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


Specimen Required


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

Supplies: Sarstedt 5 mL Aliquot Tube (T914)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions: Centrifuge and aliquot serum into plastic vial.


Useful For

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

 

Serial testing to 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

 

This test is not useful as a cancer screening test.

Method Name

Electrochemiluminescence Immunoassay (ECLIA)

Reporting Name

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

Specimen Type

Serum

Specimen Minimum Volume

0.75 mL

Specimen Stability Information

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

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. 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.

Reference Values

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

Females: <30 U/mL

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.

 

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.

 

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

Day(s) Performed

Monday through Friday

Report Available

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

NY State Approved

Yes