Test Catalog

Test Id : C2729

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Breast Carcinoma-Associated Antigen, Serum

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Overview

Test Catalog

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

Aiding in the management of breast cancer in patients with metastatic disease by monitoring the progression or regression of disease in response to treatment

 

Serial testing in women with prior stage II or III breast cancer who are clinically free of disease

 

May be useful for predicting early recurrence of disease in women with treated carcinoma of the breast

 

This test is not useful for screening women for or diagnosis of carcinoma of the breast.

Highlights

The US Food and Drug Administration has approved CA 27.29 for serial testing in women with prior stage II or III breast cancer who are clinically free of disease.

Method Name
A short description of the method used to perform the test

Chemiluminometric Immunoassay

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

Breast Carcinoma Assoc Ag(CA 27.29)

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

Biomira Truquant BR

Breast Cancer Tumor Markers

Breast Carcinoma

Cancer Antigen 27.29 (CA 27.29)

MAM 6

Milk Mucin

CA2729

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

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL

Collection Instructions:

1. Centrifuge and aliquot serum into a plastic vial within 2 hours of collection. Specimens that have not been aliquoted will be canceled.

2. Send refrigerated.

Forms

If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

-General Request (T239)

-Oncology Test Request (T729)

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.25 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
Ambient 4 days

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

Aiding in the management of breast cancer in patients with metastatic disease by monitoring the progression or regression of disease in response to treatment

 

Serial testing in women with prior stage II or III breast cancer who are clinically free of disease

 

May be useful for predicting early recurrence of disease in women with treated carcinoma of the breast

 

This test is not useful for screening women for or diagnosis of carcinoma of the breast.

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

Carcinoma of the breast is the most prevalent form of cancer in women. These tumors often produce mucinous antigens, which are large-molecular-weight glycoproteins with O-linked oligosaccharide chains.

 

Monoclonal antibodies directed against these antigens have been developed, and several immunoassays are available to quantitate the levels of tumor-associated mucinous antigens in serum. The antibodies recognize epitopes of a breast cancer-associated antigen encoded by the human mucin 1 (MUC-1) gene, which is known by several names including MAM6, milk mucin antigen, cancer antigen (CA) 27.29, and CA 15-3.

 

While CA 27.29 is expressed at the apical surface of normal epithelial cells, it is present throughout malignant epithelial cells of the breast, lung, ovary, pancreas, and other sites. The cancer-associated form of the antigen is less extensively glycosylated than the normal form and more specific for tumor cells.

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.

Males

> or =18 years: < or =38.0 U/mL (use not defined)

Females

> or =18 years: < or =38.0 U/mL

Reference values have not been established for patients who are younger than 18 years of age.

Serum markers are not specific for malignancy, and values may vary by method.

Interpretation
Provides information to assist in interpretation of the test results

Increased levels of cancer-associated antigen (CA 27.29) (>38 U/mL) may indicate recurrent disease in a woman with treated breast carcinoma and may be useful as an indication that additional tests or procedures should be performed to confirm recurrence.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Measurement of CA 27.29 is not useful to screen women for carcinoma of the breast. It is NOT intended as a screening test or for diagnosis.

 

Testing for CA 27.29 should be performed in conjunction with other clinical methods used for the early detection of recurrence.

 

Normal concentrations of CA 27.29 do not always preclude the presence of disease. Do not interpret concentrations of CA 27.29 as absolute evidence of the presence or the absence of malignant disease. Before treatment, patients with confirmed breast carcinoma frequently have concentrations of CA 27.29 within the range observed in healthy individuals. Additionally, elevated concentrations of CA 27.29 can be observed in patients with nonmalignant diseases. Measurements of CA 27.29 should always be used in conjunction with other diagnostic procedures, including information from the patient’s clinical evaluation.

 

This test provides results on female patients only at this time.

 

Exercise caution when interpreting ADVIA Centaur BR 27.29 concentrations during pregnancy.

 

Heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays. Some patients who have been exposed to mouse antigens, either in the environment or as part of treatment or imaging procedure, may have circulating antimouse antibodies present. These antibodies may interfere with the assay reagents to produce unreliable CA 27.29 results.

 

The testing method is a chemiluminometric immunoassay manufactured by Siemens and performed on the Siemen’s Advia Centaur. Values obtained with different assay methods or kits may be different and cannot be used interchangeably. Test results cannot be interpreted as absolute evidence for the presence or absence of malignant disease.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Bon GG, von Mensdorff-Pouilly S, Kenemans P, van Kamp GJ, Verstraeten RA, Hilgers J. Clinical and technical evaluation of ACS BR serum assay of MUC1 gene-derived glycoprotein in breast cancer, and comparison with CA 15-3 assays. Clin Chem. 1997;43(4):585-593

2. Chan DW, Beveridge RA, Muss H. Use of Truquant BR radioimmunoassay for early detection of breast cancer recurrence in patients with stage II and stage III disease. J Clin Oncol. 1997;15(6):2322-2328

3. Lin DC, Genzen JR. Concordance analysis of paired cancer antigen (CA) 15-3 and 27.29 testing. Breast Cancer Res Treat. 2018;167(1):269-276

Method Description
Describes how the test is performed and provides a method-specific reference

Cancer antigen (CA) 27.29 is measured using an automated, competitive, chemiluminescent immunoassay. The signal (Lite) reagent is a monoclonal antibody specific for CA 27.29, which is labeled with acridinium ester. Purified CA 27.29 antigen attached to paramagnetic particles (solid phase) competes with the antigen in the specimen for binding to the monoclonal antibody. An inverse relationship exists between the amount of CA 27.29 in the patient specimen and the amount of relative light units detected by the system.(Package insert: Advia Centaur XPT CA 27.29. Siemens Healthcare Diagnostics Inc.; 11206409_EN Rev. 22, 10/2022)

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.

Same day/1 to 2 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

3 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.

  • 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.

86300

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
C2729 Breast Carcinoma Assoc Ag(CA 27.29) 17842-6
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.
C2729 Breast Carcinoma Assoc Ag(CA 27.29) 17842-6

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 | PHP Pdf | CMS 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