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Recommendations when to order or not order the test. May include related or preferred tests.
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
Indicates whether a test has been approved by the New York State Department of Health.
This test is New York state approved.
Specimen Required
Patient PreparationInstructions patient must follow before/during specimen collection.
CollectSpecimen type to collect. May include collection media, tubes, kits, etc.
Serum separator tube or plasma separator tube. Also acceptable: Green (lithium heparin), lavender (K2EDTA), or pink (K2EDTA).
Specimen PreparationInstructions for specimen prep before/after collection and prior to transport.
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 TemperaturePreferred temperatures for storage prior to and during shipping to ARUP. See Stability for additional info.
Refrigerated.
Unacceptable ConditionsCommon conditions under which a specimen will be rejected.
RemarksAdditional specimen collection, transport, or test submission information.
StabilityAcceptable times/temperatures for specimens. Times include storage and transport time to ARUP.
After separation from cells: Ambient: 48 hours; Refrigerated: 5 days; Frozen: 3 months
Methodology
Process(es) used to perform the test.
Quantitative Electrochemiluminescent Immunoassay
Performed
Days of the week the test is performed.
Sun-Sat
Reported
Expected turnaround time for a result, beginning when ARUP has received the specimen.
Within 24 hours
Reference Interval
Normal range/expected value(s) for a specific disease state. May also include abnormal ranges.
0-31 U/mL
Interpretive Data
May include disease information, patient result explanation, recommendations, or details of testing.
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
Additional information related to the test.
Hotline History
N/A
CPT Codes
The American Medical Association Current Procedural Terminology (CPT) codes published in ARUP's Laboratory Test Directory are provided for informational purposes only. The codes reflect our interpretation of CPT coding requirements based upon AMA guidelines published annually. CPT codes are provided only as guidance to assist clients with billing. ARUP strongly recommends that clients confirm CPT codes with their Medicare administrative contractor, as requirements may differ. CPT coding is the sole responsibility of the billing party. ARUP Laboratories assumes no responsibility for billing errors due to reliance on the CPT codes published.
* 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.
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