Schmidt M, Karakassopoulos A, Burkhart J, Deitenbeck R, Asmus J, Müller T H, Weinauer F, Seifried E, Walther-Wenke G
German Red Cross Institute Frankfurt, Frankfurt, Germany.
Vox Sang. 2007 Jan;92(1):15-21. doi: 10.1111/j.1423-0410.2006.00850.x.
Since 2004, bacterial screening of platelets has been required in the USA and is also done on a voluntary basis in many European countries. The German Red Cross blood donor services conducted a prospective multicentre study in order to investigate the prevalence of bacterially contaminated pool platelet concentrates and apheresis platelet concentrates. This substudy compares three different bacterial detection systems.
Platelet concentrates were tested in parallel with BacT/ALERT, Scansystem and Pall eBDS (n = 6307) in pool platelets. Apheresis platelets were tested in parallel with BacT/ALERT and Pall eBDS (n = 4730). All initially positive results were evaluated by a standardized procedure including evaluation by a microbiology reference laboratory.
One in 6307 pool platelets were confirmed positive by BacT/ALERT, whereas Pall eBDS and Scansystem failed to detect these samples. Only three samples were initially reactive with Pall eBDS without proof of any bacteria strains. The rate of false-positive results was substantially higher for BacT/ALERT (0.25%, 28 in 11,037 tested samples) than for eBDS (0.03%, 3 in 11 037 tested samples) or Scansystem (0.0%, 0 in 6307 tested samples). Three of 4730 apheresis platelets were confirmed positive by BacT/ALERT. These were negative with Pall eBDS.
Sensitivity was best for BacT/ALERT, whereas specificity was enhanced for Pall eBDS and Scansystem. Scansystem required specially trained staff, whereas BacT/ALERT and Pall eBDS were easy, quick, user-friendly and objective methods.
自2004年起，美国要求对血小板进行细菌筛查，许多欧洲国家也自愿开展此项筛查。德国红十字会血液捐献服务机构进行了一项前瞻性多中心研究，以调查混合血小板浓缩物和单采血小板浓缩物中细菌污染的发生率。本亚研究比较了三种不同的细菌检测系统。
对混合血小板中的血小板浓缩物与BacT/ALERT、Scansystem和颇尔eBDS进行平行检测（n = 6307）。对单采血小板与BacT/ALERT和颇尔eBDS进行平行检测（n = 4730）。所有最初的阳性结果均通过标准化程序进行评估，包括由微生物学参考实验室进行评估。
在6307份混合血小板中，有1份经BacT/ALERT确认为阳性，而颇尔eBDS和Scansystem未能检测出这些样本。仅有3份样本最初与颇尔eBDS呈反应性，但未证实有任何细菌菌株。BacT/ALERT的假阳性率（0.25%，11037份检测样本中有28份）显著高于eBDS（0.03%，11037份检测样本中有3份）或Scansystem（0.0%，6307份检测样本中为0份）。在4730份单采血小板中，有3份经BacT/ALERT确认为阳性。这些样本用颇尔eBDS检测为阴性。
BacT/ALERT的灵敏度最佳，而颇尔eBDS和Scansystem的特异性更高。Scansystem需要经过专门培训的工作人员，而BacT/ALERT和颇尔eBDS则是简便、快速、用户友好且客观的方法。
