Interlaboratory evaluation of LC-MS-based biomarker assays.

IF 1.9 4区医学 Q3 BIOCHEMICAL RESEARCH METHODS Bioanalysis 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

Bioanalysis BIOCHEMICAL RESEARCH METHODS-CHEMISTRY, ANALYTICAL

CiteScore

3.30

自引率

16.70%

发文量

审稿时长

2 months

期刊介绍： Reliable data obtained from selective, sensitive and reproducible analysis of xenobiotics and biotics in biological samples is a fundamental and crucial part of every successful drug development program. The same principles can also apply to many other areas of research such as forensic science, toxicology and sports doping testing. The bioanalytical field incorporates sophisticated techniques linking sample preparation and advanced separations with MS and NMR detection systems, automation and robotics. Standards set by regulatory bodies regarding method development and validation increasingly define the boundaries between speed and quality. Bioanalysis is a progressive discipline for which the future holds many exciting opportunities to further reduce sample volumes, analysis cost and environmental impact, as well as to improve sensitivity, specificity, accuracy, efficiency, assay throughput, data quality, data handling and processing. The journal Bioanalysis focuses on the techniques and methods used for the detection or quantitative study of analytes in human or animal biological samples. Bioanalysis encourages the submission of articles describing forward-looking applications, including biosensors, microfluidics, miniaturized analytical devices, and new hyphenated and multi-dimensional techniques. Bioanalysis delivers essential information in concise, at-a-glance article formats. Key advances in the field are reported and analyzed by international experts, providing an authoritative but accessible forum for the modern bioanalyst.