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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 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: Aliquot Tube, 5 mL (T465)

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.


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) 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, approved or is exempt 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 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 Jan;36:41-48

2. Geraghty JG, Coveney EC, Sherry F, O'Higgins NJ, Duffy MJ: CA 15-3 in patients with locoregional and metastatic breast carcinoma. Cancer. 1992 Dec 15;70(12):2831-2834

3. Kallioniemi OP, Oksa H, Aaran RK, Hietanen T, Lehtinen M, Koivula T: Serum CA 15-3 assay in the diagnosis and follow-up of breast cancer. Br J Cancer. 1988 Aug;58(2):213-215

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

Method Description

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 Diagnostics; V14 09/2010)

Analytic Time

1 day

Reject Due To

Gross hemolysis Reject
Gross lipemia OK

Method Name

Electrochemiluminescence Immunoassay (ECLIA)