Test ID: CEA
Carcinoembryonic Antigen (CEA), Serum
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
Monitoring colorectal cancer and selected other cancers such as medullary thyroid carcinoma
May be useful in assessing the effectiveness of chemotherapy or radiation treatment
Carcinoembryonic antigen levels are not useful in screening the general population for undetected cancers
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
Embryonic Carcinoma Antigen
Carcinoembryonic Antigen (CEA)
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.
Container/Tube:
Preferred: Serum gel
Acceptable: Red top
Specimen Volume: 0.6 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 | Mild OK; Gross reject |
| Lipemia | Mild OK; Gross OK |
| 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 |
|---|---|---|
| Serum | Refrigerated (preferred) | 7 days |
| Frozen | 90 days |
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Carcinoembryonic antigen (CEA) is a glycoprotein normally found in embryonic entodermal epithelium.
Increased levels may be found in patients with primary colorectal cancer or other malignancies including medullary thyroid carcinoma and breast, gastrointestinal tract, liver, lung, ovarian, pancreatic, and prostatic cancers.
Serial monitoring of CEA should begin prior to therapy to verify post therapy decrease in concentration and to establish a baseline for evaluating possible recurrence. Levels generally return to normal within 1 to 4 months after removal of cancerous tissue.
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.
Nonsmokers: < or =3.0 ng/mL
Some smokers may have elevated CEA, usually <5.0 ng/mL.
Serum markers are not specific for malignancy, and values may vary by method.
Interpretation Provides information to assist in interpretation of the test results
Grossly elevated carcinoembryonic antigen (CEA) concentrations (>20 ng/mL) in a patient with compatible symptoms are strongly suggestive of the presence of cancer and also suggest metastasis.
Most healthy subjects (97%) have values < or =3.0 ng/mL.
After removal of a colorectal tumor, the serum CEA concentration should return to normal by 6 weeks, unless there is residual tumor.
Increases in test values over time in a patient with a history of cancer suggest tumor recurrence.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
The concentration of carcinoembryonic antigen (CEA) in serum should not be used to screen asymptomatic individuals for neoplastic disease, and the diagnostic efficacy of CEA measurements in high-risk groups has not been established.
Single values of CEA are less informative than changes assessed over time.
CEA values are method-dependent; therefore, the same method should be used to serially monitor patients.
Do not interpret serum CEA levels as absolute evidence of the presence or the absence of malignant disease. Use serum CEA in conjunction with information from the clinical evaluation of the patient and other diagnostic procedures.
Some patients who have been exposed to animal antigens, either in the environment or as part of treatment or imaging procedures, may have circulating antianimal antibodies present. These antibodies may interfere with the assay reagents to produce unreliable results.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Chan DW, Booth RA, Diamandis EP, et al: In Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. Fourth edition. Edited by CA Burtis, ER Ashwood, DE Bruns. St. Louis, Elsevier, Inc., 2006 pp 768-769
2. Locker, GY, Hamilton S, Harris J, et al: ASCO 2006 update of recommendations for the use of tumor markers in gastrointestinal cancer. J Clin Oncol 2006;24:5313-5327
3. Moertel CG, Fleming TR, Macdonald JS, et al: An evaluation of the carcinoembryonic antigen (CEA) test for monitoring patients with resected colon cancer. JAMA 1993;270:943-947
Method Description Describes how the test is performed and provides a method-specific reference
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, Fullerton CA, 2009)
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 5 a.m. – 12 a.m., Saturday 6 a.m. – 6 p.m.
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 |
|---|---|---|
| CEA | Carcinoembryonic Ag (CEA), S | 2039-6 |
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