EliA Calprotectin The first fully automated calprotectin stool test

1. EliA CalprotectinThe first fully automated calprotectin stool test

2. What is calprotectin? • Calprotectin is a calcium- and zinc-binding proteinhaving many different functions in the cell. • It is a major part of the cytoplasm of neutrophil granulocytes, monocytes and epithelial cells, and makes up to 60% of the soluble ingredients of neutrophil granulocytes.1

3. Why does calprotectin occur in the stool? • In inflammation, the leukocytes migrate through the intestinal wall, leading to increased calprotectin level in the stool. • The concentration of calprotectin correlates with the number of granulocytes in the intestinal lumen, and thus with the level of intestinal inflammation.1

4. What is the disease association of calprotectin? • Calprotectin in stool specifically indicates intestinal inflammation and is elevated in inflammatory bowel diseases (IBD). • The most frequent IBD are Crohn‘s disease and ulcerative colitis. • Fecal calprotectin levels are normal in non-inflammatory intestinal disorders, such as irritable bowel syndrome (IBS) and other functional bowel diseases (e.g. infections, lactose intolerance, food allergy, etc.) Crohn‘s disease Ulcerative colitis

5. What is the use of detecting fecal calprotectin? • Fecal calprotectin is able to provide early diagnostic guidance by differentiating between inflammatory bowel diseases (IBD, such as Crohn’s disease or ulcerative colitis) and non-inflammatory functional bowel diseases, e.g. irritable bowel syndrome (IBS).5 • As first line test a negative result can rule out an inflammatory process while a positive result may prioritize endoscopy in the diagnostic path.2 • Fecal calprotectin is an efficient marker for therapeutic effectiveness and mucosal healing since its level correlates well with endoscopic and histological findings in inflammatory bowel diseases.3,4 • Recent studies show that rising fecal calprotectin levels can predict relapse in Crohn‘s disease and ulcerative colitis.5,6,7

6. What is the advantage of fecal calprotectin compared toother inflammation markers? • Fecalcalprotectinoutperformsmarkersforgeneralinflammation, such as C-reactiveprotein (CRP) orerythrocytesedimentation rate (ESR).6 • The ROCanalysisbelowhowsthatcalprotectinisbothmore sensitive forCrohn‘sdiseaseandmorespecificthanCRPand ESR. Graph modified after TibbleAJ et al. (2000). Gastroenterology 119: 15-22

7. Why EliA Calprotectin? ► It‘s automated! • EliA Calprotectin is the first fully automated fecal calprotectin test on the market and runs on Phadia 100, 250, 2500 and 5000. • This saves costs by reducing the workload for your personnel. • Operational costs are minimized and planning simplified – leading to an optimized workflow, helping the lab to improve service quality. • Errors are minimized by easy handling and the automated process. • No batching of samples required thanks to flexibility of the instruments. Phadia 100 Phadia 250 Phadia 2500 Phadia 5000

8. Why EliA Calprotectin? ► Early diagnostic guidance! • An internal study using samples from 132 patients with IBD and 59 samples from patients with IBS and other functional bowel disorders shows that EliA Calprotectin has very high predictive values, providing early diagnostic guidance for the physician.

9. Why EliA Calprotectin? ► Results of high clinical value! • The excellent likelihood ratios for EliA Calprotectin demonstrate its capability to both rule out IBD or identify IBD.

10. Why EliA Calprotectin? ► Better than competition! • The two most important competitors were included in the clinical study. EliA Calprotectin turns out to be the best test, and it‘s automated!

11. Why EliA Calprotectin? ► Combine tests as you like! • On Phadia Laboratory Systems EliA Calprotectin can be run together with a broad panel of other EliA tests used for differential diagnosis of gastrointestinal disorders, such as EliA Celikey (IgA and IgG) and EliA GliadinDP (IgA and IgG), even in the same run. • On Phadia 250, 2500 and 5000 EliA Calprotectin can even be combined with tests for food allergy in the same run. • This possibility of test combination offers comprehensive diagnostic testing for differential diagnosis of gastrointestinal disorders.

12. References 1 Vermeire S et al. (2006). Laboratory markers in IBD: Useful, magic or unnecessary toys? Gut 55: 426-431 2 Summerton CB et al (2002). Faecal calprotectin: a marker of inflammation throughout the intestinal tract. Eur J Gastroenterol Hepatol 14: 841-845 3 Roseth AG et al (2004). Normalization of faecal calprotectin: a predictor of mucosal healing in patients with inflammatoy bowel disease. Scand J Gastroenterol 39: 1017-1020 4 Roseth AG et al (1997). Assessment of disease activity in ulcerative colitis by faecal calprotectin, a novel granulocyte marker protein. Digestion 58: 176-180 5 Sutherland AD et al (2008). Review of fecal biomarkers in inflammatoy bowel disease.Dis Colon Rectum 51: 1283-1291 6 Tibble JA et al (2000). Surrogate markers of intestinal inflammation are predictive of relapse in patients with inflammatroy bowel disease. Gastroenterology 119: 15-22 7 D‘Inca R et al (2005). Can Calprotectin predict relapse in inflammatoy bowel disease? Gastroenterology 128 (suppl): A307

13. EliACalprotectin Identify IBD. Clearlyandefficiently.