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ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool
Sponsor: American Laboratory Products Company
Summary
The ALPCO Calprotectin CLIA is an in vitro diagnostic test intended to quantitatively measure concentrations of fecal calprotectin in human stool samples. Calprotectin is a protein biomarker of mucosal inflammation. Measurement of calprotectin can aid in the diagnosis of Inflammatory Bowel Diseases (IBD), specifically Crohn's Disease (CD) and Ulcerative Colitis (UC), as well as aid in the differentiation of IBD from Irritable Bowel Syndrome (IBS) when used in conjunction with other diagnostic testing and the total clinical picture. The goal of the study is to generate data to support positive and negative predictive value of the ALPCO Calprotectin assay in patients with signs and symptoms of IBS or IBD.
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
OBSERVATIONAL
Enrollment
220
Start Date
2025-03-25
Completion Date
2026-12-31
Last Updated
2026-02-11
Healthy Volunteers
Yes
Conditions
Interventions
ALPCO Calprotectin CLIA
Measurement of calprotectin in feces
Locations (3)
Med-Care Research Corp
Miami, Florida, United States
ALPCO
Salem, New Hampshire, United States
Gastro Intestinal Research Institute of Northern Ohio,
Westlake, Ohio, United States