目的 探讨全自动电化学发光免疫分析法(ECLIA)和化学发光微粒子免疫法(CMIA)检测人血清附睾蛋白4(HE4)对卵巢癌的诊断价值。方法 收集39例卵巢癌、63例卵巢良性疾病和50名体检健康者血清。分别采用 ECLIA和CMIA法检测血清HE4，评估两种检测方法对卵巢癌的诊断价值。结果 两种方法测定的HE4值，呈高度正相关(r=0.997，P<0.01)；卵巢癌组HE4水平均显著高于同种方法检测的卵巢良性疾病组和体检健康人群组, 差异具有统计学意义(P<0.01)；以卵巢良性疾病为对照，ECLIA测定血清HE4用于辅助诊断卵巢癌，ROC曲线下面积为0.813；CMIA测定血清HE4用于辅助诊断卵巢癌，ROC曲线下面积为0.782。两种检测方法均具有较高的特异性和较好的准确性。 结论 ECLIA和CMIA测定血清HE4结果较为一致，均可作为临床卵巢癌辅助诊断的良好方法。

Objective To investigate the diagnostic value of serum HE4 in patients with ovarian cancer by ECLIA and CMIA. Methods The serum from 39 ovarian cancer patients, 63 benign ovarian diseases patients and 50 healthy individuals were collected. The serum HE4 levels was detected by ECLIA and CMI, and the diagnostic value were evaluated by the two methods. Results The serum level of HE4 was positively correlated between ECLIA and CMIA (r=0.997，P<0.01). There were significant differences in serum HE4 between ovarian cancer patients and ovarian diseases patients or healthy individuals when detected by the same method. When used ovarian diseases patients as control, the area under the ROC curve were 0.813 (ECLIA) and 0.782 (CMIA). Both ECLIA and CMIA had good specificity and accuracy. Conclusion The levels of HE4 detected by ECLIA and CMIA are consistent, and both methods could be used for HE4 detection in the diagnosis of ovarian cancer.