DIAGNOSTIC TEST AND KIT FOR DISEASE OR DISORDERS IN THE DIGESTIVE SYSTEM

A new diagnostic test and kit for diseases or disorders in the digestive system. This study describes method for extraction and quantification of calprotectin (L1 protein) in feces by enzyme immunoassay. This protein is a prominent antimicrobial component of neutrophils, monocytes, macrophages and squamous epithelia. Calprotectin was stable in feces during storage for seven days at room temperature. Fecal calprotectin quantitated in a five gram sample taken from a 24 hours feces collection gave a reliable estimate of calprotectin found in the pooled collection. The assay had a within assay precision (=CV) of 1,9 % and a between assay precision of 14,8 %. The following mean fecal calprotectin levels were found: Healthy subjects (n=33) 3095 .mu.g/l, hospital controls (n=40): 14637 .mu.g/l, patients with inflammatory bowel disease (Crohn's disease and ulcerative colitis), (n=28) 40850 .mu.g/l. The differences between the means are highly significant. All patients with IBD and ten out of eleven patients with gastrointestinal carcinomas had calprotectin level above the suggested reference limit of 9000 .mu.g/l. Determination of fecal calprotectin is an important routine parameter for monitoring IBD and gastrointestinal cancer.