Spindler-Raffel E, Benjamin R J, McDonald C P, Ramirez-Arcos S, Aplin K, Bekeredjian-Ding I, de Korte D, Gabriel C, Gathof B, Hanschmann K-M, Hourfar K, Ingram C, Jacobs M R, Keil S D, Kou Y, Lambrecht B, Marcelis J, Mukhtar Z, Nagumo H, Niekerk T, Rojo J, Marschner S, Satake M, Seltsam A, Seifried E, Sharafat S, Störmer M, Süßner S, Wagner S J, Yomtovian R
Paul-Ehrlich-Institut, Langen, Germany.
Cerus Corporation, Concord, CA, USA.
Vox Sang. 2017 Nov;112(8):713-722. doi: 10.1111/vox.12548. Epub 2017 Sep 27.
Interventions to prevent and detect bacterial contamination of platelet concentrates (PCs) have reduced, but not eliminated the sepsis risk. Standardized bacterial strains are needed to validate detection and pathogen reduction technologies in PCs. Following the establishment of the First International Reference Repository of Platelet Transfusion-Relevant Bacterial Reference Strains (the 'repository'), the World Health Organization (WHO) Expert Committee on Biological Standardisation (ECBS) endorsed further repository expansion.
Sixteen bacterial strains, including the four repository strains, were distributed from the Paul-Ehrlich-Institut (PEI) to 14 laboratories in 10 countries for enumeration, identification and growth measurement on days 2, 4 and 7 after low spiking levels [10-25 colony-forming units (CFU)/PC bag]. Spore-forming (Bacillus cereusPEI-B-P-07-S, Bacillus thuringiensisPEI-B-P-57-S), Gram-negative (Enterobacter cloacaePEI-B-P-43, Morganella morganiiPEI-B-P-74, PEI-B-P-91, Proteus mirabilisPEI-B-P-55, Pseudomonas fluorescensPEI-B-P-77, Salmonella choleraesuisPEI-B-P-78, Serratia marcescensPEI-B-P-56) and Gram-positive (Staphylococcus aureusPEI-B-P-63, Streptococcus dysgalactiaePEI-B-P-71, Streptococcus bovisPEI-B-P-61) strains were evaluated.
Bacterial viability was conserved after transport to the participating laboratories with one exception (M. morganiiPEI-B-P-74). All other strains showed moderate-to-excellent growth. Bacillus cereus, B. thuringiensis, E. coli, K. pneumoniae, P. fluorescens, S. marcescens, S. aureus and S. dysgalactiae grew to >10 CFU/ml by day 2. Enterobacter cloacae, P. mirabilis, S. epidermidis, S. bovis and S. pyogenes achieved >10 CFU/ml at day 4. Growth of S. choleraesuis was lower and highly variable.
The WHO ECBS approved all bacterial strains (except M. morganiiPEI-B-P-74 and S. choleraesuisPEI-B-P-78) for repository enlargement. The strains were stable, suitable for spiking with low CFU numbers, and proliferation was independent of the PC donor.
预防和检测血小板浓缩物（PC）细菌污染的干预措施虽已减少但并未消除败血症风险。需要标准化细菌菌株来验证PC中的检测和病原体灭活技术。在建立了首个血小板输血相关细菌参考菌株国际参考库（“参考库”）之后，世界卫生组织（WHO）生物标准化专家委员会（ECBS）批准进一步扩大该参考库。
包括4种参考库菌株在内的16种细菌菌株从保罗·埃利希研究所（PEI）分发至10个国家的14个实验室，用于在低加样水平[10 - 25个菌落形成单位（CFU）/PC袋]后的第2、4和7天进行计数、鉴定和生长测量。对形成芽孢的菌株（蜡样芽孢杆菌PEI - B - P - 07 - S、苏云金芽孢杆菌PEI - B - P - 57 - S）、革兰氏阴性菌（阴沟肠杆菌PEI - B - P - 43、摩根氏摩根菌PEI - B - P - 74、PEI - B - P - 91、奇异变形杆菌PEI - B - P - 55、荧光假单胞菌PEI - B - P - 77、猪霍乱沙门氏菌PEI - B - P - 78、粘质沙雷氏菌PEI - B - P - 56）和革兰氏阳性菌（金黄色葡萄球菌PEI - B - P - 63、停乳链球菌PEI - B - P - 71、牛链球菌PEI - B - P - 61）进行了评估。
运输至参与实验室后，除一种菌株（摩根氏摩根菌PEI - B - P - 74）外，其他细菌的活力均得以保持。所有其他菌株均呈现中度至良好的生长情况。蜡样芽孢杆菌、苏云金芽孢杆菌、大肠杆菌、肺炎克雷伯菌、荧光假单胞菌、粘质沙雷氏菌、金黄色葡萄球菌和停乳链球菌在第2天时生长至>10 CFU/ml。阴沟肠杆菌、奇异变形杆菌、表皮葡萄球菌、牛链球菌和化脓性链球菌在第4天时达到>10 CFU/ml。猪霍乱沙门氏菌的生长较低且高度可变。
WHO ECBS批准所有细菌菌株（摩根氏摩根菌PEI - B - P - 74和猪霍乱沙门氏菌PEI - B - P - 78除外）用于扩大参考库。这些菌株稳定，适合低CFU数量加样，且增殖与PC供体无关。
