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Test Code ELAS Pancreatic Elastase, Feces

Reporting Name

Pancreatic Elastase, F

Useful For

Diagnosis of exocrine pancreatic insufficiency in case 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

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Fecal


Shipping Instructions


Preferred shipping temperature is frozen. Refrigerated or ambient specimens received more than 72 hours post collection will be rejected.



Specimen Required


Supplies: Stool container, Small (Random), 4 oz (T288)

Container/Tube: Stool container

Specimen Volume: 5 g

Collection Instructions:

1. Collect a fresh random fecal specimen, no preservatives.

2. If specimen is sent refrigerate, send immediately after collection.

3. If specimen cannot be sent immediately, freeze and send frozen (preferred).

Additional Information:  

1. Separate specimens must be submitted when multiple tests are ordered. If only a single specimen is collected, it must be split prior to transport.

2. Testing cannot be added on to a previously collected specimen.


Specimen Minimum Volume

1 g

Specimen Stability Information

Specimen Type Temperature Time Special Container
Fecal Frozen (preferred) 28 days
  Ambient  72 hours
  Refrigerated  72 hours

Reference Values

<100 mcg/g (Severe Pancreatic Insufficiency)

100-200 mcg/g (Moderate Pancreatic Insufficiency)

>200 mcg/g (Normal)

Reference values apply to all ages.

Day(s) and Time(s) Performed

Monday through Friday; 8 a.m.

Test Classification

This test has been cleared, approved or is exempt by the U.S. Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

83520

LOINC Code Information

Test ID Test Order Name Order LOINC Value
ELASF Pancreatic Elastase, F 25907-7

 

Result ID Test Result Name Result LOINC Value
ELASF Pancreatic Elastase, F 25907-7

Clinical Reference

1. Leeds JS, Oppong K, Sanders DS: The role of fecal elastase-1 in detecting exocrine pancreatic disease. Nat Rev Gastroenterol Hepatol. 2011;8:405-415

2. Capurso G, Traini M, Piciucchi M, Signoretti M, Arcidiacono PG: Exocrine pancreatic insufficiency: prevalence, diagnosis, and management. Clin Exp Gastroenterol. 2019;12:129-139

3. Chowdhury SD, Kurien RT, Ramachandran A, et al: Pancreatic exocrine insufficiency: Comparing fecal elastase 1 with 72-h stool for fecal fat estimation. Indian J Gastroenterol. 2016;35:441-444

Method Description

The Immundiagnostik Pancreatic Elastase assay is an enzyme-linked immunosorbent assay (ELISA). Calibrators, controls, and diluted patient samples are added to a 96-well plate pre-coated with monoclonal antibodies to pancreatic elastase. If present, pancreatic elastase will bind to the antibodies on the surface of the microtiter wells. After a wash step, a peroxidase-labeled conjugate (mouse anti-pancreatic elastase) is added. After another washing step, substrate tetramethylbenzidine (TMB) is added, which reacts with the peroxidase. An acidic stop solution is added causing the color to change from blue to yellow. The intensity of the yellow color is directly proportional to the concentration of pancreatic elastase. A dose response curve of absorbance unit (optical density at 450 nm) vs. concentration is generated using the values obtained from the standards. Pancreatic elastase present in the patient samples is determined directly from this curve.(Package insert: IDK Pancreatic Elastase ELISA kit. Immundiagnostik AG; 2019)

Analytic Time

3 days

Reject Due To

Specimens collected from diapers Reject

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)

Secondary ID

609492