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

Abstract

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. Key words: Human epididymis protein-4; Ovarian neoplasm, antibodies Monoclonal; Immunoradiometric assay