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
May be useful in assessing the effectiveness of chemotherapy or
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.
                
            
    
    
    
        Reporting Name
            
                
                
                    
                    Lists a shorter or abbreviated version of the Published Name for a test
                
            
    
    
    
        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
Submission Container/Tube: Plastic vial
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 the serum aliquoted into a plastic vial 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. 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 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
May be useful in assessing the effectiveness of chemotherapy or
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 
Increased levels may be found in patients with primary colorectal
 
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 
    
        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
Single values of CEA are less informative than changes assessed
CEA values are method-dependent; therefore, the same method 
Do not interpret serum CEA levels as absolute evidence of the 
Some patients who have been exposed to animal antigens, either
    
        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 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
                
            
    
    
    
        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.
                
            
    
    
    
        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
            
                
                
                    
                    Indicates the location of the laboratory that performs the test
                
            
    
    
    
        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 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.
                
            
    
    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.
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|---|---|---|
| CEA | Carcinoembryonic Ag (CEA), S | 83085-1 |