人附睾蛋白4时间分辨荧光免疫分析在妇科肿瘤诊断中的价值  

Value of human epididymis protein 4 in time resolved immunoassay for detection of gynecologic cancers

作　　者：张艺[1] 陈道桢[2] 王珂[3] 许飞[2] 赵军[2] 黄飚[1] 张珏[1] 范俊[1] 周彬[1] 

机构地区：[1]江苏省原子医学研究所卫生部核医学重点实验室江苏省分子核医学实验室,江苏省无锡市214063 [2]江苏省无锡市妇幼保健院,214002 [3]江苏省江阴市人民医院,214400

出　　处：《实用医学杂志》2017年第5期793-796,共4页The Journal of Practical Medicine

基　　金：江苏省卫生计生委科研课题(编号:H201637);江苏省社会发展基金项目(编号:BE2009631)

摘　　要：目的:建立人附睾蛋白4(HE4)时间分辨荧光免疫分析(TRFIA),探讨血清HE4检测在妇科肿瘤诊断中的价值。方法:采用铕标记示踪,构建HE4的双抗体夹心TRFIA,并检测了225例受试者血清HE4水平,分析血清HE4在妇科肿瘤中的诊断意义,并探讨诊断子宫内膜癌、卵巢癌及宫颈癌的最佳参考值。结果:HE4 TRFIA工作线性范围10~10 000 pmol/L,灵敏度7.5 pmol/L,与CA125和CA199无交叉反应,批间变异系数小于10%,与化学发光法检测结果一致。子宫内膜癌、卵巢癌及宫颈癌组的血清HE4水平明显高于健康对照组,子宫肌瘤组与健康对照组无显著差异;随年龄增长,妇科良恶性肿瘤的患病风险增加。HE4在上述恶性肿瘤检测中ROC^(AUG)>0.5,运用本方法测定的参考值为60 pmol/L。结论:建立了稳定、准确的HE4 TRFIA,有助于妇科肿瘤的诊断。Objective To establish a time resolved fluoroimmunoassay （TRFIA） for detecting human epididymis protein 4 （HE4） and to evaluate the diagnostic value of serum HE4 for gynecologic cancers. Methods Using Eu3. as a tracer, a sandwich-type assay was established. HE4 in serum specimens from 225 patients were detected by TRFIA. Serum levels of HE4 in pelvic tumors were quantitatively analyzed. From receiver operating characteristic （ROC） curves, the reference values was calculated for endometrial cancer, cervical cancer and ovarian cancer, respectively. Results The working range of serum HE4 for TRFIA was 10 ~ 10 000 pmol/L with a sensitivity of 7.5 pmol/L. The method offered less interaction with CA125 and CA199, and also provided a better correlation with ECLA, while the CV of intra- assay was below 10%. HE4 levels were significantly higher in endometrial cancer, cervical cancer and ovarian cancer groups than in healthy volunteer group, while did not differ significantly between uterine fibroid group and healthy women group. As aging, the risk for developing pelvic tumors increased. The area of ROC for malignant tumors was all above 0.5 and the accurate interpretation of HE4 was 60 pmol/L. Conclusion A stable, precise HE4 TRFIA is well established, which is helpful in diagnosis of gynecologic cancers.

关 键 词：子宫内膜肿瘤 卵巢肿瘤 宫颈肿瘤 人附睾蛋白4 时间分辨荧光免疫分析 

分 类 号：R737.3[医药卫生—肿瘤]