国产总胆固醇试剂的临床应用研究  

Clinical Application Study on Domestic Total Cholesterol Reagent

作　　者：张学平[1] 王云霞[2] 张萍[1] 

机构地区：[1]克拉玛依市中心医院检验科,新疆克拉玛依834000 [2]乌鲁木齐市疾病预防控制中心艾滋病科,乌鲁木齐830026

出　　处：《现代检验医学杂志》2010年第6期90-91,93,共3页Journal of Modern Laboratory Medicine

摘　　要：目的 评价并用总胆固醇国产试剂替代进口试剂,进口试剂为美国贝克曼公司生产,国产试剂由新疆卡纳思生物技术有限公司生产.方法 采用全自动生化分析仪对国产总胆固醇试剂（TCK）进行临床化学检验的方法学评价.结果 TCK的批内、批间CV分别为1.82%和2.11%,小于1/3 CLIA＇88规定的可接受性能值（3.33%）;TCK与进口试剂有良好的相关关系（r=0.995 5）,在决定性浓度水平上估计的系统偏差为1.05%（0.06 mmol/L）,小于1/2 CLIA＇88规定的最大允许误差（5.00%）.结论 国产TCK稳定、可靠,完全可以在Beckman Coulter DXC800型全自动生化分析仪上替代进口TC试剂.Objective To evaluate the domestic total cholesterol（TCK） reagent according to the CLIA＇ 88 in order to replace imported total cholesterol（TC） reagents. Methods TCK reagent kit was used to assay TCK in serum and its precision ,linearity range ,the inter and intra imprecision（CV）,and correlation were analysed in automatic biochemical analyzer. Results The inter and intra CV of TCK were 1.82% and 2.11% respectively and the system bias was 1.05%. There was a good relationship （r= 0. 995 5） between TC and TCK,respectively. Conclusion Domestic reagent TCK is stable,reliable,it could be used fully in Beckman Coulter DXC800 automatic biochemical analyzer.

关 键 词：总胆固醇 国产试剂 评价 

分 类 号：R446[医药卫生—诊断学]