Test ID: 199PC
Carbohydrate Antigen 19-9 (CA 19-9), Pancreatic Cyst Fluid
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Useful For Suggests clinical disorders or settings where the test may be helpful
As an adjunct in the assessment of pancreatic cysts, when used in conjunction with carcinoembryonic antigen (CEA), amylase, imaging studies and cytology.
Method Name A short description of the method used to perform the test
Immunoenzymatic Assay
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
Cancer Antigen 19-9 (CA 19-9)
Specimen Type Describes the specimen type needed for testing
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.
Collection Container/Tube: Body fluid container
Submission Container/Tube: Plastic vial
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.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | NA |
| Lipemia | NA |
| Icterus | NA |
| 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 Type | Temperature | Time |
|---|---|---|
| Pancreatic Cyst Fluid | Frozen (preferred) | 30 days |
| Refrigerated | 7 days |
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Carbohydrate antigen 19-9 (CA 19-9) is a modified Lewis(a) blood group antigen, and has been used as a tumor marker. Serum CA 19-9 concentrations may be elevated in patients with gastrointestinal malignancies such as cholangiocarcinoma, colon cancer, or pancreatic cancer. While serum CA 19-9 is neither sensitive nor specific for pancreatic cancer, concentrations of CA 19-9 in pancreatic cyst fluid may help determine whether a pancreatic cyst is benign.
Cystic lesions of the pancreas are of various types:
-Benign cysts:
- Inflammatory cysts (pseudocysts)
- Serous cysts (serous cystadenoma)
-Mucinous cysts:
- Premalignant (mucinous cystadenoma)
- Malignant (cystadenocarcinoma, intrapapillary mucinous neoplasia)
Pancreatic cyst fluid CA 19-9 results should be used in conjunction with imaging studies, cytology, and other cyst-fluid tumor markers, such as carcinoembryonic antigen (CEA) and amylase.
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
Cyst fluid carbohydrate antigen 19-9 (CA19-9) concentrations < or =37 U/mL indicate a low risk for a mucinous cyst, and are more consistent with serous cystadenoma or pseudocyst. The sensitivity and specificity are approximately 19% and 98%, respectively, at this concentration.
Correlation of these test results with cytology and imaging is recommended.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Carbohydrate antigen 19-9 (CA 19-9) and other tumor markers are not specific for malignancy and CA 19-9 testing has limited utility when used as the sole tumor marker test. Other tests (eg, CEA, amylase, cytology) should be performed in conjunction with CA 19-9 for assessing pancreatic cyst aspirates.
A low or negative result (<5 U/mL) may be uninformative or misleading since some individuals (Lewis nonsecretors) do not produce the CA 19-9 antigen. In such cases, a serum CA 19-9 measurement is necessary to verify that the patient is (or is not) a CA 19-9 secretor.
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. Snozek CL, Jenkins SM, Bryant SC, et al: Analysis of CEA, CA19-9 and amylase in pancreatic cyst fluid for diagnosis of pancreatic lesions. Clin Chem 2008;54(6 Suppl S):A126-127
2. van der Waaij LA, van Dullemen HM, Porte RJ: Cyst fluid analysis in the differential diagnosis of pancreatic cystic lesions: a polled analysis. Gastrointest Endosc 2005;62:383-389
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 a Beckman Coulter DXI 800. The Access GI Monitor assay is a 2-site immunoenzymatic sandwich assay. A sample is added to a reaction vessel along with paramagnetic particles coated with polyclonal goat antibiotin antibody, mouse monoclonal biotin conjugate, and buffered protein solution. After incubation in a reaction vessel, separation in a magnetic field, and washing to remove materials not bound to the solid phase, a monoclonal-alkaline phosphatase conjugate is added. After incubation in a reaction vessel, materials bound to the solid phase are held in a magnetic field, while unbound materials are washed away. 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 directly proportional to the concentration of CA 19-9 antigen in the sample. The amount of analyte in the sample is determined from a stored, multipoint calibration curve.(Package insert: Beckman Coulter, Inc., Fullerton, CA, 2010)
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.
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.
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.
86301
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 |
|---|---|---|
| 199P | CA19-9, Pancreatic Cyst | 26924-1 |
| SITE6 | Site | N/A |
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