Test Definition: CALPR

Calprotectin, F
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Overview

Useful For
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
Enzyme-Linked Immunosorbent Assay (ELISA)

NY State Available
Yes

Specimen

Specimen Type
Fecal
Shipping Instructions
Preferred shipping temperature is frozen. Refrigerated or thawed specimens received more than 72 hours postcollection
will be rejected.

Specimen Required
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 and send frozen (preferred).
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)

Reject Due To

Specimens collected from diapers Reject

Specimen Minimum Volume

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 Test Definition: CALPR
Calprotectin, F
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1g

Specimen Stability Information

Specimen Type Temperature Time Special Container

Fecal Frozen (preferred) 7 days
Refrigerated

Clinical & Interpretive

Clinical Information
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
< 50.0 mcg/g (Normal)
50.0-120 mcg/g (Borderline)
> 120 mcg/g (Abnormal)
Reference values apply to all ages.

Interpretation
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.

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 Test Definition: CALPR
Calprotectin, F
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Cautions
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
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

Performance

Method Description
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
No

Specimen Retention Time

7 days; extracted feces only, the submitted specimen is discarded after processing

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Calprotectin, F
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Performing Laboratory Location
Rochester

Fees & Codes

Test Classification
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

83993

LOINC® Information

Test ID Test Order Name Order LOINC Value

CALPR Calprotectin, F 38445-3

Result ID Test Result Name Result LOINC Value

CALPR Calprotectin, F 38445-3

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