Emerg Infect Dis. 2018 Apr;24(4):691-9. doi: 10.3201/eid2404.171646.
The revelation in May 2015 of the shipment of γ irradiation-inactivated wild-type Bacillus anthracis spore preparations containing a small number of live spores raised concern about the safety and security of these materials. The finding also raised doubts about the validity of the protocols and procedures used to prepare them. Such inactivated reference materials were used as positive controls in assays to detect suspected B. anthracis in samples because live agent cannot be shipped for use in field settings, in improvement of currently deployed detection methods or development of new methods, or for quality assurance and training activities. Hence, risk-mitigated B. anthracis strains are needed to fulfill these requirements. We constructed a genetically inactivated or attenuated strain containing relevant molecular assay targets and tested to compare assay performance using this strain to the historical data obtained using irradiation-inactivated virulent spores.
2015 年 5 月，一批经过γ射线辐照失活的含有少量活孢子的野生型炭疽芽孢制备物被运出，这引发了人们对这些材料的安全性和安保问题的关注。这一发现也对制备这些材料所使用的方案和程序的有效性提出了质疑。在检测疑似炭疽芽孢的样本的检测中，这些经辐照失活的参考材料被用作阳性对照，因为在实地环境中无法使用活的制剂，也无法用于改进当前部署的检测方法或开发新方法，或用于质量保证和培训活动。因此，需要风险缓解的炭疽芽孢杆菌菌株来满足这些要求。我们构建了一个遗传失活或减毒的菌株，其中包含相关的分子检测靶点，并进行了测试，以比较使用该菌株进行检测的性能与使用辐照失活的毒力孢子获得的历史数据。
