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Eunjeong Gweon 1 Article
Development of a New Approach to Determine the Potency of Bacille Calmette–Guérin Vaccines Using Flow Cytometry
Eunjeong Gweon, Chanwoong Choi, Jaeok Kim, Byungkuk Kim, Hyunkyung Kang, Taejun Park, Sangja Ban, Minseok Bae, Sangjin Park, Jayoung Jeong
Osong Public Health Res Perspect. 2017;8(6):389-396.   Published online December 31, 2017
DOI: https://doi.org/10.24171/j.phrp.2017.8.6.06
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  • 5 Crossref
AbstractAbstract PDF
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.

Citations

Citations to this article as recorded by  
  • Quality analysis of BCG vaccine for bladder cancer immunotherapy using Shewhart control charts
    A. A. Savina, A. A. Voropaev, A. A. Alesina
    Biological Products. Prevention, Diagnosis, Treatm.2024; 24(1): 76.     CrossRef
  • Evaluation of the viability of the Bulgarian BCG vaccine by the adenosine triphosphate assay
    Elitsa Pavlova, Alexander Mihaylov, Tzvetelina Stefanova
    Biotechnology & Biotechnological Equipment.2024;[Epub]     CrossRef
  • Development of a fast and precise potency test for BCG vaccine viability using flow cytometry compared to MTT and colony-forming unit assays
    Hend M. Moghawry, Mohamed E. Rashed, Kareeman Gomaa, Sameh AbdelGhani, Tarek Dishisha
    Scientific Reports.2023;[Epub]     CrossRef
  • Prospects for using flow cytometry in the quality control of live plague vaccines
    N. V. Abzaeva, I. V. Kuznetsova, S. E. Gostischeva, A. M. Zhirov, D. A. Kovalev, A. V. Kostrominov, A. A. Fisun, G. F. Ivanova
    Biological Products. Prevention, Diagnosis, Treatm.2023; 23(4): 560.     CrossRef
  • Recent Developments in the Application of Flow Cytometry to Advance our Understanding of Mycobacteriumtuberculosis Physiology and Pathogenesis
    Trisha Parbhoo, Samantha L. Sampson, Jacoba M. Mouton
    Cytometry Part A.2020; 97(7): 683.     CrossRef

PHRP : Osong Public Health and Research Perspectives