Raw Data for the article: Use of 27G needles improves sensitivity and performance of ATCC anaerobe reference microorganism detection in BacT/Alert system

Effective detection of microbiological contaminations present in medicinal cellular products is a crucial step to ensure patients' safety. In recent decades, several rapid microbiological methods have been developed and validated, but variabilities linked to the use of different resources have led to discordant validation of methods and performance results. Considering this, while developing an in-house BacT/Alert-based method, we evaluated all of the materials used in its validation. Of particular importance, we noticed that the syringe gauge used to inject the samples into the bottles was crucial to obtain robust results. We chose to conduct a comparative test between the BacT/Alert system and the compendial method described in the European Pharmacopoeia, using five dilutions of nine reference microorganism strains and 21G or 27G needles. Our results confirmed that the BacT/Alert system is a valid and faster alternative method to assess sterility of clinical cell therapy products, and that the use of 27G needles increases its sensitivity to detect reference anaerobe microorganisms.有效检测药用细胞制品中的微生物污染，是保障患者安全的核心环节。近数十年来，多种快速微生物检测方法已被开发并完成验证，但因使用不同实验资源带来的方法变异性，导致各方法的验证结果与性能表现存在不一致。鉴于此，在开发基于BacT/Alert的实验室内部检测方法时，我们对该方法验证过程中使用的全部耗材开展了评估。尤为关键的是，我们发现用于向培养瓶中注入样品的注射器针头规格（syringe gauge），对获取稳定可靠的检测结果至关重要。本研究采用9株标准微生物菌株的5种稀释液，分别搭配21G与27G针头，开展了BacT/Alert系统与欧洲药典收载的法定检测方法的对比测试。结果证实，BacT/Alert系统是评估临床细胞治疗制品无菌性的有效且更快速的替代检测方法；同时使用27G针头可提升该系统对标准厌氧微生物的检测灵敏度。