Fecal Calprotectin (FCT)

Cost-effective, non-invasive, and sensitive biomarker for gut inflammation.

TEST OVERVIEW

Calprotectin is a protein in cells involved in inflammation, found abundantly in neutrophils. Diseases like Crohn’s disease, ulcerative colitis, and cancer cause higher faecal calprotectin excretion, but not in patients with Irritable Bowel Syndrome (IBS).

MetaMetrics Fecal Calprotectin Test (FCT) is an enzyme immunoassay intended for the quantitative assessment of calprotectin. It is a cost-effective, non-invasive, and sensitive biomarker to screen patients for intestinal inflammation.

Higher calprotectin concentration in feces indicates Inflammatory Bowel Disease (IBD) and has proven to be
a better disease activity marker on tissue biopsy than blood test markers of inflammation (e.g. white blood
cell count, ESR, and CRP).

Higher calprotectin concentration in feces indicates Inflammatory Bowel Disease (IBD) and has proven to be
a better disease activity marker on tissue biopsy than blood test markers of inflammation (e.g. white blood
cell count, ESR, and CRP).

    INTERPRETATION

  • Calprotectin concentrations of 50.0 mcg/g or lower is NEGATIVE

    This is 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 to 150.0 mcg/g is MODERATELY ELEVATED

    This may be associated with organic intestinal disease but should be interpreted in line with clinical assessment. For patients with clinical symptoms, retesting in 4 to 6 weeks may be indicated.
  • Calprotectin concentrations of 150.1 mcg/g or higher is POSITIVE

    This suggests active inflammatory process within the gastrointestinal system. Further diagnosis is advised to determine the etiology of the inflammation.

CAUTION

  • Normal fecal calprotectin DO NOT exclude the possibility of IBD, and elevated levels is NOT an outright confirmation. IBD Diagnosis should include clinical evaluation and other diagnostic modalities.
  • Borderline results in fecal calprotectin may be observed in patients taking non-steroidal anti-inflammatory drugs (NSAID), aspirin, or proton-pump inhibitors.
  • Increased fecal calprotectin may also be observed in other diseases like neutrophilic inflammation of the GI system, including celiac disease, gastrointestinal infection, and colorectal cancer
  • False decrease in fecal calprotectin concentration may be observed in patients with neutropenia or granulocytopenia.

PERFORMANCE CHARACTERISTICS

  • 100% sensitivity and 97% specificity in discriminating between Active Crohn’s Disease and Irritable Bowel Syndrome.
  • Interferences: Different substances that might interfere with MetaMetrics FCT were tested, and NO interferences with the following drugs were found: Azathioprin, Pantoprazol, Mesalazin, Clariothromycin, Levofloxacin, iron supplements, acetylsalicylic acid, Vitamin D, Gabapentin, Multivitamin preparation, or Ibuprofen.

TEST INFORMATION

  • Specimen : Stool, fill up to 1/3 of the stool container provided.
  • Method: ELISA
  • Patient Preparation: Random faecal sample (any time of day, no dietary restrictions required), collected using the provided container, and approximately 1 gram in weight. NSAID, aspirin, or PPIs may raise fecal calprotectin levels. With clearance from a medical practitioner, intake of these supplements should be stopped one week before sample collection.
  • Sample viability and storage conditions:

▸ Raw stool, viable for 2 days with refrigeration

▸ Stool extract, viable for 1 week with refrigeration

  • Turn-around Time: 7 days
  • Test Kit : Each FCT Collection Set contains a Patient Collection Kit and a Laboratory Preparation Kit

▸ 1 Patient Collection Kit contains: 1 specimen bag, 1 stool collection cup, 2 stool collection sheets, 1 piece of gloves

▸ 1 Laboratory Preparation Kit contains: 1 stool sample application system
(stool sample tube with 1.5 ml sample extraction buffer), parafilm

Reference

Utility of faecal calprotectin analysis in adult inflammatory bowel disease. Guidelines for Clinical Practice. Lyn A Smith, Daniel R
Gaya. World J Gastroenterol 2012 December 14; 18(46): 6782-6789 ISSN 1007-9327

Faecal calprotectin for screening of patients with suspected inflammatory bowel disease: diagnostic meta-analysis. Patrick F van
Rheenen,1 Els Van de Vijver,1 Vaclav Fidler. BMJ 2010;341:c3369 doi:10.1136/bmj.c3369

Food Agriculture Organization. (n.d.) Chapter 7. Vitamin A. Retrieved from http://www.fao.org/docrep/004/y2809e/y2809e0d.htm

Fecal calprotectin in inflammatory bowel diseases: update and perspectives. Mancaeu et al., Clin Chem Lab Med 2017; 55(4): 474–483

IDK® Calprotectin ELISA. Gültig ab / Valid from 2019-10-04

A simple method for assessing intestinal inflammation in Chron’s disease. J. Tibble, et al., Gut 2000; 47:506–513