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Test Code ELAST Pancreatic Elastase, Stool

Important Note

Effective 7/22/25, this test replaces 

Pancreatic Elastase, Feces

Additional Codes

Software Test Code
Label Text                                                     ELAST
EPIC LAB9404                                                     

Performing Laboratory

NorDx Laboratories - Scarborough Campus

Useful For

Evaluating patients with suspected exocrine pancreatic insufficiency, with symptoms of unexplained diarrhea, constipation, steatorrhea, flatulence, weight loss, upper abdominal pain, and food intolerances

 

Monitoring of exocrine pancreatic function in cystic fibrosis, diabetes mellitus, or chronic pancreatitis

Method Name

Chemiluminescent Immunoassay (CLIA)

Reference Values

< 100 µg/g - Severe Exocrine Pancreatic Insufficiency

100-200 µg/g - Mild to Moderate Exocrine Pancreatic Insufficiency

≥ 200 µg/g - Normal

Days and Times Test Performed

Monday through Friday, exclusive of select holidays

Report Available

Up to 4 days

Specimen Type

Stool

Preferred Container

Sterile Container

Preferred Volume

Stool: 5 g (Sterile Container)

Minimum Volume

Collecting minimum volumes can result in a need for sample recollection, and/or a delay in results. Minimum volumes are subjective and cannot account for all aspects of specimen and testing needs. Refer to the Preferred Volume section for optimal volumes for laboratory specimens.

 

Stool: 1 g (Sterile Container)

Specimen Collection and Handling

1. Collect a fresh random stool specimen, no preservatives, and store at 2-8° C during transport.

2. Separate specimens may be required when multiple tests are ordered. This test can share containers with a test for Calprotectin.

3. Specimen can not be collected from a diaper.

Specimen Stability Information

Specimen Type Temperature Time
Stool Refrigerated 7 days
  Ambient 8 hours
  Frozen (less than -20o C) 12 months

Add On Capable

Yes

Advance Beneficiary Notice Requirements

No ABN required

CPT Code Information

CPT Code CPT Description CPT Disclaimer
82653 Elastase, pancreatic (EL-1), fecal  

 

Rejection Information

Specimens with preservative are not acceptable.

Clinical Significance

Chronic pancreatitis is a chronic inflammatory disease of the pancreas, typically causing pain and/or permanent loss of function of the pancreas. A major complication in chronic pancreatitis is a condition called exocrine pancreatic insufficiency which causes maldigestion [1]. Exocrine pancreatic insufficiency occurs when the amount of enzymes released and transported to the small intestine is inadequate for proper food digestion and absorption of nutrients [2]. Clinical symptoms of pancreatic insufficiency include: steatorrhea, weight loss, abdominal discomfort due to maldigestion, and malnutrition [2]. Any condition that blocks the pancreatic ducts or damages or destroy the cells that produce elastase can cause pancreatic insufficiency [2]. Pancreatic insufficiency can often be found in patients with chronic pancreatitis, some cases of pancreatic cancer, cystic fibrosis, Shwachman-Diamond syndrome, and celiac disease as well as others diseases that affect the pancreas [4].
Pancreatic elastase 1 or fecal elastase 1 (FE-1) is a human pancreas specific enzyme. It has a molecular weight of 28 kDa with high affinity to the carboxyl group of alanine, valine, and leucine, and is highly stable during passage through the gastrointestinal tract [5]. FE-1 is enriched 5-6 fold in the feces compared with pancreatic juices and can be used as an indicator of pancreatic exocrine function [5]. FE-1 levels are decreased in patients with pancreatic insufficiency, with concentrations less than 100 μg/g in stool considered severe pancreatic insufficiency and greater than 200 μg/g considered a normal level [2]. FE-1 levels have been shown to correlate with other pancreatic function tests, such as the secretin-cholecystokinin or secretin-caerulein test. These tests are considered the “gold standard” test, however, they are invasive, time-consuming, and expensive [5]. An additional stool assay to diagnosis pancreatic insufficiency is Chymotrypsin, however, this assay requires three different stool samples from the patient, rather than the single stool sample required for detecting FE-1 [2]. The benefits of testing patients’ FE-1 levels to diagnosis pancreatic insufficiency include better sensitivity and specificity than chymotrypsin testing, and unlike other tests it is non-invasive and does not require patients to consume a special diet or discontinue pancreatic enzyme replacement therapy [1,2,4].

 

1. Lindvist, Bjorn. “Diagnosis and treatment of pancreatic exocrine insufficiency”. World Journal of Gastroenterology 2013 Nov 14;19(42):7258-7266.
2. Kellerund, Jutta. Layer, Peter. (2015). “Diagnosis of pancreatic exocrine insufficiency in chronic pancreatitis”. Pancreapedia: Exocrine Pancreas Knowledge Base, DOI: 10.3998/panc.2015.37
3. Dominguez-Munoz, J. Enrique. “Pancreatic exocrine insufficiency: Diagnosis and treatment”. Journal of Gastroenterology and Hepatology. 26 (2011) Suppl. 2; 12-16.
4. Duggan, Sinead N, Chonchubhair, Hazel M Ni, Lawal, Oladapo. O’Connor, Donal, and Conlon Kevin C. “Chronic Pancreatitis: A diagnostic dilemma”. World Journal of Gastroenterology 2016 Feb 21; 22(7):2304-2313.

5. Löser C, Möllgaard A, Fölsch UR (October 1996). "Faecal elastase 1: a novel, highly sensitive, and specific tubeless pancreatic function test". Gut. 39 (4): 580–6.

Performing Location

NorDx Laboratories