Detection of bacteria in stored red cell products using a culture-based bacterial detection system
Detection of bacteria in stored red cell products using a culture-based bacterial detection system
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DOI：
10.1111/j.1537-2995.2008.01716.x
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发表时间：
2008-08-01
期刊：
影响因子：
2.9
通讯作者：
McDonald, Carl P.
中科院分区：
文献类型：
--
作者：
Chen, Cyndi L.;Yu, Jing-Chen;McDonald, Carl P.
背景：颇尔 eBDS 使用耗氧量作为血小板 (PLT) 产品中细菌检测的替代标记。本文描述了 eBDS 的评估，以检测接种的新鲜和储存的去白细胞 (RBC) 单位中的细菌污染。 研究设计和方法：在三个地点进行了现场研究，以确定 eBDS 袋孵育时间和通过/失败阈值。红细胞单位接种了 12 种已知可引起败血症的细菌，目标接种物的浓度为每毫升 1 至 15 或 100 个菌落形成单位 (CFU)。将单位混合并在 2 至 6 摄氏度下保存。从 0 小时到 42 天，每周采集样本进行培养和 eBDS 测试，并在 35 摄氏度下孵育 24 至 30、48 和 72 小时，然后测量氧含量百分比。 结果：研究显示，红细胞单位中有 5 种细菌（包括小肠结肠炎耶尔森氏菌）生长，而 7 种细菌没有生长或自动灭菌。根据未接种对照 (n = 633) 和孵育 48 小时后接种样品 (n = 884) 的结果确定 14.4% 的通过/失败氧阈值。在冷藏保存期间的所有采样时间，在袋孵育 48 小时和 72 小时的情况下，检测均为 100%。结论：eBDS 袋孵育 48 小时和 72 小时，884 个样品获得 100% 检测，细菌水平至少为 1 CFU/mL，并且没有获得假阳性样品。根据细菌生长模式，可在收集后 1 至 3 天对红细胞单位进行采样，以获得最佳功效，并在 eBDS 样品袋在 35 摄氏度下孵育 48 至 72 小时后进行读取。颇尔 eBDS 适合检测新鲜和储存的红细胞中的典型细菌污染物。
BACKGROUND: The Pall eBDS uses oxygen consumption as a surrogate marker for bacterial detection in platelet (PLT) products. This article describes the evaluation of eBDS to detect bacterial contamination in inoculated fresh and stored leukoreduced red cell (RBC) units.STUDY DESIGN AND METHODS: Field studies were conducted at three sites to establish eBDS pouch incubation time and the pass/fail threshold. RBC units were inoculated with each of 12 bacterial species known to cause sepsis at target inocula of either 1 to 15 or 100 colony-forming units (CFUs) per mL. Units were mixed and stored at 2 to 6 degrees C. Samples were taken for culture and eBDS testing weekly from 0 hour to 42 days and incubated for 35 degrees C for 24 to 30, 48, and 72 hours, followed by measurement of percent oxygen content.RESULTS: The studies showed growth of five bacterial species (including Yersinia enterocolitica) in RBC units, while seven bacterial species showed no growth or autosterilized. A pass/fail oxygen threshold of 14.4 percent was determined based on results from noninoculated controls (n = 633) and from inoculated samples (n = 884) after 48 hours of incubation. Detection was 100 percent at all sampling times during refrigerated storage with both 48 and 72 hours of pouch incubation.CONCLUSION: With incubation of eBDS pouches for 48 and 72 hours, 100 percent detection was obtained in 884 samples with bacterial levels of at least 1 CFU per mL, and no false-positive samples were obtained. Based on the bacterial growth patterns, RBC units may be sampled 1 to 3 days after collection for optimal efficacy and read after 48 to 72 hours of incubation of the eBDS sample pouches at 35 degrees C. The Pall eBDS is suited for detection of typical bacterial contaminants in fresh and stored RBCs.