Test Catalog

Test Id : CEA

Carcinoembryonic Antigen (CEA), Serum

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

 

This test is not useful for screening the general population for undetected cancers.

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

Carcinoembryonic Ag (CEA), S

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

CEA, Serum

Embryonic Carcinoma Antigen

Carcinoembryonic Antigen (CEA)

Specimen Type
Describes the specimen type validated for testing

Serum

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

Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 0.6 mL

Collection Instructions:

1. Serum gel tubes should be centrifuged within 2 hours of collection.

2. Red-top tubes should be centrifuged and aliquoted within 2 hours of collection.

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

0.5 mL

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

Gross hemolysis Reject
Gross lipemia 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
Serum Refrigerated (preferred) 7 days
Frozen 90 days

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

 

This test is not useful for screening the general population for undetected cancers.

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 suggest metastasis.

 

Most healthy subjects (97%) have values less than or equal to 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
Recommendations for in-depth reading of a clinical nature

1. Sturgeon C: Tumor markers. In: Rifai N, Horvath AR, Wittwer CT, eds: Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 6th ed. Elsevier; 2018:436-478

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: Access CEA. Beckman Coulter; 05/2020

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 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

3 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 Regional Manager. 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 cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

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.

82378

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
CEA Carcinoembryonic Ag (CEA), S 83085-1
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.
CEA Carcinoembryonic Ag (CEA), S 83085-1

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