Alrabeh Reem, Korte Laura, Reyes Meredith, Hartwell Elizabeth, Bracey Arthur
Department of Cardiology, CHI St. Luke's Health - Baylor St. Luke's Medical Center, Houston, TX, USA.
Department of Pathology, Baylor College of Medicine, Houston, TX, USA.
Ann Clin Lab Sci. 2019 Nov;49(6):748-755.
Bacterial sepsis after platelet transfusion is a major cause of transfusion-transmitted infections in the US. The Food and Drug Administration (FDA) recommends performing quality control for platelet bacterial detection on days 4 and 5 before platelet transfusion. We assessed the feasibility of implementing the Pan Genera Detection (PGD) test, an FDA-approved immunoassay for platelet bacterial detection, for the primary and secondary bacterial screening of platelet units in a high-volume setting. Records were reviewed from January 2010 through December 2015. All apheresis platelets underwent primary screening by using culture methods. Additional screening with the PGD test was performed daily until February 2013, when PGD testing of apheresis platelets was performed at the start of storage day 5. In April 2015, PGD testing of apheresis platelet products was performed at the start of storage day 4. Post-storage pooled whole blood-derived platelets were screened by using the PGD test on the day of use. During the 6-year study period, 16,839 PGD tests were performed. If the PGD test was reactive, repeat PGD testing was performed. In cases of repeat reactivity, units were quarantined and cultured. Initially, 42 (0.25%) tests were reactive; 26/42 (61.91%) were repeatedly reactive and resulted in an overall PGD repeat reactivity rate of 0.15%. Only one sample grew coagulase-negative No transfusion-transmitted infections were reported. The PGD bacterial detection assay was feasible and efficient in our high-volume transfusion service.
在美国，血小板输注后发生的细菌性败血症是输血传播感染的主要原因。美国食品药品监督管理局（FDA）建议在血小板输注前第4天和第5天对血小板进行细菌检测的质量控制。我们评估了实施泛属检测（PGD）试验的可行性，这是一种经FDA批准的用于血小板细菌检测的免疫测定法，用于在大容量环境下对血小板单位进行一级和二级细菌筛查。回顾了2010年1月至2015年12月的记录。所有单采血小板均采用培养方法进行一级筛查。在2013年2月之前，每天都使用PGD试验进行额外筛查，之后在储存第5天开始时对单采血小板进行PGD检测。2015年4月，在储存第4天开始时对单采血小板产品进行PGD检测。储存后的混合全血来源血小板在使用当天采用PGD试验进行筛查。在6年的研究期间，共进行了16,839次PGD检测。如果PGD试验呈阳性反应，则进行重复PGD检测。在重复阳性反应的情况下，对单位进行隔离并培养。最初，42次（0.25%）检测呈阳性反应；26/42次（61.91%）重复呈阳性反应，导致PGD重复阳性反应率总体为0.15%。只有一个样本培养出凝固酶阴性菌。未报告输血传播感染。PGD细菌检测试验在我们的大容量输血服务中是可行且有效的。
