Cancer Antigen 15-3 (CA 15-3), Serum
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
The management of breast cancer patients when used in conjunction with clinical information and other diagnostic procedures. Serial testing can 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
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Cancer Ag 15-3, (CA 15-3), S
CA 15-3 (Cancer Antigen 15-3)
Mucin-Like Carcinoma-Associated Antigen
Mucin-Like Carcinoma-Associated Antigen
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Preferred: Red top
Acceptable: Serum gel
Specimen Volume: 0.5 mL
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Mild OK; Gross reject
Mild OK; Gross OK
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|Serum||Refrigerated (preferred)||7 days|
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Carcinoma of the breast is the most prevalent form of cancer in women. These tumors often produce mucinous antigens that are large molecular weight glycoproteins with O-linked oligosaccharide chains. Tumor-associated antigens encoded by the human MUC-1 gene are known by several names, including MAM6, milk mucin antigen, cancer antigen (CA) 27.29, and CA 15-3.
CA 15-3 assay values are not elevated in most normal individuals and are frequently elevated in sera from breast cancer patients.
Nonmammary malignancies in which elevated CA 15-3 assay values have been reported include: lung, colon, pancreas, primary liver, ovary, cervix, and endometrium.
Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
Males: <30 U/mL (use not defined)
Females: <30 U/mL
Increasing and decreasing values show correlation with disease progression and regression, respectively.(1) Increasing cancer antigen 15-3 (CA 15-3) assay values in patients at risk for breast cancer recurrence after primary therapy may be indicative of recurrent disease before it can be detected clinically (2,3) and may be used as an indication that additional tests or procedures should be performed.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Testing for cancer antigen 15-3 (CA 15-3) should be performed in conjunction with other clinical methods used for the early detection of recurrence.
Measurement of CA 15-3 is not useful as a cancer-screening test.
Some patients, who have been exposed to mouse antigens, whether in the environment or as part of treatment or imaging procedures, may have circulating antimouse antibodies. These antibodies may interfere with the assay reagents to produce unreliable CA 15-3 assay results
Wait at least 8 hours after the last biotin administration before drawing a specimen from patients receiving therapy with high doses of biotin (ie, >5 mg/day) to avoid assay interference.
In rare cases, interference due to extremely high titers of antibodies to ruthenium or streptavidin can occur.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Molina R, Zanon G, Filella X, et al: Use of serial carcinoembryonic antigen and CA 15-3 assays in detecting relapses in breast cancer patients. Breast Cancer Res Treat 1995;36:41-48
2. Geraghty JG, Coveney EC, Sherry F, et al: CA 15-3 in patients with locoregional and metastatic breast carcinoma. Cancer 1992;70:2831-2834
3. Kallioniemi OP, Oksa H, Aaran RK, et al: Serum CA 15-3 assay in the diagnosis and follow-up of breast cancer. Br J Cancer 1988;58:213-215
Method Description Describes how the test is performed and provides a method-specific reference
The instrument used is the Roche Cobas. The Roche cancer antigen 15-3 (CA 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: Roche CA 15-3 reagent, Roche Diagnostic Corp., Indianapolis, IN 2010-09, V14)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Friday; 5 a.m.-12 a.m.
Saturday; 6 a.m.-6 p.m.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
This test has been cleared or approved by the U.S. 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 Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|
|CA153||Cancer Ag 15-3, (CA 15-3), S||6875-9|