Guidelines for the Performance Evaluation of In-Vitro Diagnostic Test for the Detection of Norovirus Infection in Korea.
- Author:
Jayoung KIM
1
;
Hyun Soo KIM
;
Sunwha LEE
;
Seoung Hwan OH
;
Kwang Sook WOO
;
Seong Youl KIM
;
Eui Kee MIN
Author Information
- Publication Type:Original Article
- Keywords: Norovirus; In-Vitro Diagnostic Device; Evaluation; Guideline
- MeSH: Diagnostic Tests, Routine*; Disease Outbreaks; Europe; Gastroenteritis; Jurisprudence; Korea*; Norovirus*; Public Health; Reagent Kits, Diagnostic; Social Control, Formal
- From:Laboratory Medicine Online 2017;7(1):1-6
- CountryRepublic of Korea
- Language:Korean
- 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.
