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Test Code C2729 Breast Carcinoma-Associated Antigen, Serum

Useful For

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.

Disease States

  • Breast cancer

Method Name

Chemiluminometric Immunoassay

Reporting Name

Breast Carcinoma Assoc Ag(CA 27.29)

Specimen Type

Serum


Specimen Required


Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL

Collection Instructions:

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

2. Send refrigerated.


Specimen Minimum Volume

0.25 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 7 days
  Frozen  90 days
  Ambient  4 days

Reject Due To

Gross hemolysis Reject
Gross lipemia OK

Clinical Information

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

Males

≥18 years: ≤38.0 U/mL (use not defined)

Females

≥18 years: ≤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

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

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.

Method Description

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)

Day(s) Performed

Monday through Friday

Report Available

Same day/1 to 3 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

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

86300

LOINC Code Information

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