CL0849

Fecal Human Calprotectin CLIA Kit

Description

This chemiluminescance immunoassay (CLIA) kit is intended for the quantitative determination of human calprotectin (neutrophil cytoplasmic protein A100A8/A9) levels in stool samples. This test is an aid in clinical mangement of inflammatory bowel disease (IBD) such as ulcerative colitis and Crohn's disease.
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For in-vitro diagnostic use.

Background


Calprotectin consists of mammalian proteins S100A8 and S100A9 and is a 24 kDa dimer1. It is secreted during the inflammatory response in the intestinal lumen through leukocyte shedding, active secretion, cell disturbance, and cell death7. Thus, elevated fecal calprotectin levels are correlated with migration of neutrophils into the intestinal mucosa3,4. Clinical applications may include aiding in the diagnosis of ulcerative colitis2, inflammatory bowel diseases (IBD)6, irritable bowel syndrome (IBS)8, and Crohn’s disease5.
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This CLIA is designed, developed, and produced for the quantitative measurement of human calprotectin in fecal samples. The assay utilizes a two-site “sandwich” technique with two antibodies that bind to different epitopes of calprotectin.
Assay calibrators, controls, or patient samples are added directly to a reaction vessel containing streptavidin coated magnetic particles. Simultaneously, anacridinium ester antibody and a biotin antibody are added. The magnetic particles capture the biotin antibody as well as an immuno complex in the form of “magnetic particles – biotin calprotectin antibody –calprotectin – acridinium ester calprotectin antibody”.

​​​​​​​The materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the trigger solution is added to the reaction vessel and light emision generated by the reaction is measured with the ECL100 or ECL25 automated CLIA analyzer. The relative light units (RLU) are proportional to the concentration of calprotectin in the sample. The amount of analyte in the sample is determined from a stored, multi-point calibration curve and reported in serum calprotectin concentration.

Specifications

Catalog no. CL0849
Target Calprotectin
Species Human
Method Sandwich CLIA
Tests Per Kit 100 tests
Detection Flash AE Chemiluminescence
Sensitivity / LLOD 1.60 ng/mL
Dynamic Range 0 -5000 µg/g
Total Incubation Time <25 min
Sample Type Stool
Sample Volume 75 µL
Storage Temperature 2-8 °C

Selected Literature

  1. Costa, F., Mumolo, M. G., Ceccarelli, L., Bellini, M., Romano, M. R., Sterpi, C., … Bottai, M. (2005). Calprotectin is a stronger predictive marker of relapse in ulcerative colitis than in Crohn's disease. Gut, 54(3), 364–368. doi:10.1136/gut.2004.043406
  2. Walsham, Natalie E; Sherwood, Roy A (2016). Fecal calprotectin in inflammatory bowel disease. Clinical and Experimental Gastroenterology. 9: 21–29. doi:10.2147/CEG.S51902. ISSN 1178-7023. PMC 4734737. PMID 26869808.
  3. Waugh N, Cummins E, Royle P, Kandala NB, Shyangdan D, Arasaradnam R, Clar C, Johnston R (Nov 2013). Faecal calprotectin testing for differentiating amongst inflammatory and non-inflammatory bowel diseases: systematic review and economic evaluation. Health Technol Assess (Review). 17 (55): xv–xix, 1–211. doi:10.3310/hta17550. PMC 4781415. PMID 24286461.
  4. Carmen Ribes Koninckx, et al. The use of fecal calprotectin testing in paediatric disorders: a position paper of european society for gastroenterology committee. JPGN 2021, vol 72, No 4, 617-640
For in-vitro diagnostic use.