The HE4 EIA is an enzyme immunoassay for the quantitative analysis of HE4 in human serum. It is intended as a diagnostic tool for monitoring the therapeutic response of patients with invasive epithelial ovarian cancer.
A series of tests to determine HE4 values in patients should be used in parallel with other clinical methods for monitoring ovarian cancer.
The HE4 EIA test is also intended to complement the ARCHITECT CA 125 II or CanAg CA125 EIA tests for estimating the risk of epithelial ovarian cancer in premenopausal or postmenopausal women with pelvic masses.
Results should be interpreted in conjunction with other methods, in accordance with standard clinical management guidelines.