Fecal pancreatic elastase testing measures the concentration of pancreatic elastase in stool to help assess exocrine pancreatic function. Pancreatic elastase is an enzyme produced by the pancreas and released into the duodenum. It remains stable during intestinal transit, making stool measurement useful as an indirect indicator of pancreatic enzyme secretion.1
Exocrine pancreatic insufficiency (EPI) occurs when insufficient pancreatic digestive enzymes reach the small intestine to support normal digestion. It can impair nutrient absorption and contribute to weight loss, malnutrition, and deficiencies in fat-soluble vitamins A, D, E, and K.2
Conditions associated with EPI include chronic pancreatitis, cystic fibrosis, and previous pancreatic surgery. Longstanding diabetes is also associated with increased risk. Symptoms can include fatty stools (steatorrhea), weight loss, bloating, and excessive gas.2
It’s important to note that symptoms alone do not establish EPI. Laboratory findings should also be considered alongside symptoms, nutritional status, and relevant medical history.
Fecal pancreatic elastase concentrations help assess exocrine pancreatic function. The following thresholds provide general interpretive guidance.
> 200 µg/g1
Generally considered within normal range
100-200 µg/g2
Indeterminate for EPI; further evaluation needed
<100 µg/g2
Suggestive of EPI
Results should be interpreted according to the applicable assay instructions and the laboratory’s established reporting criteria.
Fecal pancreatic elastase testing is widely used as an initial, non-invasive assessment when EPI is suspected.2 Practical benefits include:
However, there are some important limitations to consider, such as:
Immundiagnostik, Inc. offers the IDK® Pancreatic Elastase ELISA, an enzyme-linked immunosorbent assay for the quantitative determination of human pancreatic elastase in stool samples. The U.S. version is FDA Class 1 exempt and intended for in vitro diagnostic use by laboratory professionals. A Health Canada licensed version is also available.
View assay specifications and request the kit manual:
Additionally, the IDK® Pancreatic Elastase ELISA is compatible with the IDK Extract® Stool Sample Collection Tubes for simplified sample collection, preparation, and storage.
The IDK® Pancreatic Elastase ELISA is FDA Class 1 Exempt. For In Vitro Diagnostic Use. Health Canada Licensed. For Laboratory Professional Use Only.
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