Specimen:
Collect
- One SST
Also Acceptable:
- One Green Top (Li Heparin)
- One Green Top (Na Heparin)
- One Lavender (EDTA)
- One Pink Top (EDTA)
- One Red Top
Submit
- 1 mL (Min:0.5 mL) Serum . Submit Refrigerated. Submit in a Standard Transport Tube.
Also Acceptable:
- 1 mL (Min:0.5 mL) Plasma . Submit Refrigerated. Submit in a Standard Transport Tube.
Special Handling
- Allow specimen to clot completely at room temperature
- For patients receiving therapy with high biotin doses (>5 mg/day), no laboratory test specimen should be collected until at least 8 hours after the last biotin administration.
Stability
Ambient: 2 Day(s); Refrigerated: 5 Day(s); Frozen: 3 Month(s); Incubated: Unacceptable
Methodology
- Electrochemiluminescence Immunoassay (ECLIA)
Performed
Mon-Fri
Reported
1-3 Day(s)
CPT Codes
- 86300
Interpretive Data
General Reference Range : 0-25.0 U/mL
The Roche e801 CA 15-3 electrochemiluminescent immunoassay is used. Results obtained with different methods or kits cannot be used interchangeably. The CA 15-3 assay is used to aid in the management of Stage II and III breast cancer patients. Serial testing for patient CA 15-3 assay values should be used in conjunction with other clinical methods for monitoring breast cancer. Patients with confirmed breast carcinoma frequently have CA 15-3 assay values in the same range as healthy individuals. Elevations may be observed in patients with nonmalignant disease. For these reasons, a CA 15-3 assay value, regardless of level, should not be interpreted as absolute evidence of the presence or absence of malignant disease.
Biotin in specimens taken from patients on high-dose biotin therapy or supplements may intefere with this test and cause inaccurate test results. It is recommended that for patients receiving therapy with high biotin doses (> 5 mg/day), no laboratory test specimen should be collected until at least 8 hours after the last biotin administration.
The Roche e801 CA 15-3 electrochemiluminescent immunoassay is used. Results obtained with different methods or kits cannot be used interchangeably. The CA 15-3 assay is used to aid in the management of Stage II and III breast cancer patients. Serial testing for patient CA 15-3 assay values should be used in conjunction with other clinical methods for monitoring breast cancer. Patients with confirmed breast carcinoma frequently have CA 15-3 assay values in the same range as healthy individuals. Elevations may be observed in patients with nonmalignant disease. For these reasons, a CA 15-3 assay value, regardless of level, should not be interpreted as absolute evidence of the presence or absence of malignant disease.
Biotin in specimens taken from patients on high-dose biotin therapy or supplements may intefere with this test and cause inaccurate test results. It is recommended that for patients receiving therapy with high biotin doses (> 5 mg/day), no laboratory test specimen should be collected until at least 8 hours after the last biotin administration.
Components
- 2629 - CA 15-3
Last Updated: May 11, 2025 @ 9:13 am
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