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HelpTest Code CA153 Cancer Antigen 15-3 (CA 15-3), Serum
Reporting Name
Cancer Ag 15-3, (CA 15-3), SUseful 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
SerumSpecimen 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 |
Method Description
The Roche CA 15-3 (cancer antigen 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: Elecsys CA 15-3 II. Roche Diagnostics; V 4.0, 07/2024)
Report Available
1 to 3 daysReject 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)
Forms
If not ordering electronically, complete, print, and send an Oncology Test Request (T729) with the specimen.