摘要
目的 研制人血清中促黄体生成素 (LH)的化学发光免疫检测试剂盒。方法 以LH单克隆抗体作为固相包被 ,LH多克隆抗体与碱性磷酸酶偶联制备酶标抗体 ,以金刚烷胺作为底物 ,采用两步法建立了双位点夹心法人血清LH的化学发光免疫定量分析法。结果 该方法的敏感度为 1mIU/ml,可测范围为 1～ 2 0 0mIU/ml,批内和批间的变异率分别为 6.7%和 7.7% ,回收率在 85 %～1 1 0 %之间。本法与TSH的交叉为 1 .3 % ,与FSH的交叉为0 .0 2 % ,与HCG的交叉为 0 .0 8% ,血清样品测定结果与国外同类试剂的测定结果呈正相关 ,相关系数r=0 .993。结论 该试剂盒有较高的灵敏度 ,重复性和准确度 ,与国外同类试剂有良好的相关性 ,适合用于临床检验。
Objective To develop a chemiluminesent immunoassay(CLIA) test kit for quantitative determination of luteinizing hormone (LH) in human serum. Methods The two-site assay was based on the direct sandwich technique. A monoclonal antibody was employed for coating, another polyclonal antibody for labeling with alkaline phosphatase. CSPD and Sapphire II was used for substrate system. Results The minimum detectable dose was 1m IU/ml. The linear response was from 1 to 200 mIU/ml.The between-runs CVs and the within-runs CVs were 7.7% and 6.7% respectively. The analytical recovery was 85% to 110%. The cross-reacting rate with TSH was 1.3%,and that with FSH and HCG was 0.02% and 0.08% respectively. Compared with the imported CLIA kit, the correlation coefficient was 0.993. Conclusion The kit has better sensitivity,reproducibility and accuracy.It has a good relativity as the imported CLIA test kit. It is suitable for clinical application.
出处
《河南科技大学学报（医学版）》
2004年第2期83-84,共2页
Journal of Henan University of Science & Technology:Medical Science
