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논문 기본 정보

자료유형
학술저널
저자정보
Misook Yang (Ministry of Food and Drug Safety) Jung-Min Jung (Ministry of Food and Drug Safety) Naery Lee (Ministry of Food and Drug Safety) Yanghyun Kim (LG Chem) Eunjeong Park (LG Chem) Jong Won Kim (Ministry of Food and Drug Safety) Jin Tae Hong (Chungbuk University)
저널정보
대한바이러스학회 JOURNAL OF BACTERIOLOGY AND VIROLOGY JOURNAL OF BACTERIOLOGY AND VIROLOGY Vol.51 No.4
발행연도
2021.12
수록면
189 - 199 (11page)

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초록· 키워드

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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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INTRODUCTION
MATERIALS AND METHODS
RESULTS
DISCUSSION
REFERENCES

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