Irritable Bowel Syndrome Clinical Trial
Official title:
Clinical Study of the BÜHLMANN fCAL™ ELISA as an Aid in the Differentiation of Inflammatory Bowel Disease From Irritable Bowel Syndrome
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.
n/a
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