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.
Study Type
OBSERVATIONAL
Enrollment
201
BÜHLMANN fPELA assays are immunoassays for the quantitative determination of fecal pancreatic elastase in human stool samples.
Universitätsklinikum Halle (Saale)
Halle, Germany
Clinical Performance of BÜHLMANN fPELA assays in the diagnosis of PEI
Diagnostic sensitivity and specificity of BÜHLMANN fPELA assays
Time frame: December 2021
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