人促甲状腺激素酶联免疫吸附分析试剂盒的研制
Preparation of TSH Kit by an Enzyme-linked Immunosorbent Assay
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摘要: TSH多抗用于固相包被,一株TSH单抗与辣根过氧化物酶偶联制备TSH酶标记物,以四甲基联苯胺(TMB)为底物,采用二步法,建立了TSH酶联免疫吸附分析法(ELISA)。本方法灵敏度为0.06 mIU/L,批内CV≤5.9%(n=8),批间CV≤9.1%(n=7)。回收率为(98.4~101.4)%。77例正常人血清的TSH均值为1.96mIU/L,用本法与IRMA法同时测定23例病人血样,两者相关方程为Y=1.01X—0.47,相关系数r=0.992。本方法具有简便、快速和准确的特点,适于临床检测和科研应用。Abstract: The method for meaturing is established by the two-step, which enzyme-linked im-munosorbent assay (ELISA) using polyclonal antibody for coating, one monoclonal for labeling with horseradish peroxidase. The sensitivity is 0. 06 mIU/L and analytical recovery of TSH is (98. 4 -101. 4)%. The inter- and intra-assay CV are lower than 9. 1% and 5. 9% respectively. The average concentration of TSH in sera from healthy human (77) is 1. 96 mIU /L. The correlation coefficient of results with TSH IRMA is 0. 992. The assay is a rapid, sensitive, simple and precise method. It is suitable for clinical and research application.