Human Lactoferrin •Lactoferrin is a glycoprotein secreted by mucosal membranes; it is a major protein in the secondary granules of leukocytes •During intestinal inflammation, activated leukocytes infiltrate the mucosa and lumen, increasing the level of fecal lactoferrin •Fecal lactoferrin is elevated in patients suffering from active inflammatory bowel disease (IBD) but not in persons with irritable bowel syndrome (IBD) or healthy persons Lactoferrin levels in disease Ulcerative Colitis N=71 Lactoferrin levels (ug/g wet weight) 1200 800 400 0 Crohn’s Disease N=78 Irritable Bowel Syndrome N=31 Healthy Persons N=56 Two new non-invasive tests to detect intestinal inflammation • IBD-CHEKTM – a qualitative ELISA for the clinical lab • IBD-QUIK CHEKTM – a qualitative lateral flow test for the clinical lab or physician’s office Performance Characteristics of the IBD-CHEK™ Test N=236 Total IBD-CHEKTM IBD-CHEKTM (+) (-) Crohn’s disease Active Inactive 52 26 85% 62% 15% 39% Ulcerative colitis Active Inactive 40 31 88% 52% 13% 48% Active IBS 31 0% 100% Healthy persons 56 0% 100% Clinical Results with the IBD-CHEK™ • When distinguishing active IBD from irritable bowel syndrome and healthy persons, the IBD-CHEKTM test exhibited a sensitivity of 86% and specificity of 100% • When distinguishing active Crohn’s disease from irritable bowel syndrome and healthy persons, the IBD-CHEKTM test exhibited a sensitivity of 85% and specificity of 100% IBD-CHEK™ Test • Qualitative ELISA for detecting elevated fecal lactoferrin as an indicator of intestinal inflammation • Utilizes a four-step procedure with results in 75 minutes • A valuable noninvasive diagnostic aid to distinguish active IBD from IBS • Available by direct order for hospital and reference labs