关键词: 卡介苗, ATP, 生物发光(BL), 菌落形成单位(CFU), 荧虫素/荧虫素酶

Abstract: This paper reports our investigation of the possibility of the ultiliza-tion of the Bioluminesceht (BL) technique to substitute the traditional viability count of CFU of current BCG vaccine. First of all we established the basic method of BL technique. Secondly we extracted BCG-ATP with ultrasomic-chloro form method, and got the satisfactory resulte. Our results showed: 1. there was significant dose-dependent-correlation between the concentration of standard ATP and ATP BL value; 2. The correlation coefficient values of BL and CFU of liquid and freezedried vaccine Vere found to be 0.8155 and 0.8484 respectively (p<0.05); 3. The coefficients of varialion (CV) between the BL value of ATP obtained by different lots was 3.2～4.4%, this value is much lower than of CFU (CV=10.4～ 11.2%); 4. The presence of bacterial clumps Within the vaccine has showed to have great influence on the ATP BL values and the CFU (Viabi-lity) count. According to the results, we consider that the BL method can be subs-titute for CFU method, and the BL method has not only showed high sen-sitivity, reproducibility and simplicity but also with high accuracy.

Key words: BCG, ATP, CFU, Bioluminescence (BL), luciferin/luciferase