专题笔谈
ENGLISH ABSTRACT
解读新ISO指南80:质控品实验室内部制备指南
李婷婷
王薇
赵海建
王治国
作者及单位信息
·
DOI: 10.3760/cma.j.issn.1009-9158.2016.12.027
Interpretation of the new ISO Guide 80—Guidance for the in-house preparation of quality control materials in the laboratory
Li Tingting
Wang Wei
Zhao Haijian
Wang Zhiguo
Authors Info & Affiliations
Li Tingting
National Center for Clinical Laboratories/Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology, Beijing 100730, China
Wang Wei
Zhao Haijian
Wang Zhiguo
·
DOI: 10.3760/cma.j.issn.1009-9158.2016.12.027
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摘要

标准物质(RMs)已广泛应用于测量实验室,且做到使用最合适特定应用的材料是关键。有证标准物质(CRMs)被用于方法确认、检测系统的校准和检测系统中涉及测量结果正确度的所有其他方面的评价。对于质量控制、精密度研究和操作者之间变异性的检查,其对结果只是进行相对地比较,任何合适的标准物质都可以被采用。国际标准化组织/标准物质委员会(ISO/REMCO)已经起草了ISO指南80——质控品(QCMs)内部制备指南性文件。QCMs主要用于监测已确认过的实验方法的性能,能够检出方法随时间的变化或出现的统计失控制状况。QCMs是标准物质,因此为了预期的用途必须具有足够均匀性和稳定性。QCMs通常由实验室人员内部制备,仅供本实验室内部使用,因此内部制备QCMs的要求要低于CRMs。QCMs的质量评价应包括均匀性和稳定性评价,并且在使用前,材料的有限特征能够提供其相关特性值的指征和它们的变化。(中华检验医学杂志,2016, 39:988-990)

参考标准;质量控制
ABSTRACT

Reference materials (RMs) have been widely used in measurement laboratories, and it is critical to recognise that the material most appropriate for a particular application should be used. Certified reference materials (CRMs) are used for method validation, the calibration of a measurement system and all other aspects of the evaluation of the measurement system where the trueness of the measurement result is required. For other aspects, such as quality control, precision studies, the checking of the variability between operators, where the results are compared relatively, any suitable reference material can be used. ISO/REMCO, the ISO Committee on Reference Materials, has prepared ISO Guide 80, a guidance document for the in-house preparation of quality control materials (QCMs). QCMs are mostly used to monitor the performance of laboratory methods that have already been validated over time to be able to detect change or when a method goes out of statistical control. QCMs are RMs and have to be sufficiently homogeneous and stable for the intended use. QCMs are usually prepared in-house by laboratory staff for in-house use only, and therefore, the requirements for "in-house" QCMs are less demanding than those for a CRM.The quality assessment of QCMs should involve homogeneity and stability assessments, and a limited characterization of the material to provide an indication of its relevant property values and their variation, prior to use.( Chin J Lab Med, 2016, 39: 988-990)

Reference standard;Quality control
Wang Zhiguo, Email: nc.defgrabo.lccngnawgz
引用本文

李婷婷,王薇,赵海建,等. 解读新ISO指南80:质控品实验室内部制备指南[J]. 中华检验医学杂志,2016,39(12):988-990.

DOI:10.3760/cma.j.issn.1009-9158.2016.12.027

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标准物质(reference materials,RMs)以各种目的被广泛应用于测量实验室,且需根据不同的应用选择最合适的材料。有证标准物质(certified reference materials,CRMs)是具有由计量学有效程序赋予的特性值和相关的不确定度的物质,其主要用于校准或方法确认和控制来保证测量结果的正确度。有些情况,对检测过程进行部分评价并不需要使用CRMs。对于有关一致性为目的的质量控制,必须证明的是检测系统处于再现性控制之中,以相同方式执行并提供一致的结果,即这种情况下测量结果的正确度并不重要,对标准物质质量的唯一要求是它们足够均匀和稳定。CRMs是由已建立的标准物质生产者生产,并可在市场上购买到,而那些有时被称为质控样品或检查品的物质,常常由实验室自己制备供自己内部使用。
ISO/REMCO即ISO标准物质委员会已经起草了ISO指南80——质控品(Quality control materials,QCMs)内部制备指南性文件 [ 1 ]。QCMs是RMs,所以ISO指南34 [ 2 ]和ISO指南35 [ 3 ]中关于标准物质生产的详细说明也适用于QCMs的制备。然而,制备只供内部使用的QCMs的要求要低于CRMs,例如,在运输方面的问题。对于这种类型的标准物质不需要建立计量学溯源性,不确定度估计和广泛的稳定性试验,这些过程在ISO指南80 [ 1 ]中也没有描述。
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参考文献
[1]
ISO Guide 80. Guidance for the in-house preparation of quality control materials[S]. Geneva, Switzerland:ISO, 2014.
[2]
ISO Guide 34. General requirements for the competence of reference material producers[S]. Geneva, Switzerland:ISO, 2009.
[3]
ISO Guide 35. Reference materials—general and statistical principles for certification[S]. Geneva, Switzerland:ISO, 2006.
[4]
ISO 7870-1. Control charts—Part 1: general guidelines[S]. Geneva, Switzerland:ISO, 2014.
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ISO 7873. Control charts for arithmetic means with warning limits[S]. Geneva, Switzerland:ISO, 1993.
[6]
ISO 7870-3 (2012) Control charts—Part 3: acceptance control charts[S]. Geneva, Switzerland:ISO, 2012.
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ISO 7870-2. Control charts—Part 2: Shewhart control charts[S]. Geneva, Switzerland:ISO, 2013.
[8]
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万方数据
[9]
ISO Guide 31. Reference materials—Contents of certificates and labels[S]. Geneva, Switzerland:ISO, 2000.
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王治国,电子信箱: nc.defgrabo.lccngnawgz
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