 

Borderline results in fecal calprotectin may be observed in patients taking nonsteroidal anti-inflammatory drugs, aspirin, or proton-pump inhibitors.

 

For borderline results, repeat testing in 4 to 6 weeks is suggested.

 

Elevations in fecal calprotectin may be observed in other disease states associated with neutrophilic inflammation of the gastrointestinal system, including celiac disease, colorectal cancer, and gastrointestinal infections.

 

Falsely decreased concentrations of fecal calprotectin may be observed in patients with neutropenia or granulocytopenia.

 

Due to the lack of homogenous distribution of calprotectin in fecal material, variability in results may be seen when patients are monitored over time, particularly in samples with high calprotectin concentrations.

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

1. Gisbert JP, McNicholl AG: Questions and answers on the role of faecal calprotectin as a biological marker in inflammatory bowel disease. Digest Liver Dis. 2009 Jan;41(1):56-66

2. Campeotto F, Butel MJ, Kalach N, et al: High faecal calprotectin concentrations in newborn infants. Arch Dis Child-Fetal. 2004 Jul;89(4):F353-F355

3. Dabritz J, Musci J, Foell D: Diagnostic utility of faecal biomarkers in patients with irritable bowel syndrome. World J Gastroentero. 2014 Jan 14;20(2):363-375

4. Fagerberg, UL, Loof L, Merzoug RD, et al: Fecal calprotectin levels in healthy children studied with an improved assay. J Pediatr Gastr Nutr. 2003 Oct;37(4):438-472

5. Sherwood RA, Walsham NE, Bjarnason I: Gastric, pancreatic, and intestinal function. In: Rifai N, Horwath AR, Wittwer CT, eds. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 6th ed. Elsevier; 2018:1398-1420

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

The QUANTA Lite Calprotectin Extended Range assay is an enzyme-linked immunosorbent assay (ELISA). Briefly, polyclonal capture antibodies specific for human calprotectin are immobilized on a 96-well plate. Calibrators, controls, and diluted patient samples are added to the wells of the plate. If present, calprotectin will bind to the capture antibodies on the plate. After a wash step, a solution containing an enzyme-labelled antibody is added. After another wash step, a substrate solution that will change color in the presence of the enzyme is added. The absorbance of the color produced is proportional to the amount of calprotectin in the patient sample. Lastly, the control and patient results are calculated based on a curve generated from the kit calibrators.(Packet insert: QUANTA Lite Calprotectin Extended Range ELISA kit. INOVA Diagnostics; 04/2019)

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.

3 to 5 days

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

Extracted feces: 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 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.

83993

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
CALPR Calprotectin, F 38445-3
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.
CALPR Calprotectin, F 38445-3

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

Test Update Resources

Change Type Effective Date
Test Changes - Reference Value 2021-12-16