Evaluation of Quality Control Methods for Foot-And-Mouth Disease Vaccines by High-Performance Liquid Chromatography
Foot-and-mouth disease (FMD) is considered one of the highly contagious viral infections affecting livestock. In Korea, an FMD vaccination policy has been implemented nationwide since 2010 for the prevention and control of FMD. Since the vaccines are imported from various countries, standardized qua...
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| Format: | Article |
| Language: | English |
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MDPI AG
2020-03-01
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| Series: | Pathogens |
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| Online Access: | https://www.mdpi.com/2076-0817/9/3/194 |
| _version_ | 1828347614685298688 |
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| author | Mun-Hyeon Kim Seon-Jong Yun Yeon-Hee Kim Hyang-Sim Lee Ji-Yeon Kim Ji-Ye Kim JeongWoo Kang Yong-Sang Kim Min-Goo Seo |
| author_facet | Mun-Hyeon Kim Seon-Jong Yun Yeon-Hee Kim Hyang-Sim Lee Ji-Yeon Kim Ji-Ye Kim JeongWoo Kang Yong-Sang Kim Min-Goo Seo |
| author_sort | Mun-Hyeon Kim |
| collection | DOAJ |
| description | Foot-and-mouth disease (FMD) is considered one of the highly contagious viral infections affecting livestock. In Korea, an FMD vaccination policy has been implemented nationwide since 2010 for the prevention and control of FMD. Since the vaccines are imported from various countries, standardized quality control measures are critical. In this study, we aimed to validate a high-performance liquid chromatography (HPLC) device in the Animal and Plant Quarantine Agency lab and identify an appropriate FMD vaccine pretreatment method for HPLC—a simple, reliable, and practical method to measure antigen content. Based on the analyses of specificity, linearity, accuracy, repeatability, intermediate precision, limits of detection, and limits of quantification using FMD standard samples, we validated the method using a standard material. Overall, we confirmed that the HPLC technique is effective for the quantitative assessment of the FMD virus 146S antigen in Korea. Using commercial FMD vaccines, we evaluated three separation methods and identified the method using n-pentanol and trichloroethylene as optimal for HPLC analysis. Our HPLC method was effective for the analytical detection of the antigen content in FMD vaccine, and it may be useful as a reference method for national lot-release testing. |
| first_indexed | 2024-04-14T00:42:00Z |
| format | Article |
| id | doaj.art-f94626f364da4ddda75a49817f858d5d |
| institution | Directory Open Access Journal |
| issn | 2076-0817 |
| language | English |
| last_indexed | 2024-04-14T00:42:00Z |
| publishDate | 2020-03-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pathogens |
| spelling | doaj.art-f94626f364da4ddda75a49817f858d5d2022-12-22T02:22:09ZengMDPI AGPathogens2076-08172020-03-019319410.3390/pathogens9030194pathogens9030194Evaluation of Quality Control Methods for Foot-And-Mouth Disease Vaccines by High-Performance Liquid ChromatographyMun-Hyeon Kim0Seon-Jong Yun1Yeon-Hee Kim2Hyang-Sim Lee3Ji-Yeon Kim4Ji-Ye Kim5JeongWoo Kang6Yong-Sang Kim7Min-Goo Seo8Animal and Plant Quarantine Agency, Gimcheon, Gyeongbuk 39660, KoreaAnimal and Plant Quarantine Agency, Gimcheon, Gyeongbuk 39660, KoreaAnimal and Plant Quarantine Agency, Gimcheon, Gyeongbuk 39660, KoreaAnimal and Plant Quarantine Agency, Gimcheon, Gyeongbuk 39660, KoreaAnimal and Plant Quarantine Agency, Gimcheon, Gyeongbuk 39660, KoreaAnimal and Plant Quarantine Agency, Gimcheon, Gyeongbuk 39660, KoreaAnimal and Plant Quarantine Agency, Gimcheon, Gyeongbuk 39660, KoreaAnimal and Plant Quarantine Agency, Gimcheon, Gyeongbuk 39660, KoreaAnimal and Plant Quarantine Agency, Gimcheon, Gyeongbuk 39660, KoreaFoot-and-mouth disease (FMD) is considered one of the highly contagious viral infections affecting livestock. In Korea, an FMD vaccination policy has been implemented nationwide since 2010 for the prevention and control of FMD. Since the vaccines are imported from various countries, standardized quality control measures are critical. In this study, we aimed to validate a high-performance liquid chromatography (HPLC) device in the Animal and Plant Quarantine Agency lab and identify an appropriate FMD vaccine pretreatment method for HPLC—a simple, reliable, and practical method to measure antigen content. Based on the analyses of specificity, linearity, accuracy, repeatability, intermediate precision, limits of detection, and limits of quantification using FMD standard samples, we validated the method using a standard material. Overall, we confirmed that the HPLC technique is effective for the quantitative assessment of the FMD virus 146S antigen in Korea. Using commercial FMD vaccines, we evaluated three separation methods and identified the method using n-pentanol and trichloroethylene as optimal for HPLC analysis. Our HPLC method was effective for the analytical detection of the antigen content in FMD vaccine, and it may be useful as a reference method for national lot-release testing.https://www.mdpi.com/2076-0817/9/3/194146s antigenevaluationfoot-and-mouth diseasehigh-performance liquid chromatographynational lot-release testingvaccinevalidation |
| spellingShingle | Mun-Hyeon Kim Seon-Jong Yun Yeon-Hee Kim Hyang-Sim Lee Ji-Yeon Kim Ji-Ye Kim JeongWoo Kang Yong-Sang Kim Min-Goo Seo Evaluation of Quality Control Methods for Foot-And-Mouth Disease Vaccines by High-Performance Liquid Chromatography Pathogens 146s antigen evaluation foot-and-mouth disease high-performance liquid chromatography national lot-release testing vaccine validation |
| title | Evaluation of Quality Control Methods for Foot-And-Mouth Disease Vaccines by High-Performance Liquid Chromatography |
| title_full | Evaluation of Quality Control Methods for Foot-And-Mouth Disease Vaccines by High-Performance Liquid Chromatography |
| title_fullStr | Evaluation of Quality Control Methods for Foot-And-Mouth Disease Vaccines by High-Performance Liquid Chromatography |
| title_full_unstemmed | Evaluation of Quality Control Methods for Foot-And-Mouth Disease Vaccines by High-Performance Liquid Chromatography |
| title_short | Evaluation of Quality Control Methods for Foot-And-Mouth Disease Vaccines by High-Performance Liquid Chromatography |
| title_sort | evaluation of quality control methods for foot and mouth disease vaccines by high performance liquid chromatography |
| topic | 146s antigen evaluation foot-and-mouth disease high-performance liquid chromatography national lot-release testing vaccine validation |
| url | https://www.mdpi.com/2076-0817/9/3/194 |
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