Benjamin Richard J, Kline Linda, Dy Beth A, Kennedy Jean, Pisciotto Patricia, Sapatnekar Suneeti, Mercado Rachel, Eder Anne F
National Headquarters, American Red Cross, Washington, DC 20006, USA.
Transfusion. 2008 Nov;48(11):2348-55. doi: 10.1111/j.1537-2995.2008.01853.x. Epub 2008 Jul 22.
Bacterial sepsis following whole blood-derived platelet (WBP) transfusion has remained a substantial patient risk, primarily due to a lack of practical and effective means to limit or detect bacterial contamination. We describe the risk of reported septic reactions to WBPs and the introduction of prestorage-pooled whole blood-derived platelets (PSPs) collected using initial sample diversion and cultured for bacterial contamination.
Product qualification and quality control (QC) testing with the Acrodose PL system (Pall Medical) were evaluated in four regional blood centers. Bacterial contamination risk was assessed by review of reported septic transfusion reactions to WBPs and by aerobic QC culture of leukoreduced PSPs utilizing automated microbial detection system cultures (BacT/ALERT 3D, bioMérieux).
Before implementing PSPs (January 2003-December 2006), we distributed 2,535,043 WBP units and received 20 reports of septic reactions including 2 fatalities (7.9 per million [1:126,752] reactions and 0.79 per million [1:1,267,522] fatalities). In October 2006, PSPs were effectively implemented with a product qualification success rate of 99.6 percent and a mean yield of 4.0 x 10(11) platelets (PLTs) per pool. Whole blood collection sets with sample diversion technology were introduced during the operational trial and decreased the rate of confirmed-positive bacterial culture of PSPs from 2111 (1:474) to 965 (1:1036) per million (odds ratio, 0.46; 95% confidence interval, 0.22-0.95). No septic reactions to PSPs were reported (25,936 PSP units distributed).
Sample diversion and bacterial culture are effective methods to reduce bacterial risk with WBP transfusion. Bacterial contamination of PSPs was assessed at 5.8-fold our current rate for apheresis PLTs utilizing comparable culture protocols.
全血来源血小板（WBP）输注后的细菌败血症仍然是患者面临的重大风险，主要原因是缺乏限制或检测细菌污染的实用有效方法。我们描述了报告的对WBP的败血症反应风险，以及采用初始样本分流收集并进行细菌污染培养的预储存混合全血来源血小板（PSP）的引入情况。
在四个地区血液中心评估了使用Acrodose PL系统（颇尔医疗）进行的产品鉴定和质量控制（QC）检测。通过回顾报告的对WBP的败血症输血反应以及利用自动微生物检测系统培养（BacT/ALERT 3D，生物梅里埃公司）对白细胞去除的PSP进行需氧QC培养来评估细菌污染风险。
在实施PSP之前（2003年1月至2006年12月），我们分发了2,535,043个WBP单位，并收到20例败血症反应报告，包括2例死亡（每百万单位有7.9例反应[1:126,752]，每百万单位有0.79例死亡[1:1,267,522]）。2006年10月，PSP得以有效实施，产品鉴定成功率为99.6%，每个混合池的血小板（PLT）平均产量为4.0×10¹¹。在操作试验期间引入了带有样本分流技术的全血采集装置，使PSP的确认阳性细菌培养率从每百万单位2111例（1:474）降至965例（1:1036）（优势比，0.46；95%置信区间，0.22 - 0.95）。未报告对PSP的败血症反应（分发了25,936个PSP单位）。
样本分流和细菌培养是降低WBP输血细菌风险的有效方法。利用可比培养方案评估，PSP的细菌污染率是我们目前单采血小板污染率的5.8倍。
