Development of a New Approach to Determine the Potency of Bacille Calmette–Guérin Vaccines Using Flow Cytometry
Autor: | Sangjin Park, Taejun Park, Min Seok Bae, Byungkuk Kim, Jaeok Kim, Chanwoong Choi, Eunjeong Gweon, Sang-ja Ban, Jayoung Jeong, Hyunkyung Kang |
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Rok vydání: | 2017 |
Předmět: |
0301 basic medicine
Fluorescein diacetate medicine.diagnostic_test business.industry flow cytometry Public Health Environmental and Occupational Health Bacille Calmette Guerin Flow cytometry 03 medical and health sciences vaccine potency 030104 developmental biology Infectious Diseases Vaccine Potency CFU ASSAYS Immunology Fluorescent staining Medicine Potency Original Article business BCG vaccine |
Zdroj: | Osong Public Health and Research Perspectives |
ISSN: | 2233-6052 |
DOI: | 10.24171/j.phrp.2017.8.6.06 |
Popis: | Objectives To circumvent the limitations of the current golden standard method, colony-forming unit (CFU) assay, for viability of Bacille Calmette–Guérin (BCG) vaccines, we developed a new method to rapidly and accurately determine the potency of BCG vaccines. Methods Based on flow cytometry (FACS) and fluorescein diacetate (FDA) as the most appropriate fluorescent staining reagent, 17 lots of BCG vaccines for percutaneous administration and 5 lots of BCG vaccines for intradermal administration were analyzed in this study. The percentage of viable cells measured by flow cytometry along with the total number of organisms in BCG vaccines, as determined on a cell counter, was used to quantify the number of viable cells. Results Pearson correlation coefficients of FACS and CFU assays for percutaneous and intradermal BCG vaccines were 0.6962 and 0.7428, respectively, indicating a high correlation. The coefficient of variation value of the FACS assay was less than 7%, which was 11 times lower than that of the CFU assay. Conclusion This study contributes to the evaluation of new potency test method for FACS-based determination of viable cells in BCG vaccines. Accordingly, quality control of BCG vaccines can be significantly improved. |
Databáze: | OpenAIRE |
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