实验室内不同检测系统比对周期及比对方案探讨

The investigation of different antitheses tests in different detecting systems

目的按ISO15189要求对两台生化分析仪上相同检测项目进行方法比较和偏倚评估,以评估检测结果的一致性。方法参照美国国家临床实验标准委员会(NCCLS)EP9-A2文件建立标准比对方案及每月用10份新鲜混合血清进行比对的常规比对方案,将比对结果进行线性回归分析,评估各项目偏倚是否在可接受范围内。结果两台生化分析仪上12个被评价项目经两种比对方案比对结果均满足质量目标要求。结论按EP9-A2文件进行规范化的比对是基础,常规比对能扩大监控范围,及时发现分析中的不稳定因素,两种比对方案结合使用能更好地控制实验室内结果的一致性。

Objective To estimate the consistency of two biochemistry analyzers according to the requirement of ISO15189.Methods both the routine and standard antitheses test form NCCLS EP9-A2 document were underwent.The results were subject to linear-regression analysis and the bias of 12 biochemical items in the above two tests were estimated.Results The results of 12 biochemical items satisfied the requirement of quality target by the two different tests.Conclusion Based on the standard antitheses test form NCCLS EP9-A2 document,the routin antitheses test is capable to expand the monitoring range and find the unstable factors in the analysis in time.Moreover,the combination of these two tests is better for us to control the consistency of clinical results.