The 2020 Wild, Wild West of Diagnostics
Regarding regulatory oversight of laboratorydeveloped tests (LDT) for molecular diagnostics, the Q7 Food and Drug Administration (FDA) often refers to the LDT space as the “Wild, Wild West,” making it seem like laboratories are all going rogue with respect to Clinical Laboratory Improvement Amendmen...
- Autores:
- Tipo de recurso:
- Article of investigation
- Fecha de publicación:
- 2020
- Institución:
- Universidad de Bogotá Jorge Tadeo Lozano
- Repositorio:
- Expeditio: repositorio UTadeo
- Idioma:
- eng
- OAI Identifier:
- oai:expeditiorepositorio.utadeo.edu.co:20.500.12010/12463
- Acceso en línea:
- https://doi.org/10.1016/j.yamp.2020.06.001
http://hdl.handle.net/20.500.12010/12463
- Palabra clave:
- Pandemic
SARS-CoV-2
COVID-18
Laboratory-developed tests
Regulatory oversight
Emergency use authorization
Síndrome respiratorio agudo grave
COVID-19
SARS-CoV-2
Coronavirus
- Rights
- License
- Acceso restringido