临床方法学比对试验验证产品等效性研究.docVIP

精品论文 参考文献 临床方法学比对试验验证产品等效性研究 罗仁 牟文玉（四川省遂宁市蓬溪县人民医院检验科 629100） 【中图分类号】R44 【文献标识码】A【文章编号】1672-5085（2013）13-0400-03 【摘要】 目的 采用新成生物赛盟自免产品抗双链DNA抗体IgG检测试剂盒(酶联免疫吸附法)与A厂家已批准上市的同类产品针对临床样本进行对比试验研究，验证新成生物赛盟自免产品与已上市产品等效。方法 选择B医院2011年9月至2012年2月确诊为系统性红斑狼疮(SLE)患者55例和同期健康体检者59例，用新成生物赛盟自免产品与A厂家产品平行测定，观察其相关性。结果 新成生物赛盟自免测定抗双链DNA抗体结果与A厂家测定结果作线性回归分析，相关系数R2=0.9683，相关性良好,两者无显著性差异(Pgt;0.05)；同时作Kappa系数检验，Kappa系数=0.921，与A厂家试剂有高度一致性。结论 新成生物赛盟自免产品抗双链DNA抗体IgG检测试剂盒(酶联免疫吸附法)与A厂家已批准上市的产品具有等效性，能为临床医生提供可靠准确有价值的诊断指导依据。 【关键词】 赛盟自免 抗双链DNA抗体 系统性红斑狼疮 线性回归 Kappa系数 Comparison experiment of Methodology verify that the product equivalence study Chen Hong,Chen wei.(Sichuan Sinew Bio-technology Co., Ltd，Sichuan 611731) 【Abstract】objective: Comparation the Diagnostic Kit for Anti-dsDNA IgG（ELISA）of Xincheng SIM and a similar marketed product of A manufacturers by testing the clinical samples, to verify the product of Xincheng SIM and A manufacturers have been equivalent.Methods: Our choice in Septemper 2011 to February 2012,which diagnosed with systemic lupus erythematosus (SLE) patients, 55 cases and 59 cases of healthy person. Parallel determination the product of Xincheng SIM and A manufacturers to observe the correlation.Results: Using the linear regression to estimate the determination of Xincheng SIM and A manufacturers.Thedeterminations of anti-dsDNA are good correlation(R2=0.9683).There is not statistically significant (Pgt;0. 05). At the same time,the Kappa coefficient test shows a high consistency between Xincheng SIM and A manufacturers(Kappa coefficient =0.921).Conclusion: The Diagnostic Kit for Anti-dsDNA IgG（ELISA）of Xincheng SIM and a similar marketed product of A manufacturers have been equivalent.Ir can provide clinicians with reliable and accurate diagnosis of a valuable basis for guiding. 【Key words】SIM Anti-dsDNA antibody Systemic Lupus Erythematosus Linear regression Kappa coefficient 抗双链DNA抗体是系统性红斑狼疮(Systemic Lupus Erythematosus 简称SLE)的特异性抗体，其抗体效价与病情相关，因而，SLE患者需定期