Can be used for the diagnosis or the exclusion of exocrine pancreatic insufficiency, which may be associated with chronic pancreatitis, cystic fibrosis, carcinoma of the pancreas, diabetes mellitus type 1 (insulin-dependent diabetes mellitus), Shwachman-Diamond syndrome, and other etiologies of pancreatic insufficiency.
This assay does not measure the substituted enzyme (Pancreatin) and, therefore, is not necessary to stop medication before taking a sample.
Screw cap plastic container (sterile)
Ambient – 14 days
Refrigerated – 14 days
Frozen – 14 days
Freeze/thawcycles: stable x3
Enzyme-linked immunosorbent assay (ELISA) based upon a monoclonal antibody-based detection system specific for pancreatic elastase-1 (PEL-1)
Normal: >200 μg elastase/g fecal material
Moderate insufficiency: 100−200 μg elastase/g fecal material
Severe insufficiency: <100 μg elastase/g fecal material