Guidelines for the Performance Evaluation of In-Vitro Diagnostic Test for the Detection of Norovirus Infection in Korea
Laboratory Medicine Online
;
: 1-6, 2017.
Artículo
en Coreano
| WPRIM
| ID: wpr-100539
ABSTRACT
Norovirus is a leading cause of epidemic and sporadic acute gastroenteritis worldwide. Rapid and accurate detection of norovirus is essential for the prevention and control of norovirus outbreaks. The purpose of this study was to propose and develop a process for establishing appropriate standardized guidelines for the approval and evaluation of in vitro diagnostic medical devices (IVDD) for norovirus detection in Korea based on the related laws, regulations, and guidelines of USA, Europe, and Korea. We expect that this study could be used for diagnostic test standardization and the approval and evaluation of domestic norovirus diagnostic devices. We also expect the results will contribute to industrial expansion and public health promotion.
Texto completo:
Disponible
Índice:
WPRIM (Pacífico Occidental)
Asunto principal:
Juego de Reactivos para Diagnóstico
/
Control Social Formal
/
Salud Pública
/
Brotes de Enfermedades
/
Norovirus
/
Pruebas Diagnósticas de Rutina
/
Europa (Continente)
/
Gastroenteritis
/
Jurisprudencia
/
Corea (Geográfico)
Tipo de estudio:
Estudio diagnóstico
/
Guía de Práctica Clínica
/
Estudio pronóstico
País/Región como asunto:
Asia
/
Europa
Idioma:
Coreano
Revista:
Laboratory Medicine Online
Año:
2017
Tipo del documento:
Artículo
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