Long-Term Stability of HBV, HCV, and HIV-1 National Reference Standards for in vitro Diagnostic Medical Devices Intended to Be Used for the Nucleic Acid Amplification Test
Author:
Affiliation:
1. Blood Transfusion Research Institute, Korean Red Cross, Wonju, Korea
2. Department of Laboratory Medicine, Chung-Ang University College of Medicine, Seoul, Korea
Funder
Ministry of Food and Drug Safety(MFDS)
Publisher
The Korean Society of Blood Transfusion
Link
http://pdf.medrang.co.kr/KJBT/2018/029/KJBT029-02-06.pdf
Reference19 articles.
1. World Health Organization. WHO consultation on global measurement standards and their use in the in vitro biological diagnostic field. http://www.who.int/bloodproducts/publications/en/Minutes-220804.pdf?ua=1 [Online] (last visited on 26 Feb, 2018)
2. Ministry of Food and Drug Safety. National reference standards for in vitro diagnostic medical devices. https://www.mfds.go.kr/ index.do?mid=1474&cd=304[Online] (last visited on 10 Jul, 2018)
3. Predicting the Stability of Biological Standards and Products
4. Design and analysis of accelerated degradation tests for the stability of biological standards III. Principles of design
5. Design and analysis of accelerated degradation tests for the stability of biological standards I. Properties of maximum likelihood estimators
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