Focus of the Report: This report focuses on fecal calprotectin (FC) testing for determining the prognosis of disease activity (i.e., predicting clinical relapse) in patients who are undergoing treatment for ulcerative colitis (UC).
Technology Description: Calprotectin is a calcium-binding protein that is abundant in neutrophils. During active intestinal inflammation, neutrophils are recruited to the inflamed intestinal mucosa and these cells release calprotectin into the stool. Levels of FC correlate with the number of neutrophils present in the gut mucosa, making it a specific marker for intestinal inflammation. Testing is conducted on outpatients and the results are interpreted by a gastroenterologist. Test results are used in conjunction with clinical evaluation and other diagnostic tests for predicting relapse.
Controversy: Although FC testing enables noninvasive assessment of UC disease activity, it is not as accurate as colonoscopy. Furthermore, FC levels can be elevated by gastrointestinal infections, colorectal cancer, and use of non-steroidal anti-inflammatory drugs, potentially leading to false-positive FC results.
What is the clinical validity of FC for prediction of treatment response in patients with active UC or clinical relapse of UC in patients in remission?
What is the clinical utility of FC in prediction of treatment response or clinical relapse after successful treatment in patients with UC?
How does FC compare with other interventions for prediction of treatment response or clinical relapse in patients with UC?
Are any safety issues associated with the FC test?
Have definitive patient selection criteria been established for use of the FC test for prediction of treatment response or clinical relapse in patients with UC?
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