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Test ID: PAMYB
Amylase, Pancreatic, Body Fluid

Secondary ID A test code used for billing and in test definitions created prior to November 2011

5079

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

Conditional

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

Pancreatic amylase will most frequently be ordered as a serum test to detect acute pancreatitis.

 

If a pleural effusion occurs as a complication of acute pancreatitis, excessive amounts of pancreatic amylase (p-amylase) in the effusion points to pancreatitis as the cause.

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

Monoclonal Antibody Technique

Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name

Amylase, Pancreatic, BF

Aliases Lists additional common names for a test, as an aid in searching

P-AMY (Pancreatic Amylase)
Pancreatic, Amylase, Body Fluids

Specimen Type Describes the specimen type needed for testing

Body Fluid

Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.

Container/Tube: Body fluid container

Specimen Volume: 0.5 mL

Additional Information: Indicate specimen source.

Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.

0.5 mL

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

Hemolysis

Mild OK; Gross OK

Lipemia

Mild OK; Gross OK

Icterus

Mild OK; Gross OK

Other

NA

 

Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.

Specimen TypeTemperatureTime
Body FluidRefrigerated (preferred)30 days
 Frozen 30 days

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.

 

Since the clinical use of amylase activity is usually to detect pancreatitis, the p-amylase form provides a useful test in the laboratory diagnosis of acute pancreatitis.

 

Pleural effusion may occur secondary to inflammatory pancreatic disease. Exocrine products of the pancreas will occur in such body fluids.

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.

Not applicable

Interpretation Provides information to assist in interpretation of the test results

Elevated pleural effusion alpha-amylase suggests acute pancreatitis as the cause of the effusion.

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

Serum reference values are not applicable to body fluid specimens. There are no established reference values for body fluid specimens.

Clinical Reference Provides recommendations for further in-depth reading of a clinical nature

Burtis CA, Ashwood ER: Clinical enzymology. In Tietz Textbook of Clinical Chemistry. Third edition. Philadelphia, WB Saunders, 1999, pp 617-721

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

After the inhibition of salivary amylase with a combination of 2 monoclonal antibodies, pancreatic alpha-amylase activity is assayed by a coupled kinetic colorimetric procedure which gives rise to 415 nm absorption proportional to the paranitrophenol released by the action of alpha-amylase and alpha-glucosidase.

 

In this procedure, the first incubation step results in the inhibition of human salivary alpha-amylase by 2 monoclonal antibodies which do not affect pancreatic alpha-amylase. After a second incubation with the substrate (G7)-p-nitrophenyl (G1)-alpha-D-maltoheptaoside, the activity of pancreatic alpha-amylase is measured. The alpha-amylase cleaves the substrate into fragments G2, G3, and G4. Further fragment hydrolysis by alpha-glucosidase yields p-nitrophenol and glucose. Enzyme activity is determined by the rate of increase of absorbance at 415 nm. Chromophore production is equimolar.

 

The simplified reaction is as follows:

 

 

P-amy

 

5 ET-G7PNP + 5 H20

--------->

2 ET-G5 + 2 G2PNP + 2 ET-G4
+2 G3PNP + ET-G3 + G4-PNP

 

alpha-glucosidase

 

2 G2PNP + 2 G3PNP + 14 H20

---------->

5 PNP + 14G

Abbreviations:

ET=ethylidene

G=glucose

PNP=p-nitrophenol

 

 

 

(Tietz NW, Burlina A, Gerhardt W, et al: Multicenter evaluation of a specific pancreatic isoamylase assay based on a double monoclonal - antibody technique, Clin Chem 1988;34:2096-2102; package insert: p-Amy EPS. Boehringer Mannheim Corporation, Indianapolis, IN)

Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.

Monday through Friday

Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.

1 day (not reported on Saturday or Sunday)

Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result

5 days

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

7 days

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

Rochester

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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) 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.

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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

82150

LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.

Result IDReporting NameLOINC Code
PAMBFAmylase, Pancreatic, BF48996-3
FLDFluid Type14725-6