Chunhui Yang, Guohui Bian, Hong Yang, Xiaopu Xiao, Zherong Bai, Mingyuan Wang, Xinsheng Zhang, Juanjuan Wang, Changqing Li, Wuping Li
Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, China.
Transfus Apher Sci. 2013 Dec;49(3):631-9. doi: 10.1016/j.transci.2013.07.008. Epub 2013 Aug 5.
Pathogen reduction technology is an important process in the blood safety system, including solvent/detergent treatment, filtration and methylene blue-photochemical technology (MB-PCT). To investigate the quality of MB-PCT-treated plasma, plasma samples from four Chinese blood centers were analyzed over 12 months of storage to determine the recovery of activities and levels of various plasma proteins.
Ten plasma units each from the Suzhou, Yancheng, Chongqing and Shandong blood centers were divided into two aliquots. One was subjected to treatment with one of two methylene blue-photochemical technology instruments and the other was used as control. The treated and untreated sample pairs were stored at -30°C. The recovery rates of coagulation factors, inhibitor proteins, total protein, immunoglobulins, and complement proteins were measured at different time points after storage.
The mean recovery of most proteins exceeded 80% after MB treatment. The exceptions were factor XI and fibrinogen, of which only 71.3-74% and 69.0-92.3% were retained during storage. The two equipment types differed in terms of residual MB concentration in the plasma samples (0.18 μM and 0.29 μM, respectively). They had similar protein recovery rates at 0.5 month but differed at later time points. The four blood centers differed significantly with regard to factor II, V, VIII and fibrinogen activities. Only the samples from the Shandong blood center met the methylene blue treated fresh frozen plasma requirement. The major factor that influenced the quality of the MB-FFP samples was the time taken between blood collection and storage.
Methylene blue treated plasma showed reduced coagulation factor (CF) activity and protein levels. The MB treatment-induced damage to the proteins was acceptable at the four Chinese blood centers, but the quality of the MB-treated plasma in general was not satisfactory. The main factor affecting plasma quality may be the duration of the collection and processing.
病原体灭活技术是血液安全系统中的一个重要环节，包括溶剂/去污剂处理、过滤和亚甲蓝光化学技术（MB-PCT）。为了研究经MB-PCT处理的血浆质量，对来自四个中国血液中心的血浆样本进行了为期12个月的储存分析，以确定各种血浆蛋白的活性回收率和水平。
分别从苏州、盐城、重庆和山东血液中心采集10个血浆单位，每个血浆单位分成两份。一份用两种亚甲蓝光化学技术仪器之一进行处理，另一份作为对照。处理后的样本与未处理的样本对储存在-30°C。在储存后的不同时间点测量凝血因子、抑制蛋白、总蛋白、免疫球蛋白和补体蛋白的回收率。
MB处理后，大多数蛋白质的平均回收率超过80%。例外的是因子XI和纤维蛋白原，在储存期间仅保留了71.3-74%和69.0-92.3%。两种设备类型的血浆样本中亚甲蓝残留浓度不同（分别为0.18μM和0.29μM）。它们在0.5个月时的蛋白质回收率相似，但在随后的时间点有所不同。四个血液中心在因子II、V、VIII和纤维蛋白原活性方面存在显著差异。只有来自山东血液中心的样本符合亚甲蓝处理的新鲜冰冻血浆要求。影响MB-FFP样本质量的主要因素是采血与储存之间的时间间隔。
亚甲蓝处理的血浆显示凝血因子（CF）活性和蛋白质水平降低。在中国的四个血液中心，MB处理对蛋白质造成的损害是可以接受的，但总体而言，MB处理的血浆质量并不令人满意。影响血浆质量的主要因素可能是采集和处理的持续时间。
