人促黄体生成素吖啶酯化学发光免疫分析方法的建立及评价

The Establishment and Evaluation of Acridinium Ester-Chemiluminescence Immunoassay for Luteinizing Hormone

目的建立基于磁微粒-吖啶酯化学发光系统的人促黄体生成素(LH)全自动定量测定方法。方法根据双抗体夹心法原理,选择一株抗-LH单克隆抗体偶联磁微粒,吖啶酯标记另一株抗-LH单克隆抗体,建立LH化学发光免疫分析方法,并优化了反应体系、反应时间等影响因素,使整个系统达到最佳检测性能。结果本检测方法线性范围为0.25~250IU/L,空白检测限0.01IU/L,不同浓度样本的分析内精密度1.1%~4.4%、分析间精密性1.5%~4.2%,与hCG、FSH、TSH均无明显交叉反应,与贝克曼Access全自动化学发光免疫测定系统回归方程为Y=0.989X+0.214,相关系数r=0.988。结论成功建立了人促黄体生成素的吖啶酯全自动化学发光免疫分析方法,各项指标均满足临床检测的要求,具有一定的临床应用价值。

Objective A chemiluminescence quantitative immunoassay for human luteinizing hormone(LH)was established using magnetic particles and acridinium ester system. Methods According to the principle of double antibody sandwich method,one anti-LH was coated with magnetic particles,and another anti-LH was labeled with acridinium ester.The influencing factors such as reaction system and reaction time were optimized to achieve the best detection performance of the whole system. Results The measurement range of this method was 0.25 to 250 IU/L,with the lower limit of detection 0.01 IU/L.The intra-analysis coefficient of variation for different concentrations of samples were 1.1%~4.4%,and the inter-analysis coefficient of variation were 1.5%~4.2%.No cross reactions with hCG,FSH and TSH were observed.Compared with Beckman CLIA system,the coefficient correlation was 0.988. Conclusion The acridinium aster-chemiluminescence of magnetic particles system for detecting LH has been established,which has excellent performance indicators and can be widely used in clinical testing.