电化学发光法检测血清HE4、ROMA指数参考区间分析

Reference intervals of serum HE4 and ROMA index determined by electrochemiluminescence

目的研究女性人群血清人附睾蛋白4(HE4)和卵巢癌风险预测(ROMA)指数的参考区间。方法采用罗氏Cobas E601全自动电化学发光仪检测700名健康体检者(未绝经者414名,绝经者286名)和160例卵巢肿瘤患者(卵巢恶性肿瘤80例,卵巢良性肿瘤80例)血清HE4、糖类抗原125(CA125)水平,根据ROMA模型计算ROMA指数。建立电化学发光法女性人群血清HE4和ROMA指数的参考区间,对血清HE4和ROMA指数不同参考区间的临床诊断性能进行验证。结果血清HE4水平参考区间为:绝经前HE4<72.25 pmol/L,绝经后HE4<82.72 pmol/L。ROMA指数参考区间为:绝经前<15.09%,绝经后<21.32%。结论 CA125与HE4的联合检测及ROMA指数提高了卵巢上皮癌诊断的准确性,HE4与ROMA指数参考区间的设立更有助于发现早期卵巢癌。研究建立的参考区间比厂家提供的参考区间更适合本实验室。

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.