Carcinoembryonic Antigen (CEA), Pancreatic Cyst Fluid
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
When used in conjunction with imaging studies, cytology, and other pancreatic cyst fluid tumor markers:
-Distinguishing between mucinous and nonmucinous pancreatic cysts
-Determining the likely type of malignant pancreatic cyst
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
CEA, Pancreatic Cyst
CEA (Carcinoembryonic Antigen)
Specimen Type Describes the specimen type needed for testing
Pancreatic Cyst 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: Plain, plastic, screw-top tube
Specimen Volume: 1 mL
Forms: If not ordering electronically, submit a General Request Form (Supply T239) with the specimen.
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 (Samples <0.5 mL may be rejected)
Gross reject; Mild OK
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|Pancreatic Cyst Fluid||Frozen (preferred)||30 days|
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Cystic lesions of the pancreas are of various types including:
- Inflammatory cysts (pseudocysts)
- Serous cysts (serous cystadenoma)
- Premalignant (mucinous cystadenoma)
- Malignant (cystadenocarcinoma, intrapapillary mucinous neoplasia)
The diagnosis of pancreatic cyst type is often difficult and may require correlating imaging studies with results of cytologic examination and tumor marker testing performed on cyst aspirates. Various tumor markers have been evaluated to distinguish nonmucinous, nonmalignant pancreatic cysts from mucinous cysts, which have a high likelihood of malignancy. Carcinoembryonic antigen (CEA) has been found to be the most reliable tumor marker for identifying those pancreatic cysts that are likely mucinous. In cyst aspirates, CEA concentrations > or =200 ng/mL are highly suspicious for mucinous cysts. The greater the CEA concentration, the greater the likelihood that the mucinous cyst is malignant. However, CEA testing does not reliably distinguish between benign, premalignant, or malignant mucinous cysts. CEA test results should be correlated with the results of imaging studies, cytology, other cyst fluid tumor markers (ie, amylase and CA 19-9), and clinical findings for diagnosis.
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.
A pancreatic cyst fluid carcinoembryonic antigen (CEA) concentration of > or =200 ng/mL is very suggestive for a mucinous cyst but is not diagnostic. The sensitivity and specificity for mucinous lesions are approximately 62% and 93%, respectively, at this concentration. Cyst fluid CEA concentrations of < or =5 ng/mL indicate a low risk for a mucinous cyst, and are more consistent with serous cystadenoma, fluid collections complicating pancreatitis, cystic neuroendocrine tumor, or metastatic lesions. CEA values between these extremes have limited diagnostic value.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
These test results should not be the sole basis for diagnosis. Test results should be always correlated with imaging and cytology.
This test does not distinguish between malignant and nonmalignant mucinous cysts.
This test should not be ordered for pancreatic fluid of noncyst origin (eg, pancreatic duct fluid; peripancreatic fluid) since reference values have not been established for this specimen type. Contact Mayo Medical Laboratories for ordering assistance.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Brugge WR, Lewandrowski K, Lee-Lewandrowski E, et al: Diagnosis of pancreatic cystic neoplasms: a report of cooperative pancreatic cyst study. Gastroenterology 2004 May;126:1330-1336
2. Snozek CL, Jenkins SM, Bryant SC, et al: Analysis of CEA, CA 19-9, and amylase in pancreatic cyst fluid for diagnosis of pancreatic lesions. Clin Chem 2008;54(Suppl S):A126-127
3. Khalid A, Brugge W: ACG practice guidelines for the diagnosis and management of neoplastic pancreatic cysts. Am J Gastroenterol 2007 Oct;102(10):2339-2349
Method Description Describes how the test is performed and provides a method-specific reference
The instrument used is Beckman Coulter UniCel DXI 800. The Access carcinoembryonic antigen (CEA) assay is a 2-site immunoenzymatic sandwich assay using 2 mouse monoclonal anti-CEA antibodies (Mab) that react with different epitopes of CEA. A sample is added to a reaction vessel, along with the first anti-CEA Mab-alkaline phosphatase conjugate and the second anti-CEA Mab bound to paramagnetic particles. The incubation is followed by a magnetic separation and washing. The chemiluminescent substrate Lumi-Phos 530 is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is proportional to the concentration of CEA in the sample. The amount of analyte in the sample is determined by means of a stored, multipoint calibrator curve.(Package insert: Beckman Coulter, Inc., Fullerton, CA, 2007)
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; Varies
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.
Same day/1 day
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
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 The location of the laboratory that performs the test
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.
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 ID||Reporting Name||LOINC Code|
|CEAP||CEA, Pancreatic Cyst||12515-3|