Ordering Recommendation

Monitor therapy and identify disease recurrence in individuals with metastatic breast cancer. Do not use for diagnosis or screening of breast cancer.

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation
Collect

Serum separator tube or plasma separator tube. Also acceptable: Green (lithium heparin), lavender (K2EDTA), or pink (K2EDTA).

Specimen Preparation

Allow specimen to clot completely at room temperature. Separate serum or plasma from cells ASAP or within 2 hours of collection. Transfer 1 mL serum or plasma to an ARUP Standard Transport Tube. (Min: 0.5 mL)

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions
Remarks
Stability

After separation from cells: Ambient: 48 hours; Refrigerated: 5 days; Frozen: 3 months

Methodology

Quantitative Electrochemiluminescent Immunoassay

Performed

Sun-Sat

Reported

Within 24 hours

Reference Interval

0-31 U/mL

Interpretive Data

The Roche CA 15-3 electrochemiluminescent immunoassay is used. Results obtained with different methods or kits cannot be used interchangeably. The CA 15-3 test is used to aid in the management of Stage II and III breast cancer patients. Serial testing for patient CA 15-3 values should be used in conjunction with other clinical methods for monitoring breast cancer. Patients with confirmed breast carcinoma frequently have CA 15-3 values in the same range as healthy individuals. Elevations may be observed in patients with nonmalignant disease. Therefore, a CA 15-3 value, regardless of level, should not be interpreted as absolute evidence of the presence or absence of malignant disease.

Compliance Category

FDA

Note

Hotline History

N/A

CPT Codes

86300

Components

Component Test Code* Component Chart Name LOINC
0080464 Cancer Antigen-Breast (CA15-3) 6875-9
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

  • CA 15-3
  • CA-Breast
  • CA153
  • Cancer Antigen-Breast
  • MUC-1
  • Mucin-Like Carcinoma-Associated Antigen
Cancer Antigen-Breast (CA 15-3)