Exocrine Pancreatic Insufficiency
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTBÜHLMANN fPELA assay
BÜHLMANN fPELA assays are immunoassays for the quantitative determination of fecal pancreatic elastase in human stool samples.
Sponsors
Bühlmann Laboratories AG
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* suspected exocrine pancreatic insufficiency * at least 18 years of age.
Exclusion criteria
* diarrhea (stool water content ≥ 75%) at the time of sample collection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Performance of BÜHLMANN fPELA assays in the diagnosis of PEI | December 2021 | Diagnostic sensitivity and specificity of BÜHLMANN fPELA assays |
Countries
Germany
Outcome results
None listed