The purpose of this study is to confirm the sensitivity and specificity of the BÜHLMANN fCAL™ ELISA as an aid in diagnosis to differentiate between Inflammatory Bowel Disease (IBD; Crohn's Disease (CD), Ulcerative Colitis (UC), or indeterminate colitis) and Irritable Bowel Syndrome (IBS). To estimate the predictive value of a positive test (positive predictive value (PPV)) and the predictive value of a negative test (Negative Predictive Value (NPV)) using the proposed test outcomes for BÜHLMANN Calprotectin Test results when used in patients referred for diagnostic evaluation with signs and symptoms suggestive of either IBS or IBD. To confirm the inter-laboratory consistency of test results for the BÜHLMANN fCAL™ ELISA. To provide exploratory observations of test results in patients between the age of 2 and 21 years. To provide a sample set from normal subjects with no symptoms or signs of gastrointestinal disease for use in Expected Value Testing.
Study Type
OBSERVATIONAL
Enrollment
478
Stool sample collected by the subject, sent study laboratories where fecal calprotectin levels are quantified.
Stanford Center for Clinical & Translational Research & Education
Palo Alto, California, United States
Gastro Health
Miami, Florida, United States
Gastroenterology Assocaites of Central Georgia
Macon, Georgia, United States
Carle Foundation, Center for Digestive and Liver Disease
Urbana, Illinois, United States
Beth israel Deaconess Medical Center
Boston, Massachusetts, United States
Great Lakes Gastroenterology Research, LLC.
Mentor, Ohio, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States
Clinical value of in vitro diagnostic (IVD) device
Sensitivity, specificity; Positive predictive value (PPV), negative predictive value (NPV) and likelihood ratios (positive and negative)
Time frame: End of Study
normal Calprotectin values
Calprotectin values from normal healthy donors will be calculated
Time frame: End of Study
Clinical value of IVD device in pediatric population
Results of the pediatric population will be used as preliminary and exploratory evidence that calprotectin test can be used in this population
Time frame: End of Study
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