8项生化指标测量不确定度评估及允许范围的初步研究

发布时间：2018-06-08 05:29

本文选题：测量不确定度 + 允许不确定度　；参考：《上海交通大学学报(医学版)》2016年12期

【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。
[Abstract]:Objective to investigate the uncertainty and the allowable range of measurement of serum Na +, K (K), Ca (C), P (hosn), glucose (Glua), creatinine (Cr), bun (bun) and uranate (Urica). Methods according to the technical report "Medical Laboratory-Evaluation and expression of uncertainty of Measurement" and Nordtest criterion of China National Accreditation Committee for conformity Assessment (CNASA), The indoor quality control (IQC) and EQA were used to calculate the repeatability and bias in the laboratory, and the uncertainty of measurement was introduced as the component. Based on the allowable inaccuracy and bias derived from the test item 95CI, the measurement uncertainty and the allowable range of the eight indexes are calculated and evaluated using the quality index grade model. Results the uncertainty in the measurement of the eight indexes, Nahkko CaPhosGlu-Crea BUNUric, was 2.04444.43U and 7.284.287.336.280.The uncertainty of the eight indexes was 2.675.41and 4.325.886.047.977.547.488.Results the uncertainty was 2.675.41and 4.322.886.046.976.976.977.480.Results the uncertainty was 2.675.41and 4.322.886.046.970.Results the uncertainty of the eight indexes was 2.044, 4.433.29 and 4.297.28, respectively. Among them, KPhosn GluA bun and Uric meet the requirement of grade 2 of quality index. The uncertainty of Na and Ca measurement meets the requirement of Grade 3. Conclusion the uncertainty and allowable range of the measurement of KPhosGlun Creabun and Uric all meet the requirements of model 2 of the quality index. At present, the methods and operating techniques of Na and Ca in laboratory are not up to the strict quality standard, so we should communicate with clinicians to understand the decision-making needs of Na and Ca in clinic. A reasonable range of allowable uncertainty for detection is determined by clinical and laboratory studies.
【作者单位】：上海交通大学医学院附属仁济医院检验科;
【分类号】：R446.112

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