不同厂家血脂试剂的分析性能验证  

Validation of Lipids Reagents of Different Manufactures

作　　者：韩建华[1] 任凤琴[1] 苏薇[1] 邱玲[1] 

机构地区：[1]中国医学科学院北京协和医学院北京协和医院检验科,北京100730

出　　处：《现代检验医学杂志》2010年第3期84-87,共4页Journal of Modern Laboratory Medicine

摘　　要：目的验证不同厂家血脂试剂的各项性能参数。方法用六个厂家的血脂试剂，采用NCCLSEP6-A，EP15-A，EP5-A等文件提供的方案对方法的灵敏度、线性范围、不精密度、可疑干扰物质等进行验证。结果不同厂家血脂试剂的灵敏度均低于厂家提供的数据；线性范围均落在各厂家提供的线性范围之内，准确度满足该实验室要求；不同厂家的血脂试荆不精密度有差异，德赛公司和日本积水医疗株式会社的不精密度较好，而有的试剂由于批间差异大导致总变异系数较大；不能证明高TG浓度对LDL—C检测产生的影响是由于试剂原因引起的；不同厂家血脂试剂抗干扰能力不尽相同，高TBIL时对各种血脂试剂的检测都存在干扰，而对其它临床可疑干扰则可以通过选择适当的血脂试荆加以避免。结论经过验证认为，不同厂家的血脂试剂在血脂检测中各项性能略有不同，应选择适合各自实验室的脂类试剂使用。Objective To validate different lipids reagents. Methods Validating lipids reagents of six manufactures in sensitivity, linearity, imprecision, questionable disturbance according to NCCLS EP6-A, EP15-A and EP5-A. Results The sensitivitys of all reagents were lower than manufacture＇ s. The linearity of all reagents within manufacture＇s and the accu- racy was satisfied with our standand. The imprecision of different manufacture＇s reagents was different, the imprecision was better between Diasys Diagnostic Systems and SEKISUI CHEMICAL and some reagents had great CV % tatal because of great CV% betweenin. Couldn＇t prove that reagent was the most reason of LDL-C differences when TG was higher. The anti- disturbance ability of different manufacture＇s reagents was different ,high TBIL had more serious effects and could avoid it through different reagents. Conclusion The validation of different lipids reagents is different and the laboratory should select suitable lipids reagents.

关 键 词：血脂试剂 不同厂家 性能验证 

分 类 号：R446.112[医药卫生—诊断学]