Test Catalog

Test Id : AMLPC

Amylase, Pancreatic Cyst Fluid

Useful For
Suggests clinical disorders or settings where the test may be helpful

Aiding in distinguishing between pseudocysts and other types of pancreatic cysts, when used in conjunction with imaging studies, cytology, and other pancreatic cyst fluid tumor markers

Method Name
A short description of the method used to perform the test

Substrate Kinetic

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Amylase, Pancreatic Cyst

Specimen Type
Describes the specimen type validated for testing

Pancreatic Cyst Fluid

Ordering Guidance

For other body fluid specimens (eg, peritoneal, pleural), order AMBF / Amylase, Body Fluid. Testing will be changed to AMBF if this test is ordered on any fluid other than pancreatic fluid.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Supplies: Aliquot Tube, 5 mL (T465)

Container/Tube: Plain, plastic, screw top tube

Specimen Volume: 1 mL

Additional Information: A minimum of 0.5 mL is required for testing; specimens <0.5 mL may be rejected.

Forms

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.5 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis 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
Pancreatic Cyst Fluid Frozen (preferred) 30 days
Ambient 7 days
Refrigerated 7 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

Aiding in distinguishing between pseudocysts and other types of pancreatic cysts, when used in conjunction with imaging studies, cytology, and other pancreatic cyst fluid tumor markers

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Amylases are a group of hydrolases that degrade complex carbohydrates into fragments. Amylase is produced by the exocrine pancreas and the salivary glands to aid in the digestion of starch. It is also produced by the small intestine mucosa, ovaries, placenta, liver, and fallopian tubes.

 

Measurement of amylase in pancreatic cyst fluid is often used in conjunction with tumor markers, carcinoembryonic antigen and CA19-9, as an aid in the differential diagnosis of pancreatic cysts lesions. Amylase seems to be particularly helpful in excluding pancreatic pseudocysts. A number of studies have demonstrated that amylase levels are typically very high, usually in the thousands in pseudocysts, therefore, low amylase values virtually excludes pseudocysts. Based on the evidence available, the American College of Gastroenterology (ACG) practice guidelines for the Diagnosis and Management of Neoplastic Pancreatic Cysts suggest that an amylase cutoff value of 250 U/L is useful to exclude pseudocysts.

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.

An interpretive report will be provided.

Interpretation
Provides information to assist in interpretation of the test results

A pancreatic cyst fluid amylase concentration of less than 250 U/L indicates a low risk of a pseudocyst and is more consistent with cystic neoplasms such as mucinous cystic neoplasms (MCN), intraductal papillary mucinous neoplasm (IPMN), serous cystadenomas, cystic neuroendocrine tumor, and mucinous cystadenocarcinoma. High pancreatic cyst fluid amylase values are nonspecific and occur both in pseudocysts and some mucin-producing cystic neoplasms including MCN, IPMN, and mucinous cystadenocarcinoma.

 

In-house studies to verify this cutoff value showed that 94% (66/70) of pseudocysts had a value of greater or equal to 250 U/L. Cysts with amylase levels of less than 250 U/L included 69% of adenocarcinomas, 31% of intraductal papillary mucinous neoplasia, 55% of mucinous cystadenomas, 64% serous cystadenomas, and 6% of pseudocysts. Therefore, using a cutoff of less than 250 U/L to exclude a pseudocyst has 94% sensitivity and 42% specificity.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

This test result should not be the sole basis for diagnosis. Test results should always be correlated with imaging and cytology.

Supportive Data

In-house studies to verify the cutoff value of 250 U/L showed that 94% (66/70) of pseudocysts had a value of greater or equal to 250 U/L. Cysts with amylase levels of less than 250 U/L included 69% of adenocarcinomas, 31% of intraductal papillary mucinous neoplasia, 55% of mucinous cystadenomas, 64% serous cystadenomas, and 6% of pseudocysts. Therefore, using a cutoff of less than 250 U/L to exclude a pseudocyst has 94% sensitivity and 42% specificity.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Snozek CL, Mascarenhas RC, O'Kane DJ: Use of cyst fluid CEA, CA19-9, and amylase for evaluation of pancreatic lesions. Clin Biochem. 2009;42:1585-1588

2. van der Waaij LA, van Dullemen HM, Porte RJ: Cyst fluid analysis in the differential diagnosis of pancreatic cystic lesions: a pooled analysis. Gastrointest Endosc. 2005;62:383-389

3.  Elta GH, Enestvedt BK: ACG clinical guideline for the diagnosis and management of pancreatic cysts. Am J Gasroenterol. 2018;113:464-479

4. Brugge WR: Diagnosis and management of cystic lesions of the pancreas. J Gastrointest Oncol. 2015;6(4):375-388. doi:10.3978/j.issn.2078-6891.2015.057

Method Description
Describes how the test is performed and provides a method-specific reference

The Roche amylase method is an enzymatic colorimetric test using 4,6-ethyliden (G7)-p-nitrophenol (G1)-alpha, D-maltoheptaoside (ethylidene-G7PNP) as a substrate. Human salivary and pancreatic amylases (alpha-amylase) convert the substrate at approximately the same rate. The alpha-amylase cleaves the substrate into G2, G3, G4 p-nitrophenol (PNP) fragments. The G2, G3, and G4 PNP fragments are further hydrolyzed by an alpha-glucosidase to yield PNP and glucose. The rate of increase in absorbance at 415 nm (measuring the increase in PNP) is directly proportional to amylase activity.(Package insert: Roche AMYL2 reagent. Roche Diagnostic Corp; V10 12/2018)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

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 Saturday

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.

Same day/1 to 3 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

12 months

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

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.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. 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 modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

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.

82150

LOINC® Information

Test Id Test Order Name Order LOINC Value
AMLPC Amylase, Pancreatic Cyst 48996-3
Result Id Test Result Name Result LOINC Value
Result LOINC Value Tooltip
AMYPC Amylase, Pancreatic Cyst 48996-3
SITE6 Site 39111-0

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports