Cautions

Results cannot be interpreted as absolute evidence of the presence or absence of malignant ovarian disease, because mild elevations of human epididymis protein 4 (HE4) might also be present in individuals with benign gynecologic conditions (ovarian cysts, cystadenomas, leiomyomas, myomas, fibromas, and endometriosis), hypertension, congestive heart failure, and renal or liver disease.

Serial testing for patient HE4 results should be used in conjunction with other clinical methods for monitoring ovarian cancer.

The use of this test in disease states other than ovarian cancer has not been clinically validated.

Serum markers are not specific for malignancy and values may vary by method. Values obtained with different assay methods cannot be used interchangeably. Correlation studies between this method and the previous ELISA method show good correlation (correlation coefficient =0.92). However this method will, on average, give 28% higher HE4 concentrations and individual patient results may vary more than would be calculated from the correlation equation.

Ideally, when changing methods, parallel testing using the old and new method allows for establishing the patient's HE4 baseline levels with the new method (rebaseline).

In rare cases, interference due to extremely high titers of antibodies to analyte-specific reagents (human anti-mouse or heterophile antibodies, streptavidin, or ruthenium) can occur. The laboratory should be alerted if the result does not correlate with the clinical presentation.