超敏C反应蛋白检测试剂性能验证  

The performance verification of high-sensitive C reactive protein test reagent

作　　者：胡智颖[1] 胡梅[1] 张曼[1] 

机构地区：[1]首都医科大学附属北京世纪坛医院检验科,北京100038

出　　处：《国际检验医学杂志》2014年第17期2313-2314,共2页International Journal of Laboratory Medicine

摘　　要：目的：验证研究试剂与对照试剂检测结果的一致性。方法共收集标本150例，其中血清样本130例，血浆样本20例。以相对差值均值的4倍作为标准化检测界限，剔除5例离群值后重新进行回归分析，计算医学决定水平处预期偏倚以及预期偏倚95％的可信区间，判断医学决定水平处预期偏倚是否在允许范围内。计算研究试剂用于 hs-CRP 用于检测的正确性、重复性。结果研究试剂的正确性验证的回收率在90％～110％，重复性验证的变异系数（CV）小于或等于5．0％，与对照试剂的检测结果相关性良好，同来源采集的血清与血浆样本 hs-CRP 检测值一致，且医学决定水平处预期偏倚在允许范围内。结论研究试剂用于 hs-CRP 检测的准确性、重复性良好，与对照试剂的检测结果有高度一致性。Objective To verify the accuracy,repeatability and consistency with contracting reagent of the high-sensitive C reac-tive protein（hs-CRP）test by using the independently developed reagents.Methods 150 samples were collected,including 130 ser-um samples and 20 plasma samples.4 times of the relative difference of mean value was used as the detection limits,and the regres-sion analysis was performed after excluding 5 sample outliers,then calculated the expected bias at medical decision level with the 95% confidence interval,in order to judge whether the bias was within the allowable range.Results The recovery rate of hs-CRP test reagent were within the allowable range which was 90% -110%.The hs-CRP testing results of plasma and serum samples from the same source were consistent,and the expected bias of medical decision level was in the permissible range.Conclusion The developed reagent used in hs-CRP test have good accuracy,repeatability,and highly consistency with control reagent.

关 键 词：超敏C反应蛋白 对比测试 一致性 

分 类 号：R446.6[医药卫生—诊断学]