FDA-ARGOS 是一个具有公共质量控制参考基因组的数据库，可用于诊断和监管科学。
FDA-ARGOS is a database with public quality-controlled reference genomes for diagnostic use and regulatory science.
机构信息
U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.
U.S. Army Medical Research Institute of Infectious Diseases, 1425 Porter Street, Frederick, MD, 21702, USA.
出版信息
Nat Commun. 2019 Jul 25;10(1):3313. doi: 10.1038/s41467-019-11306-6.
FDA proactively invests in tools to support innovation of emerging technologies, such as infectious disease next generation sequencing (ID-NGS). Here, we introduce FDA-ARGOS quality-controlled reference genomes as a public database for diagnostic purposes and demonstrate its utility on the example of two use cases. We provide quality control metrics for the FDA-ARGOS genomic database resource and outline the need for genome quality gap filling in the public domain. In the first use case, we show more accurate microbial identification of Enterococcus avium from metagenomic samples with FDA-ARGOS reference genomes compared to non-curated GenBank genomes. In the second use case, we demonstrate the utility of FDA-ARGOS reference genomes for Ebola virus target sequence comparison as part of a composite validation strategy for ID-NGS diagnostic tests. The use of FDA-ARGOS as an in silico target sequence comparator tool combined with representative clinical testing could reduce the burden for completing ID-NGS clinical trials.
美国食品和药物管理局积极投资于工具，以支持新兴技术的创新，如传染病下一代测序（ID-NGS）。在这里，我们介绍了 FDA-ARGOS 经过质量控制的参考基因组，作为一个用于诊断目的的公共数据库，并以两个用例为例展示了其效用。我们为 FDA-ARGOS 基因组数据库资源提供了质量控制指标，并概述了在公共领域填补基因组质量差距的必要性。在第一个用例中，我们展示了使用 FDA-ARGOS 参考基因组与非编目 GenBank 基因组相比，从宏基因组样本中对肠球菌进行更准确的微生物鉴定。在第二个用例中，我们展示了 FDA-ARGOS 参考基因组在埃博拉病毒目标序列比较中的效用，作为 ID-NGS 诊断测试综合验证策略的一部分。将 FDA-ARGOS 用作虚拟目标序列比较工具，并结合代表性临床测试，可以减轻完成 ID-NGS 临床试验的负担。
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