单采原料血浆及血站分离血浆传播输血相关病原体风险的研究

发布时间：2018-03-05 08:28

本文选题：分离血浆　切入点：单采原料血浆　出处：《安徽医科大学》2015年硕士论文　论文类型：学位论文

【摘要】：研究背景:随着临床用血管理的不断规范,血液成分应用的逐步普及,临床用血浆开始出现富余,部分地区已开始出现过期报废的现象,并呈逐步增加的趋势。而另一方面,由于我国血液制品生产的原料血浆来源不足,临床白蛋白、静注丙球等血液制品供不应求。因此,探讨临床用血浆用于血液制品生产的可行性有着重要的实用价值。目前,我国尚无血站分离血浆用于血液制品生产风险评估的相关研究数据。因此,开展经输血传播输血相关病原体在单采原料血浆和血站分离血浆中的风险评估,对血站分离血浆用于血液制品生产工作的可行性分析及保证血液制品的安全性具有重要意义。目的:评估单采原血浆和血站分离血浆中常规筛查病原体的残余风险和未常规筛查病原体的风险,并采用统计学方法比较和分析两种不同来源血浆传播输血相关病原体的风险,为分离血浆用于血液制品的生产提供数据支持。材料和方法:收集2013年1月1日至2013年12月31日期间四川地区九家合作血站/血液中心和蓉生药业及其所属浆站所有HBs Ag,HCV抗体和HIV抗体初筛反应性的样本及样本信息,同时搜集同期所有献血者和献浆员的筛查信息;对于HBs Ag,HCV抗体和HIV抗体初筛反应性样本分别用中和试验,重组免疫印迹试验和蛋白印迹试验进行确证;并用改良的发病率-窗口期模型计算这两种血浆中常规筛查病原体经输血传播的残余风险;从初筛合格的样本中各随机抽取5000份左右样本及捐献者信息;分别用商用试剂盒检测HEV RNA,HCMV DNA,WNV RNA,SFTSV RNA,HAV RNA和B19 DNA,并计算样本阳性率,并用卡方检验进行比较分析;分别运用泊松分布模型法和等效检验法对单采原料血浆和血站分离血浆中这两类经输血传播病毒的残余风险进行分析比较。结果:1.2013年1月1日-2013年12月31日研究期间首次献浆员为8200名,重复献浆数为467388人次,重复献浆员所献血浆中经ELISA筛查并确证HBs Ag、抗-HCV、抗-HIV阳性数分别为11、2和3例。重复献浆员中HBV、HCV和HIV的残余风险分别为4.73/100,000、3.18/100,000和1.59/100,000;首次献浆员中HBV、HCV和HIV的残余风险分别为618.29/100,000、0.97/100,000和126.47/100,000;经计算HBV、HCV和HIV的总体残余风险分别为73.78/100,000、2.81/100,000和1.08/100,000。2.2013年1月1日-2013年12月31日研究期间献血者样本106210例,其中重复献血者为43759例,首次献血者为62451例。有重复献血者所献血液经ELISA筛查并确证HBs Ag、抗-HCV、抗-HIV阳性数分别为10例、4例和3例。重复献血者中HBV、HCV和HIV的残余风险分别为2.18/100,000、0.97/100,000和0.24/100,000;首次献血者中HBV、HCV和HIV的残余风险分别为6.08/100,000、3.59/100,000和1.05/100,000;HBV、HCV和HIV总的残余风险分别为73.88/100,000、2.53/100,000和0.72/100,000。献血者血浆放置一年后,HBV残余风险为0.0590/100,000。3.对于未常规的病原体核酸检测后,结果发现血站分离血浆样本中有一份为B19DNA阳性,一份CMV Ig M阳性,一份HEV Ig M,核酸检测阳性率为1.99/万,血清学检测阳性率为3.98/万,总体阳性率为5.96/万;单采原料血浆样本中有2份为B19 DNA阳性,2份为HAV Ig M阳性,2份为HEV Ig M阳性,核酸检测阳性率为3.97/万,血清学检测阳性率为7.94/万,总体阳性率为11.90/万。4.分别用泊松分布模型法和等效检验两种统计学方法对这两种血浆中HBV、HCV和HIV的残余风险进行统计学分析,结果均无统计学差异。对两种血浆中HAV、B19、WNV、SFTSV、HCMV、HEV的阳性率进行统计学分析,结果均无统计学差异。结论:本研究表明单采原料血浆和血站分离血浆中常规筛查病原体残余风险无统计学差异,未常规筛查病原体的总体阳性率也无统计学差异。故认为血站分离血浆传播经血传播病原体的风险并不高于单采血浆,血站分离血浆可以用于血液制品生产的需要。血站分离血浆放置一年后,传播输血相关病原体的风险低于单采血浆,建议血站分离血浆放置一年后,用于血液制品的生产。
[Abstract]:Background: with the clinical use of blood management continue to regulate the gradual popularization of blood components, the clinical use of plasma began to appear in some areas of surplus, has begun to appear overdue phenomenon, and was gradually increased. On the other hand, because the raw plasma source in our blood products production lack clinical albumin. Intravenous immunoglobulin and other blood products in short supply. Therefore, to explore the clinical feasibility of plasma for blood products has important practical value. At present, the relevant research data in China there is no blood plasma separation for blood products production risk assessment. Therefore, to carry out transfusion transmitted transfusion related pathogens in the apheresis plasma and risk assessment of raw materials the blood plasma separation, separation of the blood plasma for feasibility analysis of blood products production work and ensure the safety of blood products has important significance. The residual risk: risk assessment of apheresis plasma and blood routine screening of primary pathogens in plasma separation and routine screening of pathogens, and use statistical methods to compare and analyze the risk of two different sources of plasma transfusion related pathogens spread, provide data support for the production of blood products used for plasma separation. Materials and methods: collected during January 1, 2013 until December 31, 2013 nine / Sichuan province blood center blood bank cooperation and ronsen pharmaceuticals and their plasma station all HBs Ag, HCV antibody and HIV antibody reactivity of the sample and the sample information, we collected over the same period all blood donors and plasma donation staff screening information; for HBs Ag, HCV antibody and HIV antibody screening the reaction samples respectively by neutralization test, recombinant immunoblot assay and Western blot assay were