14项临床化学检验指标分析前不确定度评定  

Estimation of pre-analytical measurement uncertainty for 14 serum analytes in clinical chemistry

作　　者：李娴[1] 季伙燕[1,2] 苏建友[1] 景蓉蓉[1] 沈荣春[1] 王惠民[1,2] 

机构地区：[1]南通大学附属医院检验科,江苏南通226001 [2]南通大学检验医学研究所,江苏南通226001

出　　处：《临床检验杂志》2014年第6期460-462,共3页Chinese Journal of Clinical Laboratory Science

基　　金：南通市科技项目(HS2012009);国家质检总局公益性行业科研专项经费项目(201210066)

摘　　要：目的以14项临床生化指标为例,探讨评定分析前不确定度的方法。方法招募25名志愿者,各采集左右手臂共7管血,按照设定的参照方法及常规检验所用方法处理标本血清,于同一批内将结果配对计算分析。结果 LDH对每个因素都最敏感,分析前相对不确定度为12.01%;其次为AST、Glu,大于6.00%;Urea、TC分别为1.05%、1.61%;ALT、ALP、GGT、Cr、UA、TG、HDL-C、LDL-C、CK为2.5%~5.0%。AST、ALP、Urea、Cr、TC、TG因采血手臂不同带来的不确定度大;ALT、LDH、GGT、Glu由凝血时间不同带来的不确定度较大;LDL-C受运输方式的影响较大;UA、HDL-C、CK受真空管类型不同影响较大。结论通过计算各分析前不确定度,说明采取相应对策从源头上减小不确定度值的必要性;其计算方式有望应用于其他指标与因素。Objective To probe into the methods of evaluating the pre-analytieal uncertainty based on 14 clinical biochemical tests. Methods Twenty-five volunteers were recruited and 7 blood samples were collected from left or right arm of each individual. The blood samples were disposed according to the given reference method or the routine method that was applied in clinical laboratories with some deviations from the reference method. Fourteen clinical biochemical analytes in the serum samples were measured in the same batch and the results were matched and calculated. Results Among the measured 14 analytes, LDH was the most sensitive for each influencing factors and the pre-analytical relative combined uncertainty was 12.01% , followed by AST and glucose, both of which presented more than 6.00% of pre-analytical relative combined uncertainty. The pre-analytical relative combined uncertainty of ALT, ALP, GGT, creatinine, uric acid, triglyceride, HDL-C, LDL-C and creatine kinase were between 2.5% and 5%, and those of urea and total cholesterol were 1.05% and 1.61% respectively. For AST, ALP, urea, creatinine, total cholesterol and triglyceride, the uncertainty caused by the different arm was more than the other factors, and for ALT, LDH, GGT, glucose, the uncertainty caused by dotting time was more significant. The uncertainty of LDL-C was more affected by the transport modes, while that of uric acid, HDL-C and creatine kinase was more affected by the type of vacuum tube. Conclusion The calculation of the pre-analytical uncertainty could indicate the sources of uncertainty, therefore the corresponding countermeasures may be adopted to reduce the uncertainty. This calculation mode should be available in the evaluation of other influencing factors.

关 键 词：测量不确定度 分析前 生化检验 

分 类 号：R446[医药卫生—诊断学]