A European Bioanalysis Forum recommendation for requiring a context-of-use statement for successful development and validation of biomarker assays.

IF 16.4 1区化学 Q1 CHEMISTRY, MULTIDISCIPLINARY

Accounts of Chemical Research Pub Date : 2024-01-01 Epub Date: 2024-08-05 DOI:10.1080/17576180.2024.2376436

Kyra J Cowan, Ulrich Kunz, Peter Blattmann, Pratiksha Gulati, Richard Hughes, Lene Andersen, Joanne Goodman, Frazer Lambert, James Lawrence, Daniel Thwaites, Michaela Golob, Robert Nelson, Philip Timmerman

引用次数: 0

Abstract

The European Bioanalysis Forum, alongside key industry stakeholders, has been driving the discussions around the implementation of context-of use for biomarker assays to ensure that these assays are validated appropriately depending on their purpose. Insights into understanding why the implementation of context-of-use in assay strategies has also shown that the key stakeholder, or requester for the biomarker data, is responsible for providing the context-of-use statement for all biomarker assay requests. Experts from across the industry haves repeatedly sought a cross-industry recommended format in which the context-of-use statement could be provided. In this manuscript, the European Bioanalysis Forum suggests a format for this.

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欧洲生物分析论坛关于要求提供使用背景说明以成功开发和验证生物标志物检测方法的建议。

欧洲生物分析论坛与主要的行业利益相关者一起，一直在推动围绕生物标志物检测使用背景的讨论，以确保根据检测目的对这些检测进行适当的验证。在了解为什么要在化验策略中实施 "使用情境 "的深入研究还表明，生物标记物数据的关键利益相关者或请求者有责任为所有生物标记物化验请求提供 "使用情境 "声明。来自各行各业的专家一再寻求一种跨行业的推荐格式，以提供使用背景声明。在本手稿中，欧洲生物分析论坛为此提出了一种格式。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Accounts of Chemical Research 化学-化学综合

CiteScore

31.40

自引率

1.10%

发文量

312

审稿时长

2 months

期刊介绍： Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance. Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.