confirmed; and with improved incidence - window model calculating the two kinds of Blood routine screening of pathogens by the residual risk of transfusion transmitted; from the screening were randomly selected each qualified sample of about 5000 copies of the sample and the donor information; using HEV RNA, detection of commercial kit HCMV DNA, WNV RNA, SFTSV RNA, HAV RNA and B19 DNA, and calculated the positive rate of the sample, and using the chi square test analysis; using Poisson distribution model and the equivalent test method of the two category of apheresis residual risk of transfusion transmitted virus in plasma and blood plasma separation in the raw materials of comparative analysis respectively. Results: 1.2013 years December 31st -2013 in January 1st for the first time during the plasma donation of 8200 employees, repeated plasma donation number for 467388 people. Repeat the plasma donation staff offered in plasma by ELISA screening and confirmation of HBs Ag, anti -HCV, anti -HIV positive numbers were 11,2 and 3 cases. Plasma donation staff in HBV, HCV and HIV of the residual risk were 4.73/100000,3.18 and 1.59 /100000 /100000; the first plasma donation staff in HBV, HCV and HIV of the residual risk were 618.29/100000,0.97/100000 and 126.47/100000; the calculation of HBV, HCV and HIV overall residual risk were -2013 in December 31st of January 1st 73.78/100000,2.81/100000 and 1.08/100000.2.2013 during the period of blood donor samples in 106210 cases, including 43759 cases of repeat blood donors for blood donors was 62451, for the first time cases. Repeat donors donated blood by ELISA screening and confirmation of HBs Ag, anti -HCV, anti -HIV positive were 10 cases, 4 cases and 3 cases. Repeat blood donors, HBV, HCV and HIV of the residual risk respectively for 2.18/100000,0.97/100000 and 0.24/100000 for the first time; blood donors, HBV, HCV and residual risk HIV were 6.08/100000,3.59/100000 and 1.05/100000; HBV, HCV and HIV of the total residual risk were 73.88/100000,2.53/100000 and 0.72/100000. blood donors for one year After HBV, the residual risk is 0.0590/100000.3. for pathogen nucleic acid detection routine not found after separation of blood plasma samples with a positive for B19DNA, a CMV Ig M a HEV Ig M positive, the positive rate of nucleic acid detection of 1.99/ million, the positive rate of serological detection of 3.98/ million, the total positive rate was 5.96/ 000; apheresis plasma samples of raw materials 2 samples were B19 DNA positive, 2 were HAV Ig M positive, 2 were HEV Ig M positive, the positive rate of nucleic acid detection of 3.97/ million, the positive rate of serological detection of 7.94/ million, the total positive rate was 11.90/ million.4. respectively with Poisson distribution model and the equivalent test two statistical methods for the two levels of HBV, HCV and HIV of the residual risk statistical analysis, the results were not statistically significant. The two levels of HAV, B19, WNV, SFTSV, HCMV, statistical analysis of the positive rate of HEV, the results were not statistically significant conclusion. This study shows that the residual risk of apheresis plasma and blood routine screening of pathogens in raw materials for plasma separation had no statistical difference, there was no statistically significant difference in the total positive rate of non routine screening of pathogens. So that the risk of blood plasma separation transmission of bloodborne pathogens is not higher than the single plasma, blood plasma separation can be used to the production of blood products. Blood separation of plasma placed after a year, the risk of transfusion transmitted pathogens is lower than that of single plasma, blood plasma separation that placed a year later, for the production of blood products.

【学位授予单位】：安徽医科大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R457.1

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