促黄体生成素定量测定试剂盒(化学发光免疫分析法)的临床性能评价  

Clinical research of luteinizing hormone(LH) quantitative diagnostic kit by chemiluminescent immunoassay(CLIA)

作　　者：周颖[1] 方婉仙 吴英松[3] 

机构地区：[1]广州市疾病预防控制中心,广东广州510440 [2]广州市达瑞生物技术股份有限公司,广东广州510663 [3]南方医科大学,广东广州510515

出　　处：《分子诊断与治疗杂志》2017年第1期41-45,共5页Journal of Molecular Diagnostics and Therapy

基　　金：国家高技术研究发展计划(863计划)(2011AA02A101)

摘　　要：目的对广州市达瑞生物技术股份有限公司的促黄体生成素定量测定试剂盒(化学发光免疫分析法)进行临床应用研究及临床性能评价。方法采用平行、盲法、对照试验设计,用达瑞生物公司试剂盒检测335例样本,以雅培公司的促黄体生成素测定试剂盒(化学发光微粒子免疫检测法)作为对照试剂盒,罗氏公司的促黄体生成素检测试剂盒(电化学发光法)作为复核试剂盒。操作按各试剂盒说明书进行,对达瑞生物公司试剂盒的符合率和相关性进行计算分析。结果同雅培公司试剂盒比较,达瑞生物公司试剂盒检测血清样品异常符合率为95.8%,正常符合率为95.2%,总符合率为95.4%,Kappa值为0.898(P<0.01)。线性回归方程为Y=0.358+0.961X,两者测定值接近,相关系数为0.988(P<0.01),相关性良好。同血清检测结果相比,血浆检测结果 Kappa值为1.000(P<0.01),线性回归方程为Y=0.120+0.966X,相关系数r值为0.999(P<0.01),相关性良好。特异性样本检测结果均为正常。结论本试剂盒检测性能可以满足临床应用的需要。Objective To investigate the clinical value of the new Luteinizing Hormone Quantitative Diagnostic Kit by Chemiluminescent Immunoassay（LH-CLIA kit） produced by Darui Biotechnology Co., Ltd.for detection of LH by CLIA. Methods In a double blind controlled trial, the Darui LH- CLIA kit was compared against the Abbot LH-CLIA kit by measuring the LH levels of 335 serum samples. With LH-CLIA kit produced by Abbott（Chemiluminescence particles immunoassays） as a control, and with LH-CLIA kit produced by Roche（electrochemical luminescence method） as an inspection test. According to the kit instructions to operate, to calculate and analysis the coincidence rate and correlation of LH- CLIA kit produced by Darui Biotechnology Co., Ltd. Results Compared with the Abbott LH-CMIA kit, the abnormal coincidence rate was 95.8%, and the normal coincidence rate was 95.2%, the total coincidence rate was 95.4%, the Kappa value was 0.898（P〈0.01）. The analysis of quantitative determination indicated that measured serum sample value by Darui LH-CLIA kit is close to Abbott LH-CMIA kit. The linear regression equation was Y=0.358＋0.961 X, the correlation coefficient was 0.988（P〈0.01）, which showed good correlation. Compared with the serums, the Kappa value of the plasmas was 1.000（P〈0.01）, the correlation coefficient was 0.999（P〈0.01）, the linearregression equation was Y=0.120 ＋ 0.966 X. The specificity samples test result was normal. Conclusion Darui LH-CLIA Kit is a valuable diagnostic kit for clinic application.

关 键 词：促黄体生成素(LH) 化学发光免疫分析法(CLIA) 试剂盒 

分 类 号：R446.6[医药卫生—诊断学]