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)
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)
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版权归中华医学会所有。
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