System information

For cobas e 411 analyzer: test number 341

For cobas e 601 and cobas e 602 analyzers: Application Code Number 053

Please note

The measured CA 125 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 125 assay method used. CA 125 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 125 assay procedure used while monitoring therapy, then the CA 125 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 OC 125 reactive determinants in human serum and plasma. These determinants are associated with a high molecular weight glycoprotein in serum and plasma of women with primary epithelial invasive ovarian cancer (excluding those with cancer of low malignant potential). This assay is indicated for use as an aid in the detection of residual or recurrent ovarian carcinoma in patients who have undergone first‑line therapy and would be considered for second-look procedures. This assay is further indicated for serial measurement of CA 125 to aid in the management of cancer patients. This assay is also intended to be used in conjunction with the Elecsys HE4 assay as part of ROMA (Risk Of Ovarian Malignancy Algorithm) for the risk assessment of ovarian cancer in premenopausal and postmenopausal women presenting with pelvic mass. The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers.