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参考物质在兴奋剂检测分析中的重要性。

The importance of reference materials in doping-control analysis.

机构信息

National Measurement Institute Australia, Pymble, NSW, Australia.

出版信息

Anal Bioanal Chem. 2011 Aug;401(2):483-92. doi: 10.1007/s00216-011-5049-5. Epub 2011 May 12.

DOI:10.1007/s00216-011-5049-5
PMID:21562740
Abstract

Currently a large range of pure substance reference materials are available for calibration of doping-control methods. These materials enable traceability to the International System of Units (SI) for the results generated by World Anti-Doping Agency (WADA)-accredited laboratories. Only a small number of prohibited substances have threshold limits for which quantification is highly important. For these analytes only the highest quality reference materials that are available should be used. Many prohibited substances have no threshold limits and reference materials provide essential identity confirmation. For these reference materials the correct identity is critical and the methods used to assess identity in these cases should be critically evaluated. There is still a lack of certified matrix reference materials to support many aspects of doping analysis. However, in key areas a range of urine matrix materials have been produced for substances with threshold limits, for example 19-norandrosterone and testosterone/epitestosterone (T/E) ratio. These matrix-certified reference materials (CRMs) are an excellent independent means of checking method recovery and bias and will typically be used in method validation and then regularly as quality-control checks. They can be particularly important in the analysis of samples close to threshold limits, in which measurement accuracy becomes critical. Some reference materials for isotope ratio mass spectrometry (IRMS) analysis are available and a matrix material certified for steroid delta values is currently under production. In other new areas, for example the Athlete Biological Passport, peptide hormone testing, designer steroids, and gene doping, reference material needs still need to be thoroughly assessed and prioritised.

摘要

目前,有大量的纯物质标准物质可用于校准兴奋剂控制方法。这些材料使世界反兴奋剂机构(WADA)认可的实验室生成的结果可溯源到国际单位制(SI)。只有少数禁用物质有需要高度定量的阈值限制。对于这些分析物,只应使用最高质量的可用标准物质。许多禁用物质没有阈值限制,标准物质提供了必不可少的身份确认。对于这些标准物质,正确的身份至关重要,用于在这些情况下评估身份的方法应进行严格评估。在许多兴奋剂分析方面仍然缺乏经过认证的基质标准物质来支持。然而,在关键领域,已经为具有阈值限制的物质(例如 19-去甲雄酮和睾酮/表睾酮(T/E)比值)生产了一系列尿液基质材料。这些基质认证的参考物质(CRM)是检查方法回收率和偏差的极好独立手段,通常用于方法验证,然后定期作为质量控制检查。它们在接近阈值限制的样品分析中尤为重要,因为测量精度变得至关重要。一些用于同位素比质谱(IRMS)分析的参考物质可用,并且目前正在生产用于类固醇δ值的基质材料。在其他新领域,例如运动员生物护照、肽激素测试、设计类固醇和基因兴奋剂,仍然需要彻底评估和优先考虑参考物质的需求。

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