ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool
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.
Description
The clinical study serves to confirm the sensitivity and specificity of the ALPCO Calprotectin CLIA as compared to gastroenterologist diagnosis (including colonoscopy results and other clinical information) in patients with signs and symptoms of IBS or IBD, using the proposed cut-off values (50 and 100 µg/g) as both an aid in the diagnosis of Inflammatory Bowel Disease and as an aid to differentiate IBD from Irritable Bowel Syndrome. The clinical study will be conducted in compliance with applicable requirements in the protection of human subjects regulations in 21 CFR part 50, the institution…
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- Yes
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…
Interventions
- DeviceALPCO Calprotectin CLIA
Measurement of calprotectin in feces
Locations (3)
- Med-Care Research CorpMiami, Florida
- ALPCOSalem, New Hampshire
- Gastro Intestinal Research Institute of Northern Ohio,Westlake, Ohio