Useful For
Immunological in vitro assay for quantitative determination of CA 15-3 in human serum and plasma to aid in the management of breast cancer patients. In conjunction with other clinical and diagnostic procedures, serial testing with this assay is an aid
• in the early detection of recurrence in previously treated stage II and III breast cancer patients
• for monitoring response to therapy in metastatic breast cancer patients
• The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers.
Method Name
Roche electrochemiluminescence immunoassay “ECLIA”. The measured CA 15-3 value of a patient’s sample can vary depending on the testing procedure used. CA 15-3 values determined on patient samples by different testing procedures cannot be directly compared with one another and could be the cause of erroneous medical interpretations.
If there is a change in the CA 15-3 assay procedure used while monitoring therapy, then the CA 15-3 values obtained upon changing over to the new procedure must be confirmed by parallel measurements with both methods.
Important Note
The measured CA 15-3 value of a patient’s sample can vary depending on the testing procedure used. CA 15-3 values determined on patient samples by different testing procedures cannot be directly compared with one another and could be the cause of erroneous medical interpretations.
If there is a change in the CA 15-3 assay procedure used while monitoring therapy, then the CA 15-3 values obtained upon changing over to the new procedure must be confirmed by parallel measurements with both methods.
Aliases
CA 15-3, CA 15-3 GFH, Cancer Antigen 15-3,, CA 15-3 GFH
Specimen Type
Plasma or Serum
Specimen Required
Lithium heparin plasma separator tube is preferred but serum separator tube (SST) is also acceptable. If using an SST, please allow 20 minutes after collection for specimen to clot before centrifugation. All specimens must be centrifuged within four hours of collection.
Specimen Minimum Volume
1.0 mL blood
Specimen Stability Information
Centrifuged specimen is stable 5 days refrigerated
Special Instructions
Samples should not be taken from patients receiving therapy with high biotin doses (i.e. > 5 mg/day) until at least 8 hours following the last biotin administration.
Performing Laboratory
Glens Falls Hospital Chemistry and Special Chemistry Department
Reference Values
Less than or equal to 25 U/mL
Day(s) and Time(s) Performed
As ordered. Turn around time four hours
Specimen Retention Time
72 hours