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Test Code CA153 / CA153-M 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

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, 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.

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.

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)

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 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.


Method Name

Electrochemiluminescence Immunoassay (ECLIA)