Clinical feasibility of dried blood spots: Analytics, validation, and applications
Clinical feasibility of dried blood spots: Analytics, validation, and applications
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DOI：
10.1016/j.jpba.2016.06.026
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发表时间：
2016-10-25
影响因子：
3.4
通讯作者：
Burhenne, Juergen
中科院分区：
文献类型：
--
作者：
Enderle, Yeliz;Foerster, Kathrin;Burhenne, Juergen
干血点（DBS）采样及其特有的优势在分析和临床常规中越来越常见。作为第一个建立在新生儿代谢紊乱筛查，它的使用出现了广泛的临床应用。尽管DBS很容易生成，但在出于临床目的实施DBS时，必须执行特定的分析和临床验证程序，例如治疗药物监测或临床药物试验。欧洲生物分析论坛已经发表了相应的建议。由于没有官方指南，研究人员目前可以自由开发和验证DBS程序。本综述总结并讨论了与其应用相关的已发表临床验证程序，以突出DBS的临床可行性。(C)2016爱思唯尔B.V.保留所有权利。
Dried blood spots (DBS) sampling and their specific advantages are becoming common in analytical and clinical routine. Being first established for metabolic disorder screening in neonates, its use emerged to a broad spectrum of clinical applications. Although DBS are easily generated, the conduction of specific analytical and clinical validation procedures should be obligatory when implementing DBS for clinical purposes, e.g. therapeutic drug monitoring or clinical drug trials. A respective recommendation has already been published by the European Bioanalysis Forum. Since no official guidelines are present, investigators are currently free in DBS procedure development and validation. This review summarizes and discusses published clinical validation procedures in relation to their applications to highlight the clinical feasibility of DBS. (C) 2016 Elsevier B.V. All rights reserved.