TSH双位点单抗免疫放射测定法的建立及临床应用  

ESTABLISHMENT AND PRELIMINARY CLINICAL APPLICATION OF TWO-DIFFERENT-EPITPOES-MONOCLONAL-ANTIBODY IMMUNORADIOMETRIC ASSAY FOR THYROTROPIN

作　　者：罗敏[1] 姬秋和 陈淑菁 曹文俊[1] 赵萸[1] 谢晓雁[1] 陈家伦[1] 

机构地区：[1]上海第二医科大学附属瑞金医院,上海市内分泌研究所

出　　处：《中华内分泌代谢杂志》1995年第3期165-166,162,共3页Chinese Journal of Endocrinology and Metabolism

基　　金：上海市卫生局科技发展基金

摘　　要：采用本所制备及鉴定的二株不同位点的抗ｈ－ＴＳＨ单抗１３Ｂ４和８Ｅ７，建立了高灵敏度、高特异的ｈ－ＴＳＨ免放测定法。其中经饱和硫酸铵和ＰｒｏｔｅｉｎＡＳｅｐｈａｒｏｓｅ亲和层析柱纯化的１３Ｂ４以Ｉｏｄｏｇｅｎ固相法进行碘标，纯化的８Ｅ７（１∶１００稀释度）作塑料管固相抗体。方法学鉴定表明，本法与生理剂量的其他糖蛋白激素ｈ－ＦＳＨ、ｈ－ＬＨ、ｈＣＧ无明显交叉反应，灵敏度达０．０２６ｍＵ／Ｌ（－ｘ±２ｓ），批内ｃｖ为１．２３～７．３０％，批间ｃｖ为１２．３％。稀释度试验示平行线性关系好，ｒ＝０．９９９。初步临床应用结果表明：甲亢６４例，ＴＳＨ值为未测得（ＮＤ）～０．３１ｍＵ／Ｌ，９５％可信限为ＮＤ～０．２６３ｍＵ／Ｌ；甲减２８例，ＴＳＨ范围为６．６～１８２ｍＵ／Ｌ；甲状腺功能正常者９８例ＴＳＨ为１．４５ｍＵ／Ｌ（Ｐ＿（５０）），９５％可信限为０．３２６～６．０５９ｍＵ／Ｌ。本法与瑞士Ｓｅｒｏｎｏ酶免药盒同时测定１２８例，两种结果的相关系数ｒ＝０．８４４（Ｐ＜０．０１）。经上海华山医院等４家医院初步临床试用，结果表明本法与国内外同类型药盒相比，测定方法简便，相关性高，临床符合率好。A sensitive,specific immunoradiometric assay for human thyrotropin has been established with two monoclonal antibodies.The two monoclonal antibodies have different epitopes,one of them has been labeled with I￣(25) and another is coated on polyethylenetubes.This assay can detect hTSH at a concentration of 0.026 mU/L,and has no cross-reactions with hLH, hFSH and hCG,whilethe parallelism test shows good results.The intra-CVs range from1.23% to 7.30%,and inter-CV is 12.3%. Preliminary clinicalapplication showed that:the TSH concentration in 64 patients with hyperthyroidism was ND～0.263 mU/L,that in 28 cases withhypothyroidism 6.6～182.0mU/L and that in 98 euthyroid cases 1.45 mU/L(P_(50)),95% confidence interval is 0.326～6.059 mU/L.The results measured with the present method showed a good relationship with the immunoenzymeassay kit of Serono Company.Four hospitals in Shanghai had tested our kits,their results were satisfactory.

关 键 词：促甲状腺素 双位点 免疫放射法 单克隆抗体 

分 类 号：R446.61[医药卫生—诊断学]