促黄体生成激素酶促化学发光免疫分析方法的建立

Chemiluminescence Immunoassay for Luteinizing Hormone

摘要: 采用双抗体夹心一步检测法和鲁米诺过氧化氢发光体系建立了血清促黄体生成激素（LH）的酶促化学发光免疫分析方法。结果显示，本方法测量范围为1.5～200 IU/L，灵敏度为0.08 IU/L，批内变异系数＜9%，批间变异系数＜11%，回收率为96.3%～112.1%，稀释实验测定值与稀释度呈线性相关，相关系数 r =0.995。与进口酶促化学发光免疫分析试剂盒测定的临床值进行比较，线性相关方程为 y =0.967x+ 0.068 9 ，相关系数 r =0.975，相关性良好。方法学鉴定结果符合免疫分析的基本要求。

Abstract: The chemiluminescence immunoassay(CLIA) for serum luteinizing hormone was established by using the reaction of luminol with hydrogen peroxide. The measurement range of this method was 1.5 to 200 IU/L, the sensitivity was 0.08 IU/L, the recovery rate was 96.3% to 112.1%, the coefficient correlation of dilution was 0.995, and the intra- and inter-assay coefficient of variability were 4.09%-8.36% and 5.14%-10.23%, respectively. Compared with Beckman CLIA system, the coefficient correlation was 0.975.