需要改进计量可追溯性概念的实施,以便从实验室结果标准化中获益

IF 3.8 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY
Mauro Panteghini
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引用次数: 0

摘要

实验室结果不统一对患者安全构成具体风险。为避免危害,人们一致认为,体外诊断医疗设备(IVD-MD)对临床样本的测量结果应可溯源至更高阶的参照物,并经过调整以得出相同的结果。然而,计量溯源性并不是一种形式上的要求,它必须得到正确实施,而在实践中,有相当数量的测量值并不能做到这一点。利益相关者,如高阶参考品提供商、IVD 制造商和外部质量评估组织者,都负有重大责任,应通过明确、严格地应用国际标准化组织 17511:2020 标准和国际科学机构(如实验室医学可追溯性联合委员会和 IFCC)提供的其他文件中的描述来提高自身的贡献。实验室专业人员应承担起责任,放弃非选择性方法,转而使用具有适当选择性的 IVD-MD,这是正确实施计量学可追溯性不可或缺的先决条件之一。计量可追溯性概念的实用性并非不可能,但要想在标准化方面获得预期效益,就必须对所有相关方进行相关教育和适当培训。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
An improved implementation of metrological traceability concepts is needed to benefit from standardization of laboratory results
Non-harmonization of laboratory results represents a concrete risk for patient safety. To avoid harms, it is agreed that measurements by in vitro diagnostic medical devices (IVD-MD) on clinical samples should be traceable to higher-order references and adjusted to give the same result. However, metrological traceability is not a formal claim and has to be correctly implemented, which in practice does not happen for a non-negligible number of measurands. Stakeholders, such as higher-order reference providers, IVD manufacturers, and External Quality Assessment organizers, have major responsibilities and should improve their contribution by unambiguously and rigorously applying what is described in the International Organization for Standardization 17511:2020 standard and other documents provided by the international scientific bodies, such as Joint Committee on Traceability in Laboratory Medicine and IFCC. For their part, laboratory professionals should take responsibility to abandon non-selective methods and move to IVD-MDs displaying proper selectivity, which is one of the indispensable prerequisites for the correct implementation of metrological traceability. The practicality of metrological traceability concepts is not impossible but relevant education and appropriate training of all involved stakeholders are essential to obtain the expected benefits in terms of standardization.
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来源期刊
Clinical chemistry and laboratory medicine
Clinical chemistry and laboratory medicine 医学-医学实验技术
CiteScore
11.30
自引率
16.20%
发文量
306
审稿时长
3 months
期刊介绍: Clinical Chemistry and Laboratory Medicine (CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor over 3. CCLM is issued monthly, and it is published in print and electronically. CCLM is the official journal of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and publishes regularly EFLM recommendations and news. CCLM is the official journal of the National Societies from Austria (ÖGLMKC); Belgium (RBSLM); Germany (DGKL); Hungary (MLDT); Ireland (ACBI); Italy (SIBioC); Portugal (SPML); and Slovenia (SZKK); and it is affiliated to AACB (Australia) and SFBC (France). Topics: - clinical biochemistry - clinical genomics and molecular biology - clinical haematology and coagulation - clinical immunology and autoimmunity - clinical microbiology - drug monitoring and analysis - evaluation of diagnostic biomarkers - disease-oriented topics (cardiovascular disease, cancer diagnostics, diabetes) - new reagents, instrumentation and technologies - new methodologies - reference materials and methods - reference values and decision limits - quality and safety in laboratory medicine - translational laboratory medicine - clinical metrology Follow @cclm_degruyter on Twitter!
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