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Cancer Antigen 15-3 (CA 15-3), Serum

Important Note

Test subject to Medicare National Coverage Determination (NCD) 190.29 Tumor Antigen by Immunoassay CA15-3/CA 27.29.

Additional Codes

Epic Code Atlas Code Mayo Test ID Order LOINC Legacy Code
LAB2454 CA153 CA153 83083-6 CA153

 

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.

Method Name

Electrochemiluminescence Immunoassay (ECLIA)

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Serum


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.


Specimen Minimum Volume

0.75 mL

Specimen Stability Information

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

Reject Due To

Gross hemolysis Reject
Gross lipemia OK

Reference Values

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

Females: <30 U/mL

Day(s) Performed

Monday through Saturday

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

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.

Report Available

1 to 3 days

Specimen Retention Time

2 weeks

NY State Approved

Yes

Forms

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