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

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 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.

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Serum

Specimen Minimum Volume

0.75 mL

Specimen Stability Information

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

Reference Values

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

Females: <30 U/mL

Day(s) Performed

Monday through Saturday

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

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.

Report Available

1 to 3 days

Reject Due To

Gross hemolysis Reject
Gross lipemia OK


Specimen Required


Patient Preparation: For 12 hours before specimen collection, patient should not take multivitamins or dietary supplements (eg, hair, skin, and nail supplements) containing biotin (vitamin B7).

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 a plastic vial.


Method Name

Electrochemiluminescence Immunoassay (ECLIA)

Disease States

  • Breast cancer

Forms

If not ordering electronically, complete, print, and send an Oncology Test Request (T729) with the specimen.