8项生化指标测量不确定度评估及允许范围的初步研究  

Preliminary study on the measurement uncertainties and permissible ranges of the eight biochemical indexes

作　　者：徐润灏 张洁[1] XU Run-hao;ZHANG Jie(Clinical Laboratory, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200001, China)

机构地区：[1]上海交通大学医学院附属仁济医院检验科,上海200001

出　　处：《上海交通大学学报（医学版）》2016年第12期1777-1783,共7页Journal of Shanghai Jiao tong University:Medical Science

摘　　要：目的·探讨血清钠(Na)、钾(K)、钙(Ca)、磷(Phos)、葡萄糖(Glu)、肌酐(Crea)、尿素氮(BUN)、尿酸(Uric)这8项生化指标的测量不确定度及其允许范围。方法·参照中国合格评定国家认可委员会(CNAS)技术报告《医学实验室-测量不确定度的评定与表达》和Nordtest准则,采用连续累积的室内质控(IQC)以及国家卫计委临床检验中心室间质评数据(EQA)计算实验室内测量复现性和偏倚,作为分量引入测量不确定度;基于检测项目95%CI导出的允许不精密度和偏倚,计算8项指标测量不确定度及其允许范围;并使用质量指标等级模式进行评估。结果·Na、K、Ca、Phos、Glu、Crea、BUN、Uric这8项指标的测量不确定度分别为2.04%、4.43%、4.29%、4.28%、4.44%、7.33%、6.28%、6.25%;允许不确定度分别为2.67%、5.41%、4.32%、5.88%、6.04%、6.97%、7.54%、7.48%。其中K、Phos、Glu、Crea、BUN和Uric达到质量指标等级模式2的要求,Na和Ca测量不确定度达到等级模式3的要求。结论·8项指标中,K、Phos、Glu、Crea、BUN和Uric测量不确定度和允许范围均达到质量指标等级模式2的要求。目前实验室Na和Ca的方法学和操作技术未达到较为严格的质量标准,应与临床医师沟通,了解临床对Na和Ca的决策需求,由临床和实验室共同研究确定合理的检测允许不确定度范围。Objective · To explore the measurement uncertainties and the allowable ranges of the eight biochemical indexes, including serum Na,K, Ca, Phos, Glu, Crea, BUN, and Uric. Methods · Refer to the technical report "Medical Laboratory - Evaluation And Expression of Uncertaintyin Measurement" by China National Accreditation Service for Conformity Assessment (CNAS) and Nordtest guideline, continuous accumulated datafrom internal quality control (IQC) and external quality assessment (EQA) of National Center for Clinical Laboratories (NCCL) were used to calculatethe laboratory measurement reproducibility and offset, which were then introduced as the components of the measurement uncertainty. Based on theallowable imprecision and the allowable bias derived from the 95% CI of the measurement project, the measurement uncertainties and permissible rangesof 8 biochemical indexes were calculated and then further evaluated by the quality index models. Results · The measurement uncertainties of the 8biochemical indexes, i.e. Na, K, Ca, Phos, Glu, Crea, BUN, and Uric, were 2.04%, 4.43%, 4.29%, 4.28%, 4.44%, 7.33%, 6.28%, and 6.25%, respectively.The allowable measurement uncertainties were 2.67%, 5.41%, 4.32%, 5.88%, 6.04%, 6.97%, 7.54%, and 7.48%, respectively. The measurementuncertainties and the permissible ranges of K, Phos, Glu, Crea, BUN, and Uric met the requirements of quality index grade 2 model and Na and Ca metthe requirements of the model 3 of the quality index inder. Conclusion · The measurement uncertainties and permissible ranges of K, Phos, Glu, Crea,BUN, and Uric met the requirements of the model 2 of the quality index grade. Currently the methodology and operational techniques for Na and Ca inour laboratory can't meet the rigorous quality standards. We should communicate with the clinicians to understand their decision needs for Na and Ca.Reasonable measurement uncertainties and allowable ranges should be determined by both the laboratory and clinicians.

关 键 词：测量不确定度 允许不确定度 参考区间 生化指标 

分 类 号：R446.112[医药卫生—诊断学]