Milinković Neda, Ignjatović Svetlana, Šumarac Zorica, Majkić-Singh Nada
Center for Medical Biochemistry, Clinical Center of Serbia, Belgrade, Serbia.
Department for Medical Biochemistry, University of Belgrade, School of Pharmacy, Belgrade, Serbia.
J Med Biochem. 2018 Jul 1;37(3):279-288. doi: 10.2478/jomb-2018-0002. eCollection 2018 Jul.
An adequate assessment of the measurement uncertainty in a laboratory medicine is one of the most important factors for a reliable interpretation of the results. A large number of standards and guidelines indicate the need for a proper assessment of the uncertainty of measurement results in routine laboratory practice. The available documents generally recommend participation in the proficiency schemes/ external quality control, as well as the internal quality control, in order to primarily verify the quality performance of the method. Although all documents meet the requirements of the International Standard, ISO 15189, the standard itself does not clearly define the method by which the measurement results need to be assessed and there is no harmonization in practice regarding to this. Also, the uncertainty of measurement results is the data relating to the measured result itself, but all factors that influence the interpretation of the measured value, which is ultimately used for diagnosis and monitoring of the patient's treatment, should be taken into account. So in laboratory medicine, an appropriate assessment of the uncertainty of the measurement results should have the ultimate goal of reducing diagnostic uncertainty. However, good professional laboratory practice and understanding analytical aspects of the test for each individual laboratory is necessary to adequately define the uncertainty of measurement results for specific laboratory tests, which helps to implement good clinical practice. Also, setting diagnoses in medicine is a decision with a certain degree of uncertainty, rather than statistically and mathematically calculated conclusion.
在检验医学中，对测量不确定度进行充分评估是可靠解读结果的最重要因素之一。大量标准和指南表明，在常规实验室实践中需要对测量结果的不确定度进行恰当评估。现有文件通常建议参与能力验证计划/外部质量控制以及内部质量控制，以便主要验证方法的质量性能。尽管所有文件均符合国际标准ISO 15189的要求，但该标准本身并未明确界定评估测量结果所需的方法，并且在实践中对此也没有统一的做法。此外，测量结果的不确定度是与测量结果本身相关的数据，但所有影响测量值解读（最终用于患者诊断和治疗监测）的因素都应予以考虑。因此，在检验医学中，对测量结果不确定度进行恰当评估应具有降低诊断不确定度这一最终目标。然而，良好的专业实验室实践以及对每个实验室检测分析方面的理解对于充分界定特定实验室检测的测量结果不确定度是必要的，这有助于实施良好的临床实践。此外，医学诊断是一个具有一定程度不确定性的决策，而非统计和数学计算得出的结论。
