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Calprotectin ELISA Assay



NovaTec Immundiagnostica GmbH, together with CALPRO, has developed a new Calprotectin ELISA kit, which has the broadest assay range on the market. It gives accurate results from 25 - 2500 mg/kg with only one dilution of faecal extracts:

  • Reliable tool to differentiate between IBD and IBS
  • Assessment of iflammation activity in IBD
  • Monitoring response to treatment in IDB
  • Assessment of mucosal bealing in IBD
  • Predictor of relapses in IBD

The assay has been validated by leading European clinics and laboratories. It has also been validated for testing plasma/serum samples, enabling among others assessment of rheumatic diseases and distinction between bacterial and viral infections.

The Calprotectin test emerges as a routine follow-up method for IBD patients like blood glucose for diabetics. Faecal calprotectin can detect smouldering inflammation that might be treated and change the course of the disease.

The incidence of inflammatory bowel disease is on the increase in both adults and children. The disorder includes two major forms of chronic intestinal inflammation: Crohn?s disease and ulcerative colitis. Suspicion is raised in patients with persistent (≥4 weeks) or recurrent (≥2 episodes in six months) abdominal pain and diarrhoea.

Additionally, rectal bleeding, weight loss, or anaemia increase the probability of the condition. Pathognomonic signs or symptoms do not exist. Endoscopic evaluation with histopathological sampling are generally considered indispensable in the investigation of patients with suspected inflammatory bowel disease.

Many patients consider endoscopy and the required bowel preparation to be uncomfortable. In a relatively large proportion of people with suspected inflammatory bowel disease the results of endoscopy will be negative. A third of adults with bleeding related symptoms have no abnormalities on endoscopy, and this proportion increases to half with non-bleeding symptoms such as diarrhoea, abdominal pain, and weight loss.

Identification of low risk patients would reduce the number of unnecessary invasive endoscopic procedures. Conversely, doctors would like to be able to identify those with a sufficiently high likelihood of inflammatory bowel disease to justify urgency for endoscopy.Use of a simple, non-invasive, and cheap screening test to make a presumptive diagnosis of inflammatory bowel disease would help to reach these goals.

Determination of Calprotectin levels in stools could be a good screening method. Calprotectin is a major protein found in the cytosol of inflammatory cells. The protein is stable in stool samples for up to seven days at room temperature and one sample of less than 5 g is sufficient for a reliable measurement. These qualities allow for stool sample collection at home and potential delays in transport to the laboratory.

Since 2000, faecal calprotectin has been evaluated in numerous diagnostic studies in both adult and paediatric populations. Many of these studies included healthy people on one side of the patient spectrum and patients with known inflammatory bowel disease on the other. Both extremes give cause to overestimation of diagnostic accuracy relative to the practical situa- tion, where screening is necessary because it is difficult to clinically distinguish between those who do and those who do not need urgent endoscopy. The doctor is then left with little guidance about the usefulness of faecal calprotectin as a screening test. We carried out a meta-analysis to evaluate whether adding faecal calprotectin testing to the investigation of patients with suspected inflammatory bowel disease reduced the number of unnecessary endoscopies.

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