Lab Med Online.  2017 Jan;7(1):1-6. 10.3343/lmo.2017.7.1.1.

Guidelines for the Performance Evaluation of In-Vitro Diagnostic Test for the Detection of Norovirus Infection in Korea

Affiliations
  • 1Department of Laboratory Medicine, International St.Mary's hospital, Catholic Kwandong University College of Medicine, Incheon, Korea.
  • 2Department of Laboratory Medicine, Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong, Korea. hskim0901@empas.com
  • 3Seegene Medical Foundation, Seoul, Korea.
  • 4Department of Laboratory Medicine, Inje University College of Medicine, Busan, Korea.
  • 5Department of Laboratory Medicine, Dong-A University College of Medicine, Busan, Korea.
  • 6Department of Academic Support Affair, Seegene Inc., Seoul, Korea.
  • 7Standardia Diagnostics, Inc., Yongin, Korea.

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.

Keyword

Norovirus; In-Vitro Diagnostic Device; Evaluation; Guideline
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