System information

For cobas e 411 analyzer: test number 332

For cobas e 601 and cobas e 602 analyzers: Application Code Number 052

Please note

The measured CA 15‑3 value of a patient’s sample can vary depending on the testing procedure used. The laboratory finding must therefore always contain a statement on the CA 15‑3 assay method 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.

Intended use

 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.