人附睾蛋白4单克隆抗体与免放试剂盒的制备及其对卵巢癌诊断的临床价值探讨

目的 制备人附睾蛋白4(HE4)单克隆抗体并研制免放分析试剂盒, 探讨其在卵巢癌临床诊断中的价值。 方法 用重组人HE4免疫小鼠, 通过细胞融合杂交瘤技术制备并筛选可以配对的HE4单抗, 用125I标记其中一株单抗, 研制HE4免放试剂盒, 并评价其检测的灵敏度。通过检测临床血清标本来评价其对卵巢癌诊断的灵敏度和特异度。 结果 筛选出了一对亲和力与特异性高的HE4单抗, 其免放试剂盒检测的灵敏度为3.65 pmol/L, 其对卵巢癌的临床诊断的灵敏度可达90.83%, 特异度为99.17%。 结论 制备的单克隆抗体亲和力高, 研制的免放试剂盒各项指标较好, 可用于卵巢癌的早期临床诊断和疗效观察, 降低卵巢癌患者的病死率。

Preparation of monoclonal antibodies and immunoradiometric assay kit against human epididymis protein 4 and its clinical value in diagnosis of ovarian cancer

Objective To prepare monoclonal antibodies and immunoradiometric assay kit against human epididymis protein 4 (HE4) and study its clinical value in diagnosis of ovarian cancer.Methods BALB/c mice were immunized with recombinant HE4 antigen,2 paired monoclonal antibodies were generated through splenic cell and myeloma cell fusion and screening.The detection antibody was labeled with 125 Iodine and immunoradiometric assay kit for HE4 was developed.The detect sensitivity of the kit was determined,and its clinical sensitivity and specificity in diagnosis of ovarian cancer was evaluated.Results Two paired monoclonal antibodies with high affinity and specialty were generated.The detect sensitivity of this immunoradiometric assay was 3.65 pmol/L,and the clinical sensitivity and specificity in diagnosis of ovarian cancer was 90.83％ and 99.17％ respectively.Conclusions This study was prepared by a high affinity monoclonal antibodies against HE4,and the technical indexes of HE4 immunoradiometric assay kit were rather good.So it could be used in early diagnosis and curative effect observation of ovarian cancer,and reduce its lethality rate.