System information

For cobas e 411 analyzer: test number 351

For cobas e 601 and cobas e 602 analyzers: Application Code Number 054

Please note

The measured CA 19‑9 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 19‑9 assay method used. CA 19‑9 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 19‑9 assay procedure used while monitoring therapy, then the CA 19‑9 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 CA 19‑9 in human serum and plasma. The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers