Test Catalog

Test Id : PF199

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Carbohydrate Antigen 19-9 (CA 19-9), Pleural Fluid

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Overview

Test Catalog

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

An adjuvant to cytology and imaging studies to differentiate between nonmalignant and malignant causes of pleural effusions

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

CA 19-9, Pleural Fluid

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

CA199

CA19-9

CA19.9

Carbohydrate Antigen 19-9

Specimen Type
Describes the specimen type validated for testing

Pleural Fluid

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

Patient Preparation: For 12 hours before specimen collection 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: 2 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 (Samples <0.5 mL may be rejected)

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
Pleural Fluid Frozen (preferred) 90 days
Refrigerated 14 days
Ambient 7 days

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

An adjuvant to cytology and imaging studies to differentiate between nonmalignant and malignant causes of pleural effusions

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

Pleural effusions occur as a consequence of either nonmalignant conditions (including congestive heart failure, pneumonia, pulmonary embolism, and liver cirrhosis) or malignant conditions (including lung, breast, and lymphoma cancers). Diagnosing the cause of an effusion can be difficult, requiring cytological examination of the fluid. Analysis of various tumor markers in pleural fluid has shown that these markers can differentiate between effusions caused by nonmalignant and malignant conditions and can enhance cytology findings.

 

Carbohydrate antigen 19-9 (CA 19-9) is a modified Lewis(a) blood group antigen. Healthy adults typically produce low to undetectable levels of CA 19-9. Serum concentrations of CA 19-9 may be elevated in patients with certain malignancies that secrete CA 19-9 into circulation, including cholangiocarcinoma, colorectal, stomach, bile duct, lung, ovarian, and pancreatic cancers.

 

Pleural fluid concentrations of CA 19-9 have been reported to be elevated in patients with certain malignancies. Malignancies that can secrete CA 19-9 and elevate serum CA 19-9 concentrations, including cholangiocarcinoma, colorectal, stomach, bile duct, lung, ovarian, and pancreatic cancers, typically also elevate CA 19-9 in pleural fluid. In contrast, malignancies that do not secrete CA 19-9, including mesothelioma, lymphoma, leukemia, and melanoma, have low concentrations of CA 19-9 in pleural fluid comparable to concentrations observed in nonmalignant effusions.

CA 19-9 results should be used in conjunction with cytological analysis of pleural fluid, imaging studies, and other clinical findings.

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 pleural fluid carbohydrate antigen 19-9 (CA 19-9) concentration of 20.0 U/mL or higher is suspicious, but not diagnostic, of a malignant source of the effusion. This cutoff yielded a sensitivity of 35%, specificity of 95%, and positive predictive value of 88% in a study of 200 patients presenting with effusion. CA 19-9 concentrations were significantly higher in effusions caused by CA 19-9-secreting malignancies, including cholangiocarcinoma, colorectal, stomach, bile duct, lung, ovarian, and pancreatic cancers. However, effusions caused by non-CA 19-9-secreting malignancies, including lymphoma, mesothelioma, leukemia, and melanoma, routinely had CA 19-9 concentrations below 20.0 U/mL. Therefore, negative results should be interpreted with caution, especially in patients who have or are suspected of having a non-CA 19-9-secreting malignancy.

 

Correlation of all tumor marker results with cytology and imaging is highly recommended.

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. Carbohydrate antigen 19-9 (CA 19-9) is not specific for malignancy and testing has limited utility when used as the sole diagnostic test. Test results should be always correlated with cytology, imaging, and other clinical findings.

 

A low or negative CA 19-9 result (<20.0 U/mL) may be uninformative or misleading, as certain malignancies do not secrete CA 19-9 and will not produce elevated CA 19-9 concentrations in pleural effusions. Negative results should be interpreted with caution in patients who have or are suspected of having a non-CA 19-9-secreting malignancy or who have a cancer of unknown primary origin. Alternative methodologies, including cytology, imaging, and other tumor markers, are recommended instead.

 

Certain individuals (Lewis nonsecretors) do not produce the CA 19-9 antigen. A low or negative CA 19-9 result may, therefore, be uninformative or misleading in these individuals. Measuring serum CA 19-9 concentrations may be helpful to determine if the patient is a Lewis nonsecretor.

 

Serum CA 19-9 concentrations have been reported to be elevated as a consequence of certain nonmalignant conditions, including liver cirrhosis, pancreatitis, gallstones, and cholecystitis. It is unknown whether these conditions also cause CA 19-9 elevations in pleural fluid. Results should therefore be interpreted with caution in patients with these conditions.

 

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. Shitrit D, Zingerman B, Shitrit ABG, Shlomi D, Kramer MR: Diagnostic value of CYFRA 21-1, CEA, CA 19-9, CA 15-3, and CA 125 assays in pleural effusions: analysis of 116 cases and review of the literature. Oncologist. 2005 Aug;10(7):501-507

2. Hackbarth JS, Murata K, Reilly WM, Algeciras-Schimnich A: Performance of CEA and CA19-9 in identifying pleural effusions caused by specific malignancies. Clin Biochem. 2010 Sep;43(13-14):1051-1055

3. Block DR, Algeciras-Schimnich A: Body fluid analysis: clinical utility and applicability of published studies to guide interpretation of today's laboratory testing in serous fluids. Crit Rev Clin Lab Sci. 2013 Jul-Oct;50(4-5):107-124. doi: 10.3109/10408363.2013.844679

4. Yang Y, Liu YL, Shi HZ: Diagnostic accuracy of combinations of tumor markers for malignant pleural effusion: An updated meta-analysis. Respiration. 2017;94(1):62-69. doi: 10.1159/000468545

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 carbohydrate antigen 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 assay. Beckman Coulter, Inc.; 2020)

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.

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

14 days

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.

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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
PF199 CA 19-9, Pleural Fluid 19163-5
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.
P199 CA 19-9, Pleural Fluid 19163-5
SITE8 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