甲状旁腺激素化学发光免疫分析试剂盒的开发及临床应用  

Development and Clinical Application of Chemiluminescence Immunoassay for PTH

作　　者：任峰[1] 韩霜 REN Feng;HAN Shuang(Department of Laboratory Medicine,The Affiliated Hospital of Jiangnan University,Wuxi 214122,Jiangsu,China;Department of Pathology,The Affiliated Hospital of Jiangnan University,Wuxi 214122,Jiangsu,China)

机构地区：[1]江南大学附属医院医学检验科,江苏无锡214122 [2]江南大学附属医院病理科,江苏无锡214122

出　　处：《实验与检验医学》2024年第2期134-138,共5页Experimental and Laboratory Medicine

摘　　要：目的用双抗体夹心法建立人血清甲状旁腺激素的化学发光免疫测定方法。方法反应模式为生物素化的甲状旁腺激素抗体和吖啶酯标记的甲状旁腺抗体和样本中的抗原形成“三明治”复合物,通过加入发光底物读取信号值来计算待测物浓度,并且分析解决钩状效应的方法。结果建立了人血清甲状旁腺激素的双抗体夹心化学发光免疫测定方法,所建立的方法具有良好的分析性能和热稳定性。采用四参数方程建立测定甲状旁腺激素的标准曲线。空白限为0.2 pg/mL,批内精密度为4.07%~7.17%,批间精密度为3.30%~8.91%,回收率为91%~109%。加速稳定性试验显示,试剂在37℃表现出良好的稳定性。当甲状旁腺激素浓度为40000 pg/mL时,未观察到钩状效应。用所建立的方法与贝克曼库尔特UniCel DxI 800免疫分析系统同时测试207份血清样本,进行比对分析,线性回归方程为y=0.986x+0.5594,相关系数(r^(2))为0.9739,结果具有很好的一致性。结论本研究的试剂盒检测结果与临床结果符合较好,试剂盒可以应用于临床辅助诊断。Objective A chemiluminescent immunoassay for human serum PTH was established using a double-antibody sandwich model.Methods The reaction mode was that the biotinylated PTH antibody and acridine ester labeled PTH antibody formed a"sandwich"complex with the antigen in the sample.By adding the luminescent substrate to read the signal value to calculate the concentration of the object to be measured.Results The established method showed good analytical performance and thermal stability.The limit of detection was 0.2 pg/mL.The intra-assay coefficient of variation(CV)was 4.07%~7.17%,the inter-assay CV was 3.30%~8.91%,and the recovery rate was 91%~109%.An accelerated stability study revealed that the developed reagent showed great stability under 37℃.When the PTH concentration was 40000 pg/mL,no hook effect was observed.207 serum samples were tested,and the results were compared to Beckman's test data.The linear regression equation was y=0.986x+0.5594,The correlation coefficient is 0.9739.The developed method showed good correlation with Beckman's test data.Conclusion The results of the kit in this study are in good agreement with the clinical results,and the kit can be used in clinical diagnosis.

关 键 词：甲状旁腺激素 化学发光 吖啶酯 钩状效应 双抗体夹心法 

分 类 号：R582[医药卫生—内分泌]