ROCHE ELECSYS CEA Reagent

System information

For cobas e 411 analyzer: test number 301

For MODULAR ANALYTICS E170, cobas e 601 and cobas e 602 analyzers: Application Code Number 049

Please note

The measured CEA 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 CEA assay method used. CEA 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 CEA assay procedure used while monitoring therapy, then the CEA values obtained upon changing over to the new procedure must be confirmed by parallel measurements with both methods.

Intended use

Immunoassay for the in vitro quantitative determination of carcinoembryonic antigen in human serum and plasma. This assay is further indicated for serial measurement of CEA to aid in the management of cancer patients. The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers.