Recommended Principles and Practices for Validating Clinical Molecular Pathology Tests
Recommended Principles and Practices for Validating Clinical Molecular Pathology Tests
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DOI：
10.1043/1543-2165-133.5.743
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发表时间：
2009-05-01
影响因子：
4.6
通讯作者：
Gulley, Margaret L.
中科院分区：
文献类型：
--
作者：
Jennings, Lawrence;Van Deerlin, Vivianna M.;Gulley, Margaret L.
背景。-基于DNA和RNA的测试的使用持续增长，用于遗传性疾病、传染病、癌症、身份测试、人类白细胞抗原分型和药物遗传学等各种应用。疾病分子基础知识的巨大增长以及技术能力的进步，部分推动了进展。除了临床实用性的要求外，每种分子测试也可能具有在临床实施之前必须仔细考虑的局限性。通过测试验证过程建立并记录分析和临床性能特征以及测试限制。描述已确立的检测验证原则，沿着美国的相关法规，以便为临床实验室引入分子检测提供合理的方法。数据来源。- PubMed对已发表的文献、已发表的指南和来自国家和国际专业组织的在线信息进行了综述。这些资源和建议为验证临床试验提供了一个框架。(Arch Pathol Lab Med.2009; 133：743-755）
Context.-The use of DNA-and RNA-based tests continues to grow for applications as varied as inherited disease, infectious disease, cancer, identity testing, human leukocyte antigen typing, and pharmacogenetics. Progress is driven in part by the huge growth in knowledge about the molecular basis of disease coupled with advancements in technologic capabilities. In addition to requirements for clinical utility, every molecular test also may have limitations that must be carefully considered before clinical implementation. Analytic and clinical performance characteristics as well as test limitations are established and documented through the process of test validation.Objective.-To describe the established principles of test validation, along with relevant regulations in the United States, in order to provide a rational approach to introducing molecular tests into the clinical laboratory.Data Sources.-PubMed review of published literature, published guidelines, and online information from national and international professional organizations.Conclusions.-These resources and recommendations provide a framework for validating clinical tests. (Arch Pathol Lab Med. 2009; 133: 743-755)