Saito Kosuke, Goda Ryoya, Arai Koji, Asahina Kota, Kawabata Mitsuhiko, Uchiyama Hitoshi, Andou Tomohiro, Shimizu Hisao, Takahara Kentaro, Kakehi Masaaki, Yamauchi Saki, Nitta Shin-Ichiro, Suga Takahiro, Fujita Hisashi, Ishikawa Rika, Saito Yoshiro
National Institute of Health Sciences, Kanagawa, Japan.
Daiichi Sankyo Company Ltd, Tokyo, Japan.
Bioanalysis. 2024 Mar;16(6):389-402. doi: 10.4155/bio-2023-0173. Epub 2024 Feb 9.
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.
生物标志物检测方法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不同中心数据的可靠比较和整合至关重要。本综述总结了使用校准曲线参考标准的基于液相色谱-质谱联用（LC-MS）的定量生物标志物检测方法的实验室间研究。讨论了以下几点：报告趋势、参考标准和内标、分析验证参数的评估、研究样本分析以及生物标志物检测数据的标准化。实验室间研究中对这些参数的全面评估有限，需要进一步研究。一些报告提出了应对各实验室生物标志物检测数据差异的方法，有助于进行有组织的研究和数据整合。跨实验室的方法验证对于减少实验室间差异和反映目标生物标志物反应至关重要。
