CAJ | 학술논문

采用双抗体夹心法建立了定量检测人血清中促甲状腺激素含量的酶促化学发光免疫分析方法，其中，1株抗TSH抗体包被96孔微孔板，另1株与辣根过氧化物酶结合形成酶标记物，鲁米诺-过氧化氢作为发光底物。该方法测量范围为0.1～100 mIU/L ，分析灵敏度为0.04 mIU/L ，批内、批间变异系数分别为3.98％～6.48％和4.61％～13.1％，回收率为95.8％～117.4％，高浓度 TSH样品系列倍比稀释后，测定值与稀释度呈线性相关，相关系数大于0.99。与LH的交叉率＜1.62％，与FSH和 HCG的交叉率分别＜0.05％和＜0.02％。与罗氏化学发光免疫分析方法测定的临床值进行比较，相关性方程为 y＝1.10 x -0.207，相关系数 r＝0.969。与免疫放射分析试剂盒进行比较，相关性方程为 y＝1.00 x＋0.191，相关系数 r＝0.965。本方法操作简便、快速，适用于临床检测和科研应用。
채용쌍항체협심법건립료정량검측인혈청중촉갑상선격소함량적매촉화학발광면역분석방법，기중，1주항TSH항체포피96공미공판，령1주여랄근과양화물매결합형성매표기물，로미낙-과양화경작위발광저물。해방법측량범위위0.1～100 mIU/L ，분석령민도위0.04 mIU/L ，비내、비간변이계수분별위3.98％～6.48％화4.61％～13.1％，회수솔위95.8％～117.4％，고농도 TSH양품계렬배비희석후，측정치여희석도정선성상관，상관계수대우0.99。여LH적교차솔＜1.62％，여FSH화 HCG적교차솔분별＜0.05％화＜0.02％。여라씨화학발광면역분석방법측정적림상치진행비교，상관성방정위 y＝1.10 x -0.207，상관계수 r＝0.969。여면역방사분석시제합진행비교，상관성방정위 y＝1.00 x＋0.191，상관계수 r＝0.965。본방법조작간편、쾌속，괄용우림상검측화과연응용。
The chemiluminescence immunoassay for thyroid stimulating hormone in human serum was developed . Two monoclonal antibodies of TSH were used in the assay ,one of which was labeled with horseradish peroxidase (HRP) and the other was coated on the microtiter plate .Luminol was used as the substrate of HRP and hydrogen peroxide was introduced into this system . The standard range of the method is 0.1-100 mIU/L . The assay sensitivity is 0.04 mIU/L . The intra- and inter-assay coeffi-cients of variance are 3.98%-6.48% and 4.61%-13.1% .Analytical recovery is 95.8%-117.4% .The correlation coefficient between measured and expected values is more than 0.99 .The cross reaction rate with LH is less than 1.62% ,and that with FSH and HCG is less than 0.05% and 0.02% ,respectively .Compared with determine value clinically in chemiluminescence immunoassay (CLIA ) kit from Roche company ,the correlative equation is y = 1.10 x -0.207 , and correlation coefficient is 0.969 . Compared with immunoradiometric assay (IRMA ) kit ,the correlative equation is y= 1.00 x+ 0.191 , and correlation coefficient is 0.965 . This method is rapid and convenient , and it is suitable for clinical and research application .