Abstract：
OBJECTIVE: Blood safety measures used by blood establishments to increase blood component safety can be validated using Transfusion-Relevant Bacterial Reference Strains (TRBRS). Ultra-cold storage conditions and manual preparation of the current TRBRS may restrict their practical use. To address this issue, the ISBT Transfusion-Transmitted Infectious Diseases Working Party\'s Bacterial Subgroup organized an international study to validate TRBRS in a user-friendly, lyophilised format.
METHODS: Two bacterial strains Klebsiella pneumoniae PEI-B-P-08 and Staphylococcus aureus PEI-B-P-63 were manufactured as lyophilised material. The lyophilised bacteria were distributed to 11 different labs worldwide to assess the robustness for enumeration, identification and determination of growth kinetics in platelet concentrates (PCs).
RESULTS: Production of lyophilised TRBRS had no impact on the growth properties compared with the traditional format. The new format allows a direct low-quantity spiking of approximately 30 bacteria in PCs for transfusion-relevant experiments. In addition, the lyophilised bacteria exhibit long-term stability across a broad temperature range and can even be directly rehydrated in PCs without losing viability. Interlaboratory comparative study demonstrated the robustness of the new format as 100% of spiked PC exhibited growth.
CONCLUSIONS: Lyophilised TRBRS provide a user-friendly material for transfusion-related studies. TRBRS in the new format have improved features that may lead to a more frequent use in the quality control of transfusion-related safety measures in the future.
METHODS: Two bacterial strains Klebsiella pneumoniae PEI-B-P-08 and Staphylococcus aureus PEI-B-P-63 were manufactured as lyophilised material. The lyophilised bacteria were distributed to 11 different labs worldwide to assess the robustness for enumeration, identification and determination of growth kinetics in platelet concentrates (PCs).
RESULTS: Production of lyophilised TRBRS had no impact on the growth properties compared with the traditional format. The new format allows a direct low-quantity spiking of approximately 30 bacteria in PCs for transfusion-relevant experiments. In addition, the lyophilised bacteria exhibit long-term stability across a broad temperature range and can even be directly rehydrated in PCs without losing viability. Interlaboratory comparative study demonstrated the robustness of the new format as 100% of spiked PC exhibited growth.
CONCLUSIONS: Lyophilised TRBRS provide a user-friendly material for transfusion-related studies. TRBRS in the new format have improved features that may lead to a more frequent use in the quality control of transfusion-related safety measures in the future.
摘要：
目的：可以使用输血相关细菌参考菌株（TRBRS）来验证血液机构用于提高血液成分安全性的血液安全措施。当前TRBRS的超冷储存条件和手动制备可能会限制其实际使用。为了解决这个问题，ISBT输血传播的传染病工作组的细菌亚组组织了一项国际研究，以用户友好的方式验证TRBRS，冻干形式。
方法:制备两种细菌菌株肺炎克雷伯菌PEI-B-P-08和金黄色葡萄球菌PEI-B-P-63作为冻干材料。冻干细菌被分配到全球11个不同的实验室，以评估计数的稳健性，血小板浓缩物（PC）中生长动力学的鉴定和测定。
结果：与传统形式相比，冻干TRBRS的生产对生长特性没有影响。新格式允许在PC中直接少量掺入约30个细菌，用于输血相关实验。此外,冻干细菌在宽的温度范围内表现出长期稳定性,并且甚至可以在PC中直接再水化而不丧失生存力。实验室间比较研究证明了新格式的稳健性，因为100％的加标PC表现出增长。
结论：冻干TRBRS为输血相关研究提供了一种用户友好的材料。新格式的TRBRS具有改进的功能，可能会导致将来在输血相关安全措施的质量控制中更频繁地使用。
方法:制备两种细菌菌株肺炎克雷伯菌PEI-B-P-08和金黄色葡萄球菌PEI-B-P-63作为冻干材料。冻干细菌被分配到全球11个不同的实验室，以评估计数的稳健性，血小板浓缩物（PC）中生长动力学的鉴定和测定。
结果：与传统形式相比，冻干TRBRS的生产对生长特性没有影响。新格式允许在PC中直接少量掺入约30个细菌，用于输血相关实验。此外,冻干细菌在宽的温度范围内表现出长期稳定性,并且甚至可以在PC中直接再水化而不丧失生存力。实验室间比较研究证明了新格式的稳健性，因为100％的加标PC表现出增长。
结论：冻干TRBRS为输血相关研究提供了一种用户友好的材料。新格式的TRBRS具有改进的功能，可能会导致将来在输血相关安全措施的质量控制中更频繁地使用。
