Plebani Mario, Sciacovelli Laura, Bernardi Daniela, Aita Ada, Antonelli Giorgia, Padoan Andrea
Department of Laboratory Medicine, University-Hospital of Padova, Via Giustiniani 2, 35128 Padova, Italy.
Department of Laboratory Medicine, University-Hospital of Padova, Via Giustiniani 2, 35128 Padova, Italy.
Clin Biochem. 2018 Jul;57:18-22. doi: 10.1016/j.clinbiochem.2018.01.017. Epub 2018 Feb 2.
The communication of laboratory results to physicians and the quality of reports represent fundamental requirements of the post-analytical phase in order to assure the right interpretation and utilization of laboratory information. Accordingly, the International Standard for clinical laboratories accreditation (ISO 15189) requires that "laboratory reports shall include the information necessary for the interpretation of the examination results". Measurement uncertainty (MU) is an inherent property of any quantitative measurement result which express the lack of knowledge of the true value and quantify the uncertainty of a result, incorporating the factors known to influence it. Even if the MU is not included in the report attributes of ISO 15189 and cannot be considered a post-analytical requirement, it is suggested as an information which should facilitate an appropriate interpretation of quantitative results (quantity values). Therefore, MU has two intended uses: for laboratory professionals, it gives information about the quality of measurements, providing evidence of the compliance with analytical performance characteristics; for physicians (and patients) it may help in interpretation of measurement results, especially when values are compared with reference intervals or clinical decision limits, providing objective information. Here we describe the way that MU should be added to laboratory reports in order to facilitate the interpretation of laboratory results and connecting efforts performed within laboratory to provide more accurate and reliable results with a more objective tool for their interpretation by physicians.
向医生传达实验室结果以及报告的质量是分析后阶段的基本要求,以确保对实验室信息进行正确的解读和利用。因此,临床实验室认可国际标准(ISO 15189)要求“实验室报告应包含解读检验结果所需的信息”。测量不确定度(MU)是任何定量测量结果的固有属性,它表示对真实值缺乏了解,并量化结果的不确定度,其中纳入了已知会影响该结果的因素。即使MU未包含在ISO 15189的报告属性中,也不能将其视为分析后要求,但建议将其作为一种有助于对定量结果(量值)进行适当解读的信息。因此,MU有两个预期用途:对于实验室专业人员而言,它提供有关测量质量的信息,证明符合分析性能特征;对于医生(和患者)而言,它可能有助于解读测量结果,尤其是当将值与参考区间或临床决策限进行比较时,提供客观信息。在此,我们描述了应将MU添加到实验室报告中的方式,以便于解读实验室结果,并将实验室内部为提供更准确可靠结果所做的努力与医生用于解读结果的更客观工具联系起来。