Keil Shawn D, Bengrine Abderrahmane, Bowen Richard, Marschner Susanne, Hovenga Nick, Rouse Lindsay, Gilmour Denise, Duverlie Gilles, Goodrich Raymond P
Terumo BCT, Lakewood, Colorado.
Biobanque de Picardie, EA4294, UPJV, CHU-Amiens, Amiens, France.
Transfusion. 2015 Jul;55(7):1736-44. doi: 10.1111/trf.13030. Epub 2015 Mar 3.
Multilayered blood safety programs reduce the risk of transfusion-transmitted diseases; however, there remains a risk of window period transmission of screened viruses and transmission of unscreened and emerging viruses from asymptomatic donors. To reduce this risk, a riboflavin-and-UV-light-based pathogen reduction process was evaluated against eight viral agents.
Riboflavin and UV light was evaluated against the following eight viral agents: encephalomyocarditis virus (EMC), hepatitis A virus (HAV), hepatitis C virus (HCV), influenza A (FLUAV), La Crosse virus (LACV), pseudorabies virus (PRV), sindbis virus (SINV), and vesicular stomatitis virus (VSV). Before treatment, a sample was removed to determine the product's initial viral load. After treatment the product's viral load was reevaluated and the log reduction was calculated.
Virus reduction after treatment with riboflavin and UV light is equivalent in platelet (PLT) and plasma units, as demonstrated by a 3.2-log reduction of EMC in plasma, PLTs, and PLT additive solution containing 35% plasma. Additionally, the following viral reductions values were observed: HAV 1.8 log, HCV at least 4.1 log, FLUAV at least 5.0 log, LACV at least 3.5 log, PRV 2.5 log, SINV 3.2 log, and VSV at least 6.3 log.
The results observed in this study suggest that treating PLT and plasma products with a riboflavin-and-UV-light-based pathogen reduction process could potentially eliminate window period transmission of screened viruses and greatly reduce the risk of transfusion transmission of unscreened viruses.
多层血液安全计划可降低输血传播疾病的风险;然而,经筛查病毒的窗口期传播以及无症状献血者传播未筛查和新出现病毒的风险依然存在。为降低此风险,对一种基于核黄素和紫外线的病原体灭活工艺针对八种病毒制剂进行了评估。
针对以下八种病毒制剂评估了核黄素和紫外线:脑心肌炎病毒(EMC)、甲型肝炎病毒(HAV)、丙型肝炎病毒(HCV)、甲型流感病毒(FLUAV)、拉科罗斯病毒(LACV)、伪狂犬病病毒(PRV)、辛德毕斯病毒(SINV)和水疱性口炎病毒(VSV)。处理前,取出一份样品以确定产品的初始病毒载量。处理后,重新评估产品的病毒载量并计算对数下降值。
核黄素和紫外线处理后血小板(PLT)和血浆制品中的病毒减少情况相当,如血浆、血小板以及含35%血浆的血小板添加剂溶液中EMC的对数下降值为3.2所示。此外,还观察到以下病毒减少值:HAV为1.8对数,HCV至少为4.1对数,FLUAV至少为5.0对数,LACV至少为3.5对数,PRV为2.5对数,SINV为3.2对数,VSV至少为6.3对数。
本研究观察到的结果表明,用基于核黄素和紫外线的病原体灭活工艺处理血小板和血浆制品可能会消除经筛查病毒的窗口期传播,并大大降低未筛查病毒的输血传播风险。