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| 急诊检测血液中乙醇浓度的不确定度评估 【摘要】 目的 评定美国强生Vitros 350全自动干式生化分析仪测定血液中乙醇和其它急诊项目浓度的不确定度。方法 依据不确定度评定的指导性文件,对本实验室强生Vitros 350全自动干式生化分析仪开展的急诊项目的测量不确定度进行评估，按测量不确定度评估的过程，分析不确定度分量的来源并分别按A类和B类进行评估，合成标准不确定度，计算扩展不确定度等。结果 不确定度分量来源主要包括：测量的不精密度、校准品的不确定度。其中，不精密度分量按美国临床和实验室标准协会（CLSI）EP5A文件评定，校准品的不确定度分量根据厂家的溯源性报告评定。结论 本研究只评估测量过程的不确定度,与传统用准确度表示的误差相比,更能反映测量的水平,且对检测结果的临床应用有实际指导意义。 【关键词】 乙醇；不确定度；急诊生化检验；Vitros 350 【Abstract】 Objective The evaluation of uncertainty of measurement of alcohol(ALC),glucose(GLU),urea nitrogen(BUN),creatinine(CREA),uric acid(URIC), amylase(AMY),creatine kinase(CK),calcium(CA),potassium(K ),sodium(NA), chlorinum(CL) and carbon dioxide(CO2) in human blood by VITROS 350 dry-type biochemistry analyzer(Johnson，US).Methods Based on the guidelines of the uncertainty in measurement, the measurement uncertainty of our biochemical laboratory test items were assessed. According the evaluating process of measurement uncertainty, the sources of uncertainty were analyzed and divided into the class A and B for calculating, synthesizing the standard uncertainty and calculating the expanded uncertainty. Results The uncertainty mainly originate from measurement imprecision and calibrator uncertainty. The component of imprecision was evaluated based on CLSI EP5A documents and the component of calibrator uncertainty was evaluated based on the manufacturer′s traceability assessment report. Conclusions This study only evaluated the measurement uncertainty during detection process, and the measurement uncertainty was better to reflect the measurement ability and guide the clinical detection.  |
