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Test Code CA153 Cancer Antigen 15-3 (CA 15-3), Serum

Important Note

Test subject to Medicare National Coverage Determination (NCD).

See Medical Necessity documentation requirements by clicking on  

Medicare National Coverage Determinations under General Information

to left of this screen.

Reporting Name

Cancer Ag 15-3, (CA 15-3), S

Useful For

Managing breast cancer patients when used in conjunction with clinical information and other diagnostic procedures

 

Serial testing can assist in early detection of disease recurrence in previously treated stage II and III breast cancer patients

 

Monitoring response to therapy in metastatic breast cancer patients

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Serum

Specimen Minimum Volume

0.45 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum Refrigerated (preferred) 7 days
  Frozen  90 days

Reference Values

Males: <30 U/mL (use not defined)

Females: <30 U/mL

Day(s) and Time(s) Performed

Monday through Friday; 5 a.m.-12 a.m.

Saturday; 6 a.m.-6 p.m.

Test Classification

This test has been cleared or approved by the U.S. 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
CA153 Cancer Ag 15-3, (CA 15-3), S 83083-6

 

Result ID Test Result Name Result LOINC Value
CA153 Cancer Ag 15-3, (CA 15-3), S 83083-6

Clinical Information

Carcinoma of the breast is the most prevalent form of cancer in women. These tumors often produce mucinous antigens that are large molecular weight glycoproteins with O-linked oligosaccharide chains. Tumor-associated antigens encoded by the human MUC-1 gene are known by several names, including MAM6, milk mucin antigen, cancer antigen (CA) 27.29, and CA 15-3.

 

CA 15-3 assay values are not elevated in most normal individuals and are frequently elevated in sera from breast cancer patients.

 

Nonmammary malignancies in which elevated CA 15-3 assay values have been reported include: lung, colon, pancreas, primary liver, ovary, cervix, and endometrium.

Interpretation

Increasing and decreasing values show correlation with disease progression and regression, respectively.(1) Increasing cancer antigen 15-3 (CA 15-3) assay values in patients at risk for breast cancer recurrence after primary therapy may be indicative of recurrent disease before it can be detected clinically (2,3) and may be used as an indication that additional tests or procedures should be performed.

Cautions

Testing for cancer antigen 15-3 (CA 15-3) should be performed in conjunction with other clinical methods used for the early detection of recurrence.

 

Measurement of CA 15-3 is not useful as a cancer screening test.

 

Some patients, who have been exposed to mouse antigens, whether in the environment or as part of treatment or imaging procedures, may have circulating antimouse antibodies. These antibodies may interfere with the assay reagents to produce unreliable CA 15-3 assay results

 

Twelve hours before this blood test do not take multivitamins or dietary supplements containing biotin or vitamin B7, which are commonly found in hair, skin, and nail supplements and multivitamins.

 

In rare cases, interference due to extremely high titers of antibodies to ruthenium or streptavidin can occur.

Clinical Reference

1. Molina R, Zanon G, Filella X, et al: Use of serial carcinoembryonic antigen and CA 15-3 assays in detecting relapses in breast cancer patients. Breast Cancer Res Treat 1995;36:41-48

2. Geraghty JG, Coveney EC, Sherry F, et al: CA 15-3 in patients with locoregional and metastatic breast carcinoma. Cancer 1992;70:2831-2834

3. Kallioniemi OP, Oksa H, Aaran RK, et al: Serum CA 15-3 assay in the diagnosis and follow-up of breast cancer. Br J Cancer 1988;58:213-215

Method Description

The instrument used is the Roche Cobas. The Roche cancer antigen 15-3 (CA 15-3) method is a sandwich electrochemiluminescence immunoassay that employs a biotinylated monoclonal CA 15-3-specific antibody and a monoclonal CA 15-3-specific antibody. CA 15-3 in the automatically prediluted specimen reacts with both the biotinylated monoclonal CA 15-3-specific antibody (mouse) and the monoclonal CA 15-3-specific antibody (mouse) labeled with a ruthenium complex, forming a sandwich complex. Streptavidin-coated microparticles are added and the mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of voltage to the electrode induces the chemiluminescent emission, which is then measured.(Package insert: Roche CA 15-3 reagent, Roche Diagnostic Corp., Indianapolis, IN 2010-09, V14)

Analytic Time

1 day

Specimen Retention Time

3 months

Reject Due To

Hemolysis

Mild OK; Gross reject

Lipemia

Mild OK; Gross OK

Icterus

NA

Other

NA

 

NY State Approved

Yes


Specimen Required


Patient Preparation: For 12 hours before this test do not take multivitamins or dietary supplements containing biotin (vitamin B7), which is commonly found in hair, skin, and nail supplements and multivitamins.

Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 0.5 mL


Method Name

Electrochemiluminescence Immunoassay

Disease States

  • Breast cancer