System information

For cobas e 411 analyzer: test number 1000 For MODULAR ANALYTICS E170, cobas e 601 and cobas e 602 analyzers: Application Code Number 281

Intended use

Immunoassay for the quantitative determination of HE4 in human serum and plasma. The assay is used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer. Serial testing for patient HE4 values should be used in conjunction with other clinical findings used for monitoring ovarian cancer. It is further intended to be used in conjunction with the Elecsys CA 125 II assay as an aid in estimating the risk of epithelial ovarian cancer in premenopausal and postmenopausal women presenting with pelvic mass. The results must be interpreted in conjunction with other methods in accordance with standard clinical management guidelines. The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers.