Determination of reference intervals of serum levels of human epididymis protein 4 (HE4) in Chinese women

Abstract

BackgroundTo determine reference intervals for serum levels of human epididymis protein 4 (HE4) in Chinese women.MethodsIn this multicenter (n = 9) study, 618 healthy women, 767 patients with non-malignant diseases, and 951 patients with malignant tumors were enrolled. Serum levels of HE4 were measured in all patients using electrochemiluminescence immunoassays. The influence of age, menopause, malignancy status and other characteristics on the levels of HE4 was evaluated using univariate and multivariate analyses. Confidence intervals (2.5–97.5 %) were determined in different populations.ResultsThere were significant differences in HE4 levels among groups with different ages, menopause or malignancy status. Higher levels of HE4 were detected in elder compared to younger, post- compare to pre- menopause and malignant compared to benign subjects. Multivariate analysis showed that menopause and malignancy status, as well as smoking and pelvic masses were independent factors involved in serum HE4 levels. In pre-menopause stage, the reference ranges of HE4 level were 29.30–68.79, 28.12–1284.83 and 34.75–981.91 pmol/L in healthy, benign and malignant populations, respectively. In post-menopause stage, the reference ranges are 35.96–114.43, 39.11–2208.70 and 39.40–1678.13 pmol/L for those populations.ConclusionsThe present study has established the reference intervals of HE4 levels in pre- and post-menopause populations with different malignancy status.Electronic supplementary materialThe online version of this article (doi:10.1186/s13048-015-0201-z) contains supplementary material, which is available to authorized users.

Comparison of HE4, CA125, and ROMA Diagnostic Accuracy

“…Recently, human epididymis secretary protein 4 (HE4) emerged as 1 of the most promising biomarker for the diagnosis of epithelial ovarian cancer (EOC). 8 It is demonstrated to be overexpressed in ovarian carcinomas but not in the normal ovary tissue. Its SN was similar to CA125, but an increased diagnostic SP.…”

Physiopathological factors affecting the diagnostic value of serum HE4-test for gynecologic malignancies

“…The authors concluded that HE4 levels may not be related to menopausal status, but age is an important factor that caused the most notable increase, especially for women after age 79 years. Recently, Tian et al reported a multicenter study in nine Chinese hospitals that enrolled 618 healthy women, 767 patients with nonmalignant disease and 951 patients with malignant disease [37]. Multivariate analysis showed that menopause but not age was an independent factor involved in serum HE4 levels.…”

Human Epididymis Protein 4 (HE4) Reference Limits in Polish Population of Healthy Women, Pregnant Women, and Women with Benign Ovarian Tumors

“…Another study, published in 2015, attempted to define HE4 reference ranges within a Chinese study population and found the norm to be between 29.30 pmol/l and 68.79 pmol/l for premenopausal women and between 35.96 pmol/l and 114.43 pmol/l for postmenopausal women [9].…”