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KMID : 0921620210510040189
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Journal of Bacteriology and Virology
2021 Volume.51 No. 4 p.189 ~ p.199
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Establishment of the 1st National Reference Standard for Sabin Inactivated Poliomyelitis Vaccine in Korea
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Yang Mi-Sook
Jung Jung-Min
Lee Nae-Ry
Kim Yang-Hyun
Park Eun-Jeong
Kim Jong-Won
Hong Jin-Tae
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Abstract
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In 2019, the first Sabin strain inactivated poliomyelitis vaccine was approved in Korea. It was necessary establishment of national reference standards of that vaccine for consistent quality control and standardization since international standards are provided only in small quantities per year. Therefore, Sabin strain inactivated poliomyelitis vaccine standard candidate was produced in 2019. In this study, we tried to establish the D-antigen content of the candidate standard through collaborate study with five institutions and six laboratories participated in the collaborate research. The candidate standard was set up value of DU/mL with Salk strain International Standard (12/104, NIBSC) and the SDU/mL value was established with the Sabin International Standard (17/160, NIBSC). The D-Ag contents (DU/mL and SDU/mL) derived from each laboratory were calculate using the CombiStat program and analyzed for statistical significance. Earlier this year, the candidate standard was registered as the 1st national reference standard of Sabin strain inactivated poliomyelitis vaccine and the D-Ag contents of the standard was assigned 47, 129, 262 DU/mL and 48, 106, and 193 SDU/mL by ?each type (Type 1, 2, 3,). Because of established of national standard, it will help consistent quality control and standardization of the Sabin strain inactivated poliomyelitis vaccines.
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KEYWORD
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Poliovirus vaccine, Sabin strain, Inactivated vaccine, National reference standard, D-antigen content assay, Quality control
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