我国生产用卡介菌的传代稳定性

目的研究我国生产用卡介菌上海株在传代过程中分子遗传学特性的稳定性。方法应用多重PCR法,对我国生产用卡介菌上海株工作种子批及其不同代次菌的各缺失区、插入序列IS6110及基因座SenX3-RenX3串联重复序列拷贝数进行检测。结果我国生产用卡介菌上海株的工作种子批及其第6、9、12代菌均缺失RD1、RD2,未缺失RD8、RD14、RD16、nRD18及RDDenmark/Glaxo;含有1个IS6110插入序列和3个SenX3-RenX3基因座串联重复序列。结论我国生产用卡介菌上海株在传12代以内,其分子遗传学特性是稳定的。

Genetic Stability during Subculture of BCG for Vaccine Production in China

Objective To study the stability of molecular genetic characters during subculture of BCG China strain for vaccine production in China. Methods The region of deletion(RD), copy numbers of IS6110 and variable number tandem repeat sequences (VNTRs)at SenX3-RenX3 locus in working seeds and various passages of BCG China strain were tested by multiplex PCR. Results Both RD1 and RD2 were deleted in working seeds and passages 6, 9 and 12 of BCG China strain, while RD8, RD14, RD16, nRD18 and RDDenmark / Glaxo were undeleted. The working seeds and various passages of BCG China strain contained one IS6110 and 3 VNTRs at SenX3-RenX3 locus. Conclusion The molecular genetic characters of BCG China strain was stable within 12 passages.