Test Catalog

Test Id : 199PC

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Carbohydrate Antigen 19-9 (CA 19-9), Pancreatic Cyst Fluid

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Overview

Test Catalog

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, amylase, imaging studies and cytology

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

Immunoenzymatic Assay

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

CA19-9, Pancreatic Cyst

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

CA 19-9 (Carbohydrate Antigen 19-9)

Cancer Antigen 19-9 (CA 19-9)

Specimen Type
Describes the specimen type validated for testing

Pancreatic Cyst Fluid

Ordering Guidance

This test should not be ordered for pancreatic fluid of noncystic origin (eg, pancreatic duct fluid, peripancreatic fluid) since reference values have not been established for those specimen types. For ordering assistance call 800-533-1710.

ORDER QUESTIONS AND ANSWERS

Question ID Description Answers
SITE6 Site

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

Patient Preparation: For 12 hours before this procedure do not take multivitamins or dietary supplements containing biotin (vitamin B7), which is commonly found in hair, skin, and nail supplements and multivitamins.

Container/Tube: Plain, plastic, screw-top tube

Specimen Volume: 1 mL

Forms

If not ordering electronically, complete, print, and send an Oncology Test Request (T729) with the specimen.

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.

0.5 mL

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

Gross hemolysis Reject
Gross icterus OK

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) 90 days
Refrigerated 7 days
Ambient 72 hours

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, amylase, imaging studies and cytology

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 that 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 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 less than 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, carcinoembryonic antigen, 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.

 

In rare cases, some individuals can develop antibodies to mouse or other animal antibodies (often referred to as human anti-mouse antibodies [HAMA] or heterophile antibodies), which may cause interference in some immunoassays. Caution should be used in interpretation of results, and the laboratory should be alerted if the result does not correlate with the clinical presentation.

Clinical Reference
Recommendations for 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(3):383-389

3. Khalid A, Brugge W. ACG practice guidelines for the diagnosis and management of neoplastic pancreatic cysts. Am J Gastroenterol. 2007;102(10):2339-2349

4. Elta GH, Enestvedt BK, Sauer BG, Lennon AM. ACG clinical guideline: diagnosis and management of pancreatic cysts. Am J Gastroenterol. 2018;113(4):464-479. doi:10.1038/ajg.2018.14

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

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: Access GI Monitor. Beckman Coulter, Inc.; 04/2019)

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 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.

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 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 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.

86301

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
199PC CA19-9, Pancreatic Cyst 97750-4
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.
199P CA19-9, Pancreatic Cyst 97750-4
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