National Quality Control Laboratory of Drug and Food (NQCLDF), Indonesian FDA, Central Jakarta, Indonesia.
Arch Razi Inst. 2024 Feb 1;79(1):240-245. doi: 10.32592/ARI.2024.79.1.240. eCollection 2024 Feb.
The BCG vaccines on the market have employed a (M. bovis) sub-strains derived from the initial strain. To date, there has been no recommendation regarding the sub-strains with the highest effectiveness when administered to humans. Because it remains the standard for Tuberculosis treatment, the quality of the BCG vaccine must be verified. The viability test is one of the parameters for BCG vaccine quality control. The culture method has become the gold standard for viability testing with various testing media. The present study aimed to evaluate the performance of Lowenstein Jensen (LJ) and Ogawa media for the viability test of Pasteur 1173P2 and Russian (Moscow) - 384 sub-strains of in the BCG vaccine. The number of culturable particles of each sub-strain in the BCG vaccine was estimated and statistically evaluated using the t-test. The colonies of the Pasteur 1173P2 have characteristics; tended to clump on both mediums with tiny, rough, and pale yellow/cream colors. Although the colony character of the Russian (Moscow) - 384 generally has similar feature, it did not cluster and had a smooth texture. In terms of growth rate, LJ and Ogawa media performed similarly for Pasteur 1173P2 and Russian (Moscow) - 384 sub-strains. Maximum growth is reached by the fifth week. The culturable particles of Pasteur P1173P2 sub-strains did not differ between mediums. Whereas the growth of the Russian (Moscow) - 384 sub-strains was statistically better on Ogawa media. The results of this study reveal that the performance of the media used for determining the number of culturable particles is based on the sub-strains of present in the BCG vaccine.
市面上的卡介苗（BCG）疫苗采用了源自原始菌株的 （牛型分枝杆菌）亚株。迄今为止，还没有关于对人类接种效果最高的亚株的推荐。由于它仍然是结核病治疗的标准，BCG 疫苗的质量必须得到验证。生存能力测试是 BCG 疫苗质量控制的参数之一。培养方法已成为各种测试介质中生存能力测试的金标准。本研究旨在评估 Lowenstein Jensen（LJ）和 Ogawa 培养基在评估卡介苗中巴斯德 1173P2 和俄罗斯（莫斯科）-384 亚株的生存能力测试中的性能。使用 t 检验估计每种亚株在 BCG 疫苗中的可培养颗粒数，并进行统计学评估。巴斯德 1173P2 的菌落特征；在两种培养基上都倾向于聚集，呈微小、粗糙、淡黄色/奶油色。尽管俄罗斯（莫斯科）-384 的菌落特征通常具有相似的特征，但它没有聚集，质地光滑。在生长速度方面，LJ 和 Ogawa 培养基对巴斯德 1173P2 和俄罗斯（莫斯科）-384 亚株的表现相似。第五周达到最大生长。巴斯德 P1173P2 亚株在培养基之间的可培养颗粒数没有差异。而俄罗斯（莫斯科）-384 亚株在 Ogawa 培养基上的生长情况统计学上更好。本研究结果表明，用于确定可培养颗粒数的培养基的性能取决于 BCG 疫苗中存在的 亚株。
