| Autor: |
Tom Slezak, Suvarna Nadendla, Jonathan E. Allen, Christopher P. Stefan, William Klimke, Timothy D. Minogue, Adrienne T. Hall, Luke Tallon, Randal J. Schoepp, Lisa Sadzewicz, Jeffrey W. Koehler, Uwe Scherf, Martin Shumway, Dayanara Lebron Aldea, Yi H. Yan, Heike Sichtig, Eneida L. Hatcher, Stephen Lovell |
| Rok vydání: |
2018 |
| Předmět: |
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| Popis: |
Infectious disease next generation sequencing (ID-NGS) diagnostics are on the cusp of revolutionizing the clinical market. To facilitate this transition, FDA proactively invested in tools to support innovation of emerging technologies. FDA and collaborators established a publicly available database, FDA dAtabase for Regulatory-Grade micrObial Sequences (FDA-ARGOS), as a tool to fill reference database gaps with quality-controlled genomes. This manuscript discusses quality control metrics for the proposed FDA-ARGOS genomic resource and outlines the need for quality-controlled genome gap filling in the public domain. Here, we also present three case studies showcasing potential applications for FDA-ARGOS in infectious disease diagnostics, specifically: assay design, reference database and in silico sequence comparison in combination with representative microbial organism wet lab testing; a novel composite validation strategy for ID-NGS diagnostics. The use of FDA-ARGOS as an in silico comparator tool could reduce the burden for completing ID-NGS clinical trials. In addition, use cases identifying Enterococcus avium and Ebola virus (Zaire ebolavirus variant Makona) demonstrate the utility of FDA-ARGOS as a reference database for independent performance validation of new tests and for documenting how one would use this database as an in silico sequence target comparator tool for ID-NGS validation, respectively. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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