Interlaboratory evaluation of LC-MS-based biomarker assays.

IF 16.4 1区化学 Q1 CHEMISTRY, MULTIDISCIPLINARY

Accounts of Chemical Research Pub Date : 2024-03-01 Epub Date: 2024-02-09 DOI:10.4155/bio-2023-0173

Kosuke Saito, Ryoya Goda, Koji Arai, Kota Asahina, Mitsuhiko Kawabata, Hitoshi Uchiyama, Tomohiro Andou, Hisao Shimizu, Kentaro Takahara, Masaaki Kakehi, Saki Yamauchi, Shin-Ichiro Nitta, Takahiro Suga, Hisashi Fujita, Rika Ishikawa, Yoshiro Saito

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Abstract

Validation of biomarker assays is crucial for effective drug development and clinical applications. Interlaboratory reproducibility is vital for reliable comparison and combination of data from different centers. This review summarizes interlaboratory studies of quantitative LC-MS-based biomarker assays using reference standards for calibration curves. The following points are discussed: trends in reports, reference and internal standards, evaluation of analytical validation parameters, study sample analysis and normalization of biomarker assay data. Full evaluation of these parameters in interlaboratory studies is limited, necessitating further research. Some reports suggest methods to address variations in biomarker assay data among laboratories, facilitating organized studies and data combination. Method validation across laboratories is crucial for reducing interlaboratory differences and reflecting target biomarker responses.

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基于液相色谱-质谱联用技术的生物标志物测定的实验室间评估。

生物标记分析的验证对于有效的药物开发和临床应用至关重要。实验室间的可重复性对于可靠地比较和组合来自不同中心的数据至关重要。本综述总结了使用校准曲线参考标准对基于 LC-MS 的生物标记物定量检测进行的实验室间研究。文章讨论了以下几点：报告趋势、参考标准和内部标准、分析验证参数评估、研究样本分析和生物标记物检测数据归一化。在实验室间研究中对这些参数的全面评估是有限的，需要进一步研究。一些报告提出了解决实验室间生物标志物检测数据差异的方法，有助于组织研究和数据合并。实验室间的方法验证对于减少实验室间差异和反映目标生物标记物反应至关重要。

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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.