论文部分内容阅读
目的:研制人血清中促甲状腺素(TSH)的化学发光免疫检测试剂盒。方法:采用辣根过氧化物酶标记的抗TSHβ亚单位特异性单克隆抗体(mAb),与固相包被的抗TSHα亚单位的另一mAb配对,以鲁米诺作为底物,采用两步法建立了双位点夹心法人血清TSH的化学发光免疫定量分析法。结果:该方法灵敏度为0.0788mIU/L,批内CV平均为4.7%,批间CV平均为8.4%,平均回收率为93.05%。该检测与LH、FSH和HCG无交叉反应。部分实验样品的测试结果显示该试剂与国外同类试剂(雅培architect i2000)的测定结果明显相关(r=0.984)。结论:该方法具有较高的灵敏度、重复性和准确度,与其他同类产品相比简便、快捷、成本低,适于临床检测和科研应用。
Objective: To develop a chemiluminescence immunoassay kit for thyrotropin (TSH) in human serum. METHODS: Horseradish peroxidase-conjugated anti-TSHβ subunit-specific monoclonal antibody (mAb) was used to pair with another mAb coated with anti-TSHα subunit of solid phase. Luminol was used as a substrate and two A step-by-step method was established for the chemiluminescence immunoassay of double-site sandwich-type human serum TSH. Results: The sensitivity of the method was 0.0788mIU / L, the average CV within the batch was 4.7%, the average CV between batches was 8.4%, and the average recovery was 93.05%. The test and LH, FSH and HCG no cross-reaction. The test results of some of the experimental samples show that this reagent is obviously related to the assay results of the same foreign reagent (Abbott architect i2000) (r = 0.984). Conclusion: The method has high sensitivity, repeatability and accuracy, compared with other similar products is simple, fast, low cost, suitable for clinical testing and research applications.