Department of Pathology and ARUP Laboratories, University of Utah, Salt Lake City, Utah, USA.
Transfusion. 2020 Aug;60(8):1723-1731. doi: 10.1111/trf.15919. Epub 2020 Jul 6.
Bacterial contamination of platelets is a problem that can lead to harmful septic transfusion reactions. The US Food and Drug Administration published a guidance in September 2019 detailing several permissible risk control strategies. Our objective was to compare the safety of each bacterial testing strategy for apheresis platelets.
We used simulation to compare safety of the nine risk control strategies involving apheresis platelet testing. The primary outcome was the risk of exposure. An exposure event occurred if a patient received platelets exceeding a specific contamination threshold (>0, 10 , and 10 colony-forming units (CFU/mL). We generated a range of bacterial contamination scenarios (inoculum size, doubling time, lag time) and compared risk of exposure for each policy in each contamination scenario. We then computed the average risk difference over all scenarios.
At the 0 CFU/mL exposure threshold, two-step policies that used secondary culture ranked best (all top three), while single-step 24-hour culture with 3-day expiration ranked last (ninth). This latter policy performed well (median rank of 1) at both the 10 and 10 CFU/mL thresholds, but 48-hour culture with 7-day expiration performed relatively poorly. At these higher thresholds, median ranks of two-step policies that used secondary culture were again top three. Two-step policies that used rapid testing improved at the higher (10 CFU/mL) harm threshold, with median rankings between 1 and 5.
Two-step policies that used secondary culture were generally safer than single-step policies. Performance of two-step policies that used rapid testing depended on the CFU per milliter threshold of exposure used.
血小板的细菌污染是一个可能导致有害感染性输血反应的问题。美国食品和药物管理局在 2019 年 9 月发布了一份指南，详细说明了几种可接受的风险控制策略。我们的目的是比较用于单采血小板的每种细菌检测策略的安全性。
我们使用模拟来比较涉及单采血小板检测的 9 种风险控制策略的安全性。主要结果是暴露风险。如果患者接受的血小板超过特定污染阈值（>0、10 和 10 个菌落形成单位[CFU/mL]），则发生暴露事件。我们生成了一系列细菌污染场景（接种物大小、倍增时间、滞后时间），并在每种污染场景下比较每种策略的暴露风险。然后，我们计算了所有场景的平均风险差异。
在 0 CFU/mL 的暴露阈值下，使用二级培养的两步策略排名最佳（均在前三位），而使用 3 天有效期的单步 24 小时培养排名最后（第九位）。后一种策略在 10 和 10 CFU/mL 阈值下表现良好（中位数排名 1），但 48 小时培养加 7 天有效期的表现相对较差。在这些较高的阈值下，使用二级培养的两步策略的中位数排名再次位居前三。使用快速检测的两步策略在较高（10 CFU/mL）的危害阈值下表现有所改善，中位数排名在 1 到 5 之间。
使用二级培养的两步策略通常比单步策略更安全。使用快速检测的两步策略的性能取决于使用的暴露 CFU/mL 阈值。
