Guidelines for the Performance Evaluation of In-Vitro Diagnostic Test for the Detection of Norovirus Infection in Korea
Laboratory Medicine Online
;
: 1-6, 2017.
Article
Dans Coréen
| 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.
Texte intégral:
Disponible
Indice:
WPRIM (Pacifique occidental)
Sujet Principal:
Trousses de réactifs pour diagnostic
/
Contrôle social formel
/
Santé publique
/
Épidémies de maladies
/
Norovirus
/
Tests diagnostiques courants
/
Europe
/
Gastroentérite
/
Jurisprudence
/
Corée
Type d'étude:
Etude diagnostique
/
Guide de pratique
/
Étude pronostique
Pays comme sujet:
Asie
/
Europe
langue:
Coréen
Texte intégral:
Laboratory Medicine Online
Année:
2017
Type:
Article
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