单抗早孕胶乳凝集抑制试验试剂的研制及初步应用

Preparation and Preliminary Application of the Latex Agglutination Inhibition Test with Monoclonal Antibody of hCG for Early Preg-nancy Detection.

通过细胞融合技术筛选了一株抗HCG的单克隆抗体1F_7。其小鼠腹水效价为10000(胶乳凝集法),免疫球蛋白分类为IgGl,亲和性为2.2×108M^(-1),其主要针对β-HCG上的某一决定簇。用该单抗和高效价的HCG致敏的羧化聚苯乙烯胶乳制成了单抗旱孕胶乳凝集抑制试验的试剂盒。该试剂盒的敏感度为0.63IU/ml左右,和促黄体激素(LH)、促滤泡激素(FSH)无交叉反应,该试剂的稳定性相当好,在室温避光处可保存一年。通过临床355例标本考核,其阳性率为99.2％,其阴性率为100％。

The monoclonal antibody IF7 against human chorionic gonadotropin ( hCG ) was abtained by fusion of the spleen cells with myeloma. The liters from mouse ascitic fluid were found to be 10 000(latex agglutination method). The McAb were identified as mouse IgGl. The affinity constants for the McAb were 2. 2× 108M-1. The McAb could primarily recognize hCG -β subunit. The latex agglutination inhibition test with monoclonal antibody of hCG for early pregnancydetection was prepared by employing the McAb and carboxyl polystyrene latex coated by hCG. The reagent sensitivity was about 0. 63 iu/ml. there was no cross reaction with hLH and hFSH. At room temperature, its stability was tested to be one year. In a clinical preliminary testing of 255 samples of pregnancy urine .the positiv results are 99. 2%;In 100 samples of nonpregnancy urine the negative results are 100%.