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Bioluminescence Methods for the Rapid Assay of the Specific Activity of Lyophilized BCG Vaccine

Natalia N Ugarova and Galina Yu Lomakina

The specific activity of a lyophilized BCG vaccine (CFU/mg biomass) is one of the most important characteristics of this product. The classical microbiological method of the BCG vaccine activity assay is very time-consuming and gives results only in 4-5 weeks. The bioluminescent determination of specific activity based on the use of the firefly luciferase-luciferin system makes it possible to greatly shorten the duration of the assay. Since the 1970’s, the ATP method has been successively applied for studying the specific activity of different BCG strains. In 2008, the bioluminescent ATP method was proposed and evaluated for analyzing lyophilized BCG vaccine preparations. The duration of analysis decreased from several weeks to 2 days. This method was used in the International collaborative study to evaluate and establish WHO Reference Reagents for BCG vaccine. In 2016, a new protocol was published describing the use of the ATP method to assay the specific activity of the lyophilized BCG vaccines. The duration of the assay decreased to 2 h. A good correlation between the CFU value and the intracellular ATP content was shown.