Abstract

Objective To investigate the reference range of serum human epididymis protein 4 ( HE4 ) . Methods An Enzyme-linked immunosorbent assay ( ELISA) was used to measure the concentrations of HE4. Totally 530 cases of healthy adults and benign disease patients were determined . The impact of age, sex, menopause status and diseases on serum HE4 levels was analyzed. Then the reference range was established in the north of China Results The serum HE4 levels had a positive correlation with age (r=0. 473,P 50 years[ (32. 9 ± 15. 2) pmol/L]. The serum levels of HE4 in the group of female age≤40 years [ (41. 6 ± 10. 4) pmol/L] is lower than that in the group of the female age >40 years[(32. 8 ±13.4) pmol/L]. Serum level of HE4 was higher in benign disease group as compared with that in health group in both gender and all age groups. The upper and 101. 8 pmol/L respectively. The upper limit of reference range for female in the groups of age≤40 years and age > 40 years is 59. 6 pmol/L and 62.4 pmol/L respectively. Conclusions Age and disorder are two important factors which can affect human serum level of HE4. The age should take into consideration for establishment of HE4 reference range. Key words: Epididymis secretory protein; Tumor markers; biological; Reference values

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