Test Id : ELASF
Pancreatic Elastase, Feces
Useful For
Suggests clinical disorders or settings where the test may be helpful
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
A short description of the method used to perform the test
Enzyme-Linked Immunosorbent Assay (ELISA)
NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Aliases
Lists additional common names for a test, as an aid in searching
Pancreatic Elastase-1
Elastase-1
EL-1
FE-1
PE-1
Fecal Elastase
Elastase
PE stool
Specimen Type
Describes the specimen type validated for testing
Fecal
Shipping Instructions
Preferred shipping temperature is frozen. Refrigerated or ambient specimens received more than 72 hours post collection will be rejected.
Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
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 specimen and send frozen.
Additional Information:
1. Separate specimens must be submitted when multiple tests are ordered, with the exception of CALPR / Calprotectin, Feces. 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.
Forms
If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:
-General Request (T239)
Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.
1 g
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
| Specimens collected from diapers | Reject |
Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Fecal | Frozen (preferred) | 28 days | |
| Ambient | 72 hours | ||
| Refrigerated | 72 hours |
Useful For
Suggests clinical disorders or settings where the test may be helpful
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
Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Pancreatic elastase (PE) is a proteolytic enzyme produced in the pancreatic acinar cells. It is released as a zymogen, which is then converted to an active enzyme in the duodenum by trypsin. PE has an important role in digestion and proteolytically degrades proteins preferentially at alanine residues.
Exocrine pancreatic insufficiency (EPI) is a condition in which the pancreas does not produce sufficient digestive enzymes required to breakdown ingested food, leading to maldigestion and malabsorption.(1) Clinical symptoms of EPI include steatorrhea, bloating, abdominal discomfort, and weight loss.(2) EPI is most commonly caused by chronic pancreatitis but can also be associated with pancreatic cancer, pancreatic surgery, necrotizing acute pancreatitis, cystic fibrosis, inflammatory bowel disease (both Crohn disease and ulcerative colitis), diabetes (types I and II), gastric surgery, short bowel syndrome, and Zollinger-Ellison syndrome.(2,3) If left untreated, patients with EPI can experience weight loss and significant nutrient deficiencies. Treatment for EPI centers on administration of pancreatic enzyme replacement therapy.
Stool testing is a critical component for the diagnosis of EPI. The 72-hour fecal fat test is useful for evaluating for the presence of steatorrhea.(4) However, this testing is cumbersome for the patient and not easily tolerated due to the requirement of consuming 100 g fat/day. An alternate to the 72-hour fecal fat test is the measurement of PE in stool. The amount of PE in stool is representative of pancreatic enzyme production; patients with EPI may have reduced concentrations of PE in feces. Current guidelines from the American Gastroenterological Association identify PE in stool as the most appropriate initial test for evaluation of patients with a high probability of pancreatic disease and clinical signs consistent with malabsorption (5). However, the guidelines acknowledge that this testing can be prone to false-positive results, especially in patients with a low pre-test probability for EPI. In a meta-analysis, PE in stool demonstrated a pooled sensitivity of 77% and a specificity of 88%, when compared to secretin stimulation testing. In patients with a low-pretest probability for EPI, the false-positive rate was estimated to by 11%. In addition, the sensitivity of fecal PE is higher in patients with severe EPI compared to patients with moderate or mild disease.(6)
Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
<100 mcg/g (Severe Pancreatic Insufficiency)
100-200 mcg/g (Moderate Pancreatic Insufficiency)
>200 mcg/g (Normal)
Reference values apply to all ages.
Interpretation
Provides information to assist in interpretation of the test results
Pancreatic elastase concentrations above 200 mcg/g are normal and are not indicative of exocrine pancreatic insufficiency.
Pancreatic elastase concentrations from 100 to 200 mcg/g are suggestive for moderate exocrine pancreatic insufficiency.
Pancreatic elastase concentrations below 100 mcg/g are consistent with exocrine pancreatic insufficiency.
Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Normal concentrations of fecal pancreatic elastase (PE) do not exclude the possibility of exocrine pancreatic insufficiency (EPI), especially in cases of mild or moderate disease.
Decreased concentrations of fecal PE are not diagnostic for EPI, particularly in patients with low pre-test probability.
Consistency of raw fecal sample may affect analytical performance.
Clinical Reference
Recommendations for in-depth reading of a clinical nature
1. Phillips ME, Hopper AD, Leeds JS, et al. Consensus for the management of pancreatic exocrine insufficiency: UK practical guidelines. 2021;8(1):e000643
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. Leeds JS, Oppong K, Sanders DS. The role of fecal elastase-1 in detecting exocrine pancreatic disease. Nat Rev Gastroenterol Hepatol. 2011;8(7):405-415
4. 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(6):441-444
5. Whitcomb DC, Buchner AM, Forsmark CE. AGA clinical practice update o the epidemiology, evaluation, and management of exocrine pancreatic insufficiency: Expert review. Gastroenterology. 2023;165(5):1292-1301
6. Vanga RR, Tansil A, Sidiq S, et al. Diagnostic performance of measurement of fecal elastase-1 in detection of exocrine pancreatic insufficiency: Systemic review and meta-analysis. 2018;16(8):1220-1228
Method Description
Describes how the test is performed and provides a method-specific reference
The Immundiagnostik Pancreatic Elastase assay is an enzyme-linked immunosorbent assay. 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 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; 02/23/2023)
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.
Monday through Friday
Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.
Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
Fees :
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.
- Authorized users can sign in to Test Prices for detailed fee information.
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- Prospective clients should contact their account representative. For assistance, contact Customer Service.
Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.
This test has been cleared, approved, or is exempt by the US 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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
CPT codes are provided by the performing laboratory.
CPT codes are provided by the performing laboratory.
82653
LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.
| Test Id | Test Order Name | Order LOINC Value |
|---|---|---|
| ELASF | Pancreatic Elastase, F | 25907-7 |
| Result Id | Test Result Name |
Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
|
|---|---|---|
| ELASF | Pancreatic Elastase, F | 25907-7 |