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威尔士血液服务中心对血小板进行细菌污染筛查。

Screening of platelets for bacterial contamination at the Welsh Blood Service.

作者信息

Pearce S, Rowe G P, Field S P

机构信息

Welsh Blood Service, Laboratory Services, Pontyclun, UK.

出版信息

Transfus Med. 2011 Feb;21(1):25-32. doi: 10.1111/j.1365-3148.2010.01037.x. Epub 2010 Sep 21.

Abstract

BACKGROUND AND OBJECTIVE

This report details the results of the implementation of a bacterial screening system at the Welsh Blood Service and provides an estimate of the levels of bacterial contamination at the time of sampling.

MATERIALS AND METHODS

Apheresis (Caridian BCT) and buffy coat-derived pooled platelet components were sampled on day 1 for bacterial contamination and the sample was monitored throughout the lifespan of the platelet component. Unused platelet components were re-tested to determine the effectiveness of the screening. Results from the BacT/ALERT are uploaded to the in-house Blood Establishment Computer System (BECS) every 12 min. Positive alerts are automatically sent to staff, facilitating a timely intervention.

RESULTS

Between February 2003 and March 2010 the screening system tested 54 828 platelets and detected 257 (1 in 213) initial positives of which 35 (1 in 1567, 0·06%) were confirmed [95% confidence interval (CI), 0·04-0·08%]. Additionally, screening of 6438 unused platelet components detected another 6 (1 in 1073, 0·09%) confirmed positives not detected during initial testing (95% CI, 0·02-0·16%). Analysis of the data suggests that on day 1 the number of bacteria in such platelet component packs was between 5 and 62 cfus total. Day 1 culture has a sensitivity of 40%.

CONCLUSIONS

The bacterial screening system has removed a significant number, but not all bacterially contaminated platelet components from the supply. The sample volume is an important factor in sensitivity due to the low number of bacteria in a platelet component pack on day 1. An effective notification and recall system is a critical part of the bacterial screening system.

摘要

背景与目的

本报告详细介绍了威尔士血液服务机构实施细菌筛查系统的结果,并对采样时的细菌污染水平进行了估计。

材料与方法

在第1天对单采(Caridian BCT)和来源于 Buffy 层的混合血小板成分进行细菌污染采样,并在血小板成分的整个保存期内对样本进行监测。对未使用的血小板成分进行重新检测,以确定筛查的有效性。BacT/ALERT 的结果每12分钟上传至内部血液机构计算机系统(BECS)。阳性警报会自动发送给工作人员,以便及时进行干预。

结果

在2003年2月至2010年3月期间,筛查系统检测了54828个血小板,检测出257个(213个中有1个)初始阳性,其中35个(1567个中有1个,0.06%)得到确认[95%置信区间(CI),0.04 - 0.08%]。此外,对6438个未使用的血小板成分进行筛查,又检测出6个(1073个中有1个,0.09%)在初始检测时未检测到的确认阳性(95% CI,0.02 - 0.16%)。数据分析表明,在第1天,此类血小板成分包装中的细菌总数在5至62 cfu之间。第1天培养的灵敏度为40%。

结论

细菌筛查系统已从供应中去除了大量但并非所有受细菌污染的血小板成分。由于第1天血小板成分包装中的细菌数量较少,样本量是影响灵敏度的一个重要因素。有效的通知和召回系统是细菌筛查系统的关键部分。

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