• 主题
高级搜索  >
历史搜索 清空历史
首页> 美国政府科技报告 >Quality, Regulation and Clinical Utility of Laboratory-developed Molecular Tests. Technology Assessment Report
【24h】

Quality, Regulation and Clinical Utility of Laboratory-developed Molecular Tests. Technology Assessment Report

机译：实验室开发的分子测试的质量，调节和临床应用。技术评估报告

获取原文
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

In this report, the authors use the term-molecular test (MT) interchangeably with the term-molecular genetic test. They adopted the definition of molecular genetic test recommended by the Genetic Work Group of the Clinical Laboratory Improvement Advisory Committee. The Work Group defined a genetic molecular test as-an analysis performed on human DNA or RNA to detect heritable or acquired disease-related genotypes, mutations, or phenotypes for clinical purposes. According to this definition, cytogenetic tests, which are performed on human chromosomes, and biochemical genetic tests, which analyze human proteins and certain metabolites, are beyond the scope of this report. However, molecular cytogenetic tests (e.g., the tests using the fluorescence in situ hybridization (FISH) technology) in which analyses cross both the chromosome and the DNA levels are included in this report. In this report, they also consider a test performed on pathogen (e.g., bacterial, viral or fungal) DNA or RNA as a molecular test if the purpose of the test is to diagnose an infectious disease caused by the pathogen in human. In accordance with the objectives outlined in the scope of work, this horizon scan only includes molecular tests of potential clinical relevance to the Medicare over-65-year-old population as of October 31, 2008. Particularly, molecular tests for the following purposes are addressed: Tests used for diagnostic purposes in symptomatic individuals, tests used as prognostic indicators, tests used to monitor response to therapy, and tests used to choose therapies for a known disease entity or used to adjust medication dosing. Excluded from this report are molecular tests used primarily for blood supply screening, tissue typing, epidemiological surveillance, pure research, and forensic purposes. Tests used to screen for inherited diseases of metabolism or other conditions of greater relevance to the pediatric population (e.g., the diagnostic or screening tests for cystic fibrosis) are also beyond the scope of this report.

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号