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BÜHLMANN FPELA in the Diagnosis of Exocrine Pancreatic Insufficiency
The study shall determine the clinical performance of the BÜHLMANN fecal pancreatic elastase (fPELA) assays in the diagnosis of exocrine pancreatic insufficiency (PEI). This is a observational and cross-sectional performance study. Specimens and clinical data are collected by a single study site. Included are subjects for which pancreatic elastase testing was indicated due to a suspected exocrine pancreatic insufficiency and which were at least 18 years of age. Subjects which suffered from diarrhea (stool water content ≥ 75%) at the time of sample collection are excluded from the study.
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