Test ID: PFCEA
Carcinoembryonic Antigen (CEA), Pleural Fluid
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
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
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
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: 2 mL
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 |
|---|---|---|
| Pleural Fluid | Frozen (preferred) | 90 days |
| Ambient | 7 days | |
| Refrigerated | 7 days |
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, often requiring cytological examination of the pleural fluid and imaging studies of the pleural tissue. 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 and imaging findings.
Carcinoembryonic antigen (CEA) is a glycoprotein produced during fetal development. Nonsmoking, healthy adults typically produce low to undetectable levels of CEA. Serum concentrations of CEA may be elevated in patients with certain malignancies that secrete CEA into circulation, including medullary thyroid carcinoma and breast, gastrointestinal tract, colorectal, liver, lung, ovarian, pancreatic, and prostate cancers.
Pleural fluid concentrations of CEA have been reported to be elevated in patients with certain malignancies. Malignancies that can secrete CEA and elevate serum CEA concentrations, including lung, breast, ovarian, gastrointestinal, and colorectal cancers, typically also elevate CEA in pleural fluid. In contrast, malignancies that do not secrete CEA, including mesothelioma, lymphoma, leukemia, and melanoma, have low concentrations of CEA in pleural fluid comparable to concentrations observed in non-malignant effusions.
Elevated CEA concentrations in pleural fluid have also been reported with certain nonmalignant conditions, including liver cirrhosis, pancreatitis, complicated parapneumonic effusions and empyemas, and rarely with tuberculosis.
CEA 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 carcinoembryonic antigen (CEA) concentration of > or =3.5 ng/mL is suspicious but not diagnostic of a malignant source of the effusion. This cutoff yielded a sensitivity of 52%, specificity of 95%, and part per volume of 93% in a study of 200 patients presenting with effusion. CEA concentrations were significantly higher in effusions caused by CEA-secreting malignancies, including lung, breast, ovarian, gastrointestinal, and colorectal cancers. However, effusions caused by non-CEA-secreting malignancies, including lymphoma, mesothelioma, leukemia, and melanoma, routinely had CEA concentrations <3.5 ng/mL. Therefore, negative results should be interpreted with caution, especially in patients who have or are suspected of having a non-CEA-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. Carcinoembryonic antigen (CEA) and other tumor markers are not specific for malignancy and CEA 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 CEA result may be misleading, as certain malignancies do not secrete CEA and will not produce elevated CEA concentrations in pleural effusions. Negative results should be interpreted with caution in patients who have or are suspected of having a non-CEA-secreting malignancy or who have a cancer of unknown primary origin. Alternative methodologies, including cytology, imaging, and other tumor markers should be considered.
CEA concentrations have been reported to be elevated in pleural fluid as a consequence of certain nonmalignant conditions, including liver cirrhosis, pancreatitis, complicated parapneumonic effusions and empyemas, and rarely with tuberculosis. Results should be interpreted with caution in patients with those conditions.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Shitrit D, Zingerman B, Shitrit AB, et al: 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;10:501-507
2. Hackbarth JS, Murata K, Reilly W, 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. Garcia-Pachon E, Padilla-Navas I, Dosda MD, Miralles-Llopis A: Elevated level of carcinoembryonic antigen in nonmalignant pleural effusions. Chest 1997;111:643-647
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 CEA assay is a 2-site immunoenzymatic sandwich assay using mouse monoclonal anti-carcinoembryonic antigen (CEA) antibodies that react with different epitopes of CEA. A sample is added to a reaction vessel, along with the first anti-CEA monoclonal antibody-alkaline phosphatase conjugate and the second anti-CEA monoclonal antibody 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, 2008)
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.
82378
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 |
|---|---|---|
| PCEA | CEA, Pleural Fluid | N/A |
| SITE9 | Site | N/A |
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