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Test Code LAB1230580 Calprotectin, Feces

Important Note

Issue additional container for specimen collection if collecting multiple stool tests. Do not combine with other containers.

Clinical Information

Fecal calprotectin is a non-invasive biomarker for distinguishing inflammatory bowel disease (IBD), such Crohn’s disease (CD) or ulcerative colitis (UC), from irritable bowel syndrome (IBS) when used in conjunction with other diagnostic modalities, including endoscopy, histology, and imaging.

 

Fecal calprotectin is a calcium-and zinc-binding protein comprising 60% of the total cytoplasmic protein content of neutrophils.  In the process of inflammation, neutrophils are activated, leading to release of cellular proteins, including calprotectin.  Calprotectin translocates across the epithelial barrier, enters the lumen of the gut, and is absorbed by the fecal material.  The amount of calprotectin present in the feces is proportional to the number of neutrophils within the gastrointestinal mucosa.

 

When used for the differential diagnosis of IBD from IBS, fecal calprotectin has a sensitivity of 80% and specificity of 88% at the cut-off of 160 mcg/g.  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.

Icons & Photos

or
Stool Collection Kit - Please use the "Empty Vial"  Sterile Collection Container with Screw on Lid

 

 

Collection Instructions

Specimen Type: Stool


Container/Tube: Sterile Empty vial (white cap) of the stool specimen collection kit or sterile collection container with screw-on lid.

Volume: Fill to the line on the container
Minimum volume: 1 mL

Collection Instructions: 

  • Issue additional container for specimen collection if collecting multiple stool tests. Do not combine with other containers.
  • Be sure the cap is secured.
  • Fresh unpreserved stool is required.
  • See resources for patient collection sheet

Specimen Transport Temperature (off-site collection): Refrigerated is preferred but Ambient and Frozen are acceptable

Lab Staff Instructions

LOOK+LOOK

  • Sample can be received ambient or on a cold pack
  • Once the specimen is received in SHRL Lab Central, store the specimen in the refrigerator for pick up by the Toxicology Lab. 

Rejection Criteria

Specimens will be rejected if

  • Stool sample is visibly bloody
  • Stool collection is greater than 72 hours once received in the laboratory
  • Sample is collected in vial containing a preservative/fixative
  • Leaky specimen - Make sure all container lids are fastened evenly and securely.

Specimen Stability

Ambient: 3 days

Refrigerated: 6 days

Frozen: Acceptable

Laboratory Retention: 3 days

Test Frequency

Test performed Monday, Wednesday, Friday, with average TAT 1 - 3 days

Reference Range

<80 mcg/g (Normal)

80-160 mcg/g (Borderline)

>160 mcg/g (Abnormal)

Reference values established for ≥ 4 years old.

 

Interpretation

Fecal calprotectin concentrations <80 mcg/g are not indicative of active inflammation in the gastrointestinal tract with a negative predictive value of approximately 91%. 

 

Fecal calprotectin concentrations between 80 and 160 mcg/g are borderline and may not be directly indicative of an active inflammation.  Re-evaluation of fecal calprotectin levels after 4 to 6 weeks is recommended.

 

Fecal calprotectin concentrations >160 mcg/g are indicative of an active inflammatory process with a positive predictive value of approximately 86%.  Further diagnostic testing to determine the etiology of the inflammation is suggested.

 

Cautions/Limitations

Test results should be interpreted in conjunction with information available from clinical assessment of the patient and other diagnostic procedures.

 

Patients with IBD fluctuating between active (inflammatory) and inactive stages of the disease.  These stages must be considered when interpreting results of the fecal calprotectin assay.

 

False negative results could occur in patients who have granulocytopenia due to bone marrow depression.

 

Some patients taking non-steroidal anti-inflammatory drugs (NSAID) will have elevations in their fecal calprotectin concentrations.

 

Blood present in the sample will cause elevations in their fecal calprotectin concentrations.  Visibly bloody samples will be cancelled.

 

The following pharmaceuticals, nutritional supplements, and microorganisms may infer with accurate fecal calprotectin measurement.

 

Gyno-Tardyferon  (Iron (II) sulfate) Vitamin E (DL-α-Tocopherol Acetate)
Prednisone Bion 3 (3 probiotics)
Imurek (Azathioprine) Escherichia coli 
Salofalk (Mesalamine; 5-ASA) Salmonella enterica subsp. enterica
Agopton (Lansoprazole) Klebsiella pneumoniae subsp. Pneumoniae
Asacol   (Mesalamine; 5-ASA)

Citrobacter freundii

Vancocin (Vancomycin) Shigella flexneri
Sulfamethoxazole (Sulfamethoxazole) Yersinia enterocolitica subsp. enterocolitica
Trimethoprim (Trimethoprim lactate)  
Ciproxine (Ciprofloxacin)  

 

References

  1. Berinstein JA, Steiner CA, Bousvaros A, et al.  The Clinical Accuracy of the BÜHLMANN fCAL ELISA in the Differentiation of Inflammatory Bowel Disease From Irritable Bowel Syndrome: A Multicenter Prospective Case–Control Study. Crohn’s & Colitis 360 2019; 1(3): 1-8.
  2. Gisbert JP, McNicholl AG, Golmollon F.  Questions and answers on the role of faecal calprotectin as a biological marker in inflammatory bowel disease. Digest Liver Dis 2009;41:56-66

Performing Department

TOXICOLOGY

Performing Department Laboratory Location

Spectrum Health Regional Laboratory (SHRL LC) - Advanced Technology Laboratory (ATL), Grand Rapids, MI

Methodology

Turbidimetric

CPT

83993

CDM Code

80106036

Epic Test ID

Unavailable

Interface Order Alias

1230580

LOINC

38445-3

Mayo Access Code

SHO1230580

Reviewed Date

1/14/2020