临床质谱

在过去的几十年里，临床检验医学不断发展和多样化。尽管该领域已经取得了重大进展（在方法、仪器、信息学和自动化方面）和转变（远离传统的免疫测定）， 质谱（MS）现在用于多个诊断领域。这包括治疗药物监测、毒理学和内分泌学测试，以及其他筛查领域。

质谱（MS）由于其灵敏度、特异性、通量和多重性，是此类分析物测量的基本通用技术。稳定同位素标记标准品是该分析不可或缺的一部分，如参考文献所示 下面。临床质谱的另一个例子是Joel Braunstein博士和Tim West博士（C2N诊断）在研究人员视角中描述的工作。它们概述了开发的稳定同位素标记动力学（SILK™）测定 测量参与阿尔茨海默病研究的血液来源的蛋白质生物标志物，例如α-β亚型并跟踪其进展。

剑桥同位素实验室公司自豪地提供各种分析标准品，用于临床MS样品的鉴定/定量。这些标准品在分析目的方面具有高度表征，适用于各种样品 类型，并提供各种包装尺寸和格式.

Stable Isotope-Labeled Products for Metabolic Research

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➤ Method for Multiple COVID-19 Drugs Analysis by LC-MS/MS

❛❛Quantitative analysis in clinical diagnostics using mass spectrometry remains a difficult endeavor particularly for small molecules due to chemical similarity and isobaric forms of many substances. Both chromatography and the use of isotopically labeled internal standards to perform small-molecule quantification are required to obtain good quantitative results in many applications. The use of isotopically labeled internal standards remains the best solution as these standards ideally match the chemical behavior of their analytes, thus leading to better quantification than obtained when using structure homologues with physicochemical characteristics.❜❜

– David C. Kasper, PhD | CEO, ARCHIMED Life Science

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常见问题

选择用于临床测量的稳定同位素标记标准品的关键标准是什么？这些外源性化合物必须在结构上独特（在给定的样品类型内）和相似（从物理化学角度来看，与天然靶标相似），并且可通过MS解析（通常首选≥3 Da），无H/D交换（如果使用D标准品），并且理想情况下共洗脱（与其天然靶标）。

如何在工作流程中添加内标？理想情况下，应在混合/移液样品后的第一步添加IS。这在生化上应与目标分析物相同，并精确添加到样品（以及校准品和QC）中，以确保回收率/样品方差校正。

在临床上进行代谢组学测定以及测量和报告这些数据的有用参考是什么？最近发布的“生物分析方法验证：行业指南”文件（美国FDA，2018年5月）概述了方法开发、验证和应用的最新建议和验收标准，以及文档和报告。这些涉及的生物分析方法是人体临床研究，可用于定量确定生物样品中代谢物的水平，例如用于生物标志物分析。

CIL 0.1 mg 包装尺寸的公差是多少？这些特定项目的公差为 ±10%。

参考实例

Yin, Y.; Yu, S.; Qiu, L.; et al. 2019. Establishment of a rapid and simple liquid chromatography tandem mass spectrometry method for measuring aldosterone in urine. J Chromatogr B Analyt Technol Biomed Life Sci, 1113, 84-90. PMID: 30901733
Comhair, S.A.A.; Bochenek, G.; Baicker-McKee, S.; et al. 2018. The utility of biomarkers in diagnosis of aspirin exacerbated respiratory disease. Respir Res, 19(1), 210-216. PMID: 30376852
Mertens, B.; Orti, V.; Vialaret, J.; et al. 2018. Assessing a multiplex-targeted proteomics approach for the clinical diagnosis of periodontitis using saliva samples. Bioanalysis, 10(1), 35-45. PMID: 29243487
Lindahl, A.; Heuchel, R.; Forshed, J.; et al. 2017. Discrimination of pancreatic cancer and pancreatitis by LC-MS metabolomics. Metabolomics, 13(5), 61. PMID 28413374   
Xu, W.; Li, H.; Guan, Q.; et al. 2017. A rapid and simple liquid chromatography-tandem mass spectrometry method for the measurement of testosterone, androstenedione, and dehydroepiandrosterone in human serum. J Clin Lab Anal, 31(5). PMID: 27911021   
Gervasoni, J.; Schiattarella, A.; Primiano, A.; et al. 2016. Simultaneous quantification of 17-hydroxyprogesterone, androstenedione, testosterone and cortisol in human serum by LC-MS/MS using TurboFlow online sample extraction. Clin Biochem, 49(13-14), 998-1003. PMID: 27208555   
Yang, Y.; Rogers, K.; Wardle, R.; et al. 2016. High-throughput measurement of 25-hydroxyvitamin D by LC-MS/MS with separation of the C3-epimer interference for pediatric populations. Clin Chim Acta, 15(454), 102-106. PMID: 26772722   
Peitzsch, M.; Dekkers, T.; Haase, M.; et al. 2015. An LC-MS/MS method for steroid profiling during adrenal venous sampling for investigation of primary aldosteronism. J Steroid Biochem Mol Biol, 145, 75-84. PMID: 25312486