Osong Public Health and Research Perspectives

Korea Disease Control and Prevention Agency (질병관리청)
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Development of a New Approach to Determine the Potency of Bacille Calmette-Guérin Vaccines Using Flow Cytometry

  • Gweon, Eunjeong (Biologics Research Division, National Institute of Food and Drug Safety Evaluation) ;
  • Choi, Chanwoong (Biologics Research Division, National Institute of Food and Drug Safety Evaluation) ;
  • Kim, Jaeok (Biologics Research Division, National Institute of Food and Drug Safety Evaluation) ;
  • Kim, Byungkuk (Biologics Research Division, National Institute of Food and Drug Safety Evaluation) ;
  • Kang, Hyunkyung (Biologics Research Division, National Institute of Food and Drug Safety Evaluation) ;
  • Park, Taejun (Biologics Research Division, National Institute of Food and Drug Safety Evaluation) ;
  • Ban, Sangja (Biologics Research Division, National Institute of Food and Drug Safety Evaluation) ;
  • Bae, Minseok (Biologics Research Division, National Institute of Food and Drug Safety Evaluation) ;
  • Park, Sangjin (Biologics Research Division, National Institute of Food and Drug Safety Evaluation) ;
  • Jeong, Jayoung (Biologics Research Division, National Institute of Food and Drug Safety Evaluation)
  • Received : 2017.04.25
  • Accepted : 2017.11.26
  • Published : 2017.12.30
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Abstract

Objectives: To circumvent the limitations of the current golden standard method, colony-forming unit (CFU) assay, for viability of Bacille Calmette-$Gu{\acute{e}}rin$ (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.

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Acknowledgement

Supported by : Ministry of Food and Drug Safety

Cited by

  1. Recent Developments in the Application of Flow Cytometry to Advance our Understanding of Mycobacterium tuberculosis Physiology and Pathogenesis vol.97, pp.7, 2017, https://doi.org/10.1002/cyto.a.24030