血常规项目测量不确定度评定

Evaluation on measurement uncertainty of blood routine examination

目的评定血常规项目的测量不确定度,探讨室内质量控制(IQC)数据结合参加希森美康网络通讯系统(SNCS)的比对数据进行不确定评定方法的可行性。方法参照CNAS-TRL-001文件,对白细胞(WBC)计数、红细胞(RBC)计数、血红蛋白(Hb)测定、红细胞比积(HCT)、血小板计数(PLT)等5个血常规项目,采用IQC数据评定实验室内测量复现性引入的测量不确定度分量,分别采用能力验证(PT)数据和SNCS数据评定偏移(bias)引入的标准不确定度,计算相对合成标准不确度及相对扩展不确定度,并比较PT数据和SNCS数据所得出的评定结果。结果各项目利用IQC数据结合PT数据评定的相对扩展不确定度,从水平1到水平3依次为:WBC(10.02%、7.24%、7.04%);RBC(2.40%、1.72%、1.92%);Hb(3.54%、2.56%、2.50%);HCT(4.12%、3.18%、2.86%);PLT(15.36%、8.86%、7.94%)。各项目利用IQC数据结合SNCS比对数据评定的相对扩展不确定度,从水平1到水平3依次为WBC(11.66%、7.34%、6.40%);RBC(2.26%、1.60%、1.64%);Hb(3.36%、2.36%、2.10%);HCT(3.36%、3.04%、3.18%);PLT(13.34%、8.36%、7.14%)。结论血常规项目结果的测量不确定度符合其目标不确定度的要求,可以采用IQC数据结合SNCS数据进行血常规项目测量不确定度的评定。

Objective To explore the feasibility of measurement uncertainty in complete blood count using internal quality con-trol(IQC) data associated with Sysmex Network Communication System(SNCS) comparative data .Methods Complete blood count assay including white blood cell(WBC) count ,red blood cell(RBC) count ,hemoglobin(Hb) determination ,hematocrit(HCT) values and platelet(PLT) count were involved to evaluate measurement uncertainty according to the instruction of CNAS-TRL-001 .Meas-urement uncertainty evaluation was established by internal measurement reproducibility using IQC data ,and standard measurement uncertainty by bias using proficiency testing(PT) data and SNCS data ,followed by relative combined standard measurement uncer-tainty and relative expanded measurement uncertainty was calculated .Meanwhile ,the measurement uncertainty was compared by u-sing PT data and SNAS comparative data .Results Relative expanded measurement uncertainty of the above mentioned index by u-sing IQC data associated with PT data was the following :WBC(10 .02% ,7 .24% ,7 .04% ,from level 1 to level 3 respectively) ,RBC (2 .40% ,1 .72% ,1 .92% ,from level 1 to level 3 respectively) ,Hb(3 .54% ,2 .56% ,2 .50% ,from level 1 to level 3 respectively) , HCT(4 .12% ,3 .18% ,2 .86% ,from level 1 to level 3 respectively) ,PLT(15 .36% ,8 .86% ,7 .94% ,from level 1 to level 3 respec-tively) .Relative expanded measurement uncertainty of the above mentioned index by using IQC data associated with SNCS compar-ative data was the following :WBC(11 .66% ,7 .34% ,6 .40% ,from level 1 to level 3 respectively) ,RBC(2 .26% ,1 .60% ,1 .64%from level 1 to level 3 respectively) ,Hb(3 .36% ,2 .36% ,2 .10% ,from level 1 to level 3 respectively) ,HCT (3 .36% ,3 .04% , 3 .18% ,from level 1 to level 3 respectively) ,PLT (13 .34% ,8 .36% ,7 .14% ,from level 1 to level 3 respectively) .Conclusion Measurement uncertainty in complete blood cell could be estimated by using IQC data associated with SNCS comparative data , which is in accord with the instrument of target measurement uncertainty .