摘要
目的对丙肝病毒抗体测定的方法学性能进行评价和分析。方法取卫生部临床检验中心指定生产的丙肝病毒抗体的弱阳性质控血清,对给定的临界值浓度进行+20%、-20%的配制并检测,建立自己实验室的该项目临界值浓度;连续20d对丙肝抗体弱阳性质控血清检测,计算s/co值,统计分析日间不精密度CV;用EQA的质控物检测丙肝抗体,进行阴、阳性符合率计算。结果丙肝病毒抗体定性试验的临界值为:1NCU/ml;阴、阳性符合率为100%;日间不精密度CV是11.46%。结论丙肝病毒抗体测定的定性试验检测方法的分析性能能满足要求,评价方案简单易行,项目临界值水平与厂家提供的相同,说明厂家提供的方法学指标必须经过验证,各实验室应建立自己的丙肝病毒抗体方法学性能指标。
Objective To appraise and analysis for experimental verification in methods of blood serum marks in qualitative test at anti-HCV. Methods Used weak positive blood serum of controled at HCV blood serum marks by NCCL appointed. Carry out make up ＋20% ,-20% critical concentration in assigned item,Carry out test, establish our critical concentration, test weak positive blood serum of eontroled at HCV blood serum continual 20 d, calculate s/co, CV. Used blood serum of controled of anti-HCV at EQA by NCCL, Test anti-HCV, calculate accorded rate of positive and negtive. Results Critical concentration at HCV blood serum in our labo- ratory were： critical concentration： 1 NCU/ml. It was 100% that accorded rate of positive and negtive of HCV blood serum marks. CV of precision daily： ≤ 11.46%. Conclusion It satisfied demand that experimental verification in methods of blood serum marks in qualitative test at HCV, Its Appraision was simple and easy, It was same that critical concentration in assigned item between our Laboratory and manufacturer gived. It must verification methods indexes manufacturer gived directly. It must establish its critical concentration in experimental verification in methods indexes of blood serum marks in qualitative test at anti-HCV at every Laboratory.
出处
《中国实用医药》
2009年第32期15-16,共2页
China Practical Medicine
