摘要
目的探讨临床检验实验室中不同检验方法之间科学的方法学评价方法。方法本文以低密度脂蛋白胆固醇(LDL-C)检测试剂盒为例,选择了瑞士罗氏(Roche)、日本奥林巴斯(Olympus)与北京利德曼(Leadman)3个厂家的试剂盒进行方法学比对,分别以Roche LDL-C、Olympus LDL-C与Leadman LDL-C同时检测125例正、异常患者血清,通过EP evaluator软件中的Method Comparison模块对检测结果进行了定性(QMC)及定量(AMC)方法学比对分析。结果Leadman LDL-C试剂与其他两家试剂检测结果较为相符,相关性亦较好。AMC分析表明Leadman与Roche LDL-C的相关性良好,其Deming回归方程为:Y=0.982X+0.0551,相关系数r=0.9949(r>0.975);与Olympus LDL-C的相关性较好,Deming回归方程为:Y=1.070X-0.209,相关系数r=0.976。QMC分析表明Leadman与Roche LDL-C的相符程度较好,符合度为83.2%,Cohen's Kappa=85.8%(>75%);Leadman与Olympus LDL-C的相符程度良好,符合度为88.3%,Cohen's Kappa=81.3%,二者测值亦较为接近。结论EPevaluator软件是临床检验实验室在引入新方法或者新的检验系统进行方法学评价的有效方法。
Objective To explore an easy and scientific method of comparing different analysis systems in clinical laboratory. Methods Low density cholesterol analysis kit was set as an example. We selected LDL analysis kits from Roche,Olympus and Leadman and compared three analysis kits by EP evaluator software. We tested 125 normal and patient serum by three methods, and then put all the data into the software. The data was analyzed by quantitative method comparison （AMC） and qualitative method comparison （QMC）. Results QMC showed that Leadman had good relevance with both Roche and Olympus. Deming linear regression： Y（leadman）= 0. 982X（Roche）＋ 0. 0551, with the correlation coefficient of 0. 9949 ;Y（leadman）： 1. 070X（Olympus）-0. 209 with the correlation coefficient of 0. 976 ;QMC showed that Leadman had good conformity with both of the other methods. The conformity factor of Leadman and Roche was 83.2%, Cohen＇s Kappa factor of Leadman and Roche was 85.8 %; Conformity factor of Leadman and Olympus was 88.3% and Cohen＇s Kappa factor was 81.3%. Conclusion EP evaluator is a good and efficient protocol for clinical laboratory to evaluate new method or new system.
出处
《检验医学与临床》
CAS
2010年第3期221-223,共3页
Laboratory Medicine and Clinic
