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

Inclusion criteria

• Male or female, ≥22 years of age (adults)
• Suspected inflammatory bowel disease or irritable bowel syndrome with symptoms such as abdominal pain, diarrhea, altered appetite, weight loss, or anemia
• Able to provide a sample according to the sampling protocol within 72-24 hours prior to the scheduled diagnostic endoscopy or 3-30 days after the colonoscopy.
• Able to understand the study and the tasks required and sign the ICF

Exclusion criteria

• Unable or unwilling to provide a stool specimen
• 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)
• IBD patients receiving chemotherapy or systemic immunosuppressive drugs without completing an 8-week washout period
• IBD patients who have previously diagnosed 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 a surgical resection or diversion procedure.
• Known upper Gl disease such as esophagitis or gastritis that might influence the study test's ability to detect intestinal inflammatory disease
• Have taken NSAIDS (including aspirin) on 7 or more days during the 2 weeks before providing the sample
• Samples are not collected according to sampling protocol.
• Any condition that in the opinion of the investigator should preclude participation in the study.
• Using an IRB approved consent form, all study participants will be advised of study requirements and potential risks associated with study participation.