Test Details
Methodology
Chemiluminescent immunoassay (CLIA)
Result Turnaround Time
4 - 6 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Use
This test 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.
Custom Additional Information
The polyclonal antibodies used in this assay are specifically directed against defined sequences of the human pancreatic elastase molecule. The enzyme stability is remarkably high despite its proteolytic activity, as elastase is found in feces in about a sixfold concentration as in pancreatic fluid. The determination of enzyme concentration in feces reflects the exocrine secretory capacity of the pancreas.
Specimen Requirements
Specimen
Stool (unpreserved, random)
Volume
3 g
Minimum Volume
1 g (Note: This volume does not allow for repeat testing.)
Container
Screw-capped plastic vial
Collection Instructions
Do not contaminate outside of container. Do not overfill container. Do not use a preservative.
Stability Requirements
Temperature | Period |
|---|---|
Room temperature | 8 hours (stability provided by manufacturer or literature reference) |
Refrigerated | 7 days (stability provided by manufacturer or literature reference) |
Frozen | 12 months (stability provided by manufacturer or literature reference) |
Freeze/thaw cycles | Stable x2 (stability provided by manufacturer or literature reference) |
Reference Range
• Normal: >200 μg elastase/g fecal material
• Moderate pancreatic insufficiency: 100−200 μg elastase/g fecal material
• Severe pancreatic insufficiency: <100 μg elastase/g fecal material
Storage Instructions
Transport specimen frozen.
Patient Preparation
This assay does not measure the substituted enzyme (Pancreatin) and, therefore, it is not necessary to stop medication before taking a sample.
Causes for Rejection
Serum or plasma received; stool contaminated with urine; preserved stool received
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 123234 | Pancreatic Elastase, Fecal | 25907-7 | 123236 | Pancreatic Elastase, Fecal | ug Elast./g | 25907-7 |
| Order Code | 123234 | |||||
| Order Code Name | Pancreatic Elastase, Fecal | |||||
| Order Loinc | 25907-7 | |||||
| Result Code | 123236 | |||||
| Result Code Name | Pancreatic Elastase, Fecal | |||||
| UofM | ug Elast./g | |||||
| Result LOINC | 25907-7 |