ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool

Prior treatment

• Subjects receiving chemotherapy or systemic immunosuppressive drugs without completing an 8-week washout period IBD patients who have previously diagnosed with IBD managed with immunomodulators, 5-ASA or biologic therapies without completing an 8-week washout period for biologics and immunomodulators or 4 weeks for 5-ASA
• IBD patients who have previously been diagnosed with IBD and have undergone surgical resection or diversion procedure.
• Use of proton pump inhibitors (PPIs) or H2-receptor antagonists within the 2 weeks prior to providing the stool sample.
• Use of NSAIDs, including aspirin, on seven or more days within the 14 days prior to sample collection.

Other illness

• Known active intestinal cancer or in remission with abnormal levels (per physician assessment)
• Known active intestinal infection or history of treated intestinal infection with persistent abnormal levels (per physician assessment)
• Current or active upper gastrointestinal disease (e.g., esophagitis, gastritis, GERD, or acid reflux) with ongoing symptoms or requiring active treatment.
• Any condition that in the opinion of the investigator should preclude participation in the study.

Other

• Unable or unwilling to provide a stool specimen
• Samples are not collected according to sampling protocol.

• Male or female, ≥22 years of age (adults)
• Subjects with suspected inflammatory bowel disease or irritable bowel syndrome presenting one or more of the following symptoms: abdominal pain, diarrhea, altered appetite, anemia, or unexpected weight loss. Not all symptoms are required; clinical presentation must support suspicion of inflammatory bowel disease or irritable bowel syndrome in the investigator's opinion.
• Able to provide a sample either within 14 days before beginning bowel preparation for the scheduled colonoscopy, or between 3 and 14 days after the colonoscopy.
• Able to understand the study and the tasks required and sign the ICF