Abstract:

Objective To investigate the reference intervals of serum human epididymis protein 4 （HE4） and the risk of ovarian malignancy algorithm （ROMA） index in females. Methodse Serum HE4 and carbohydrate antigen 125 （CA125） were determined by Roche Cobas E601 automatic electrochemiluminescence in 700 healthy subjects （414 cases of non-menopause and 286 cases of menopause） and 160 ovarian tumor patients （80 cases of ovarian malignant tumor and 80 cases of ovarian benign tumor）,and ROMA index was calculated according to ROMA model. The reference intervals of serum HE4 and ROMA index in females were established,and the clinical diagnostic performance of serum HE4 and ROMA index with different reference intervals was verified. Results The reference intervals of serum HE4 were <72.25 pmol/L in premenopausal females and <82.72 pmol/L in postmenopausal females. The reference intervals of ROMA index were <15.09% in premenopausal females and <21.32% in postmenopausal females. Conclusions The combined determination of CA125 and serum HE4 and ROMA index improves the diagnosis of ovarian epithelial cancer, and the establishment of serum HE4 and ROMA index reference intervals is helpful for the early diagnosis of ovarian cancer. The established reference intervals are more suitable for our laboratories than that of manufacturers.

Key words: Human epididymis protein 4, Carbohydrate antigen 125, Risk of ovarian malignancy algorithm index, Reference interval, Electrochemiluminescence, Ovarian cancer