Barroso Osquel, Miller John, Squirrell Alan, Westwood Steven
Science, World Anti-Doping Agency, 800 Place Victoria, Montreal, Quebec, H4Z 1B7, Canada.
Bioanalysis. 2012 Jul;4(13):1653-65. doi: 10.4155/bio.12.127.
The standards of laboratory performance of the World Anti-Doping Agency (WADA)-accredited laboratories are defined in the WADA International Standard for Laboratories and its associated Technical Documents. These sets of rules aim to harmonize the production of valid laboratory test results and evidentiary data as well as the reporting of laboratory analytical findings. The determination of anti-doping rule violations in sport made on the basis of analytical quantitative confirmatory analyses for the presence of prohibited threshold substances, in particular, requires the application of specific compliance decision rules, which are established in the WADA Technical Document on Decision Limits. In this article, the use of measurement uncertainty information in the establishment of compliance Decision Limits and in evaluating the performance of a laboratory's quantitative analytical procedures over time and in relation to other laboratories through WADA's External Quality Assessment Scheme program is reviewed and discussed. Furthermore, a perspective is provided on the emerging challenges associated with the harmonization of the quantitative measurement of large-molecular weight biomolecules.
世界反兴奋剂机构(WADA)认可实验室的实验室性能标准在《WADA实验室国际标准》及其相关技术文件中予以界定。这些规则旨在统一有效实验室检测结果和证据数据的产生以及实验室分析结果的报告。特别是,基于对禁用阈值物质存在情况的分析定量确证分析来判定体育赛事中的反兴奋剂规则违规行为,需要应用特定的合规判定规则,这些规则在WADA关于判定限的技术文件中有所规定。本文回顾并讨论了测量不确定度信息在确立合规判定限以及通过WADA的外部质量评估计划来评估实验室定量分析程序随时间推移以及与其他实验室相比的性能方面的应用。此外,还对与大分子量生物分子定量测量协调相关的新出现挑战给出了观点。