β-HCG单克隆抗体酶标法对早期妊娠诊断的临床评价  

Clinical Evaluation of the Urinary β—HCG ELISA for Diagnosis of Early Pregnancy — An Analysis of 375 Cases

作　　者：田顗 郑妍[1] 樊明桢 孙虹[1] 孙跃平 

机构地区：[1]昆明医学院附一院妇产科

出　　处：《昆明医学院学报》1992年第1期1-5,共5页Journal of Kunming Medical College

摘　　要：本文报道了采用β—HCG单克隆抗体酶标法(ELISA),对375份疑为早孕的晨尿标本进行测定,并与放免法(RIA)作比较,通过人工流产组织病理检查及临床随访,确定妊娠以评价此两法对诊断早孕及早早孕的可靠性。结果:诊断早孕及早早孕的临床符合率、阳性符合率、阴性符台率ELISA分别为97.42％、97.14％、98.09％。RIA为97、14％、97.13％、96.22％。无论早孕或早早孕,两法上述指标均无显著性差异(P>0.05)。可疑宫外孕7例中,ELISA有6例,而RIA有5例与随访或剖腹探查术相符合。ELISA的敏感性和特异性分别为99,16％,93.63％,RIA为98.74％,93.63％,二者也无显著性差异(P>0.05)。说明ELISA具有与RIA相当的早孕及早早孕诊断符合率,可作为常规尿妊娠试验,且具有操作简便、迅速、价廉及无放射性等优点,尤其宜在基层推广。对异位妊娠的快速诊断较RIA显得实用。The urine β—HCG enzyme linked immunosorbent assay (ELISA) is a new method for early pregnancy diagnosis. We compared ELISA with RIA for the diagnosis of 375 urinary specimens of doubtful gravidism, which was confirmed afterwards by pathological examination and clinical evaluation. The clinical, positive and negative coincidence of ELISA were 97.42%, 97.14%, 98.09% and those of RIA were 97.14%, 97.13%, 96.22%, respectively. The above-mentioned indexes of the two methods had no significant differnce (P>0.05). Among 7 cases of doubtful ectopic pregnancy, there were 6 cases with EILSA and 5 cases with RIA coincident with clinical evaluation and/or laporotomy. The sensibility and specificity of ELISA were 99.16% and 93.64%; those of RIA were 98.34% and 93.63%. There was no significant difference (P > 0.05). We conclude that the urine β—HCG ELISA has the same value as RIA in the early pregnancy diagnosis. It may be used as a routine method, because it is without radiactivity, and simpler, cheaper, more rapid and practical than RIA, especially it is easy to be generalized in the country.

关 键 词：妊娠诊断 Β-HCG 单克隆抗体 

分 类 号：R714.15[医药卫生—妇产科学]