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血浆库中丙型肝炎病毒的流行率及冷乙醇分级分离的效果

Prevalence of hepatitis C virus in plasma pools and the effectiveness of cold ethanol fractionation.

作者信息

Scheiblauer H, Nübling M, Willkommen H, Löwer J

机构信息

Paul-Ehrlich-Institut, Langen, Germany.

出版信息

Clin Ther. 1996;18 Suppl B:59-70. doi: 10.1016/s0149-2918(96)80196-2.

DOI:10.1016/s0149-2918(96)80196-2
PMID:8930442
Abstract

Screening blood donations for antibodies against hepatitis C virus (HCV) greatly reduces the risk of transmitting HCV by transfusions. However, despite such screening programs, plasma pools still contain a high percentage of HCV ribonucleic acid as determined by polymerase chain reaction. This result would not be alarming if the procedures for producing blood products included steps to inactivate or remove HCV. Although this appeared to be the case for all blood products, such as coagulation factors and most immunoglobulins, which are subjected to an inactivation step, the effectiveness of the cold ethanol fractionation process still needed to be determined. In validation experiments using bovine viral diarrhea virus as a model virus for HCV, we demonstrated that the Cohn-Oncley cold ethanol fractionation process neither inactivated nor removed this virus sufficiently. Our observations may help to explain how HCV was transmitted to a number of recipients of intravenous immunoglobulin.

摘要

筛查献血者是否存在丙型肝炎病毒(HCV)抗体可大大降低输血传播HCV的风险。然而,尽管有此类筛查项目,但通过聚合酶链反应测定发现,血浆库中仍含有高比例的HCV核糖核酸。如果血液制品的生产程序包含灭活或去除HCV的步骤,这一结果就不会令人担忧。尽管对于所有血液制品,如凝血因子和大多数免疫球蛋白,似乎都是这种情况,它们都经过了灭活步骤,但冷乙醇分级分离过程的有效性仍有待确定。在使用牛病毒性腹泻病毒作为HCV模型病毒的验证实验中,我们证明Cohn-Oncley冷乙醇分级分离过程既不能充分灭活也不能充分去除这种病毒。我们的观察结果可能有助于解释HCV是如何传播给一些静脉注射免疫球蛋白接受者的。

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Prevalence of hepatitis C virus in plasma pools and the effectiveness of cold ethanol fractionation.血浆库中丙型肝炎病毒的流行率及冷乙醇分级分离的效果
Clin Ther. 1996;18 Suppl B:59-70. doi: 10.1016/s0149-2918(96)80196-2.
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A sensitive PCR method for detecting HCV RNA in plasma pools, blood products, and single donations.一种用于检测血浆池、血液制品和单份献血中丙型肝炎病毒RNA的灵敏聚合酶链反应方法。
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Virus reduction in the preparation of intravenous immune globulin: in vitro experiments.静脉注射免疫球蛋白制备过程中的病毒去除:体外实验
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Introduction of the gene amplification technique to decrease the risk of hepatitis C virus transmission by plasma products.引入基因扩增技术以降低血浆制品传播丙型肝炎病毒的风险。
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Including polymerase chain reaction in screening for hepatitis C virus RNA in blood donations is not cost-effective.在献血筛查中纳入丙型肝炎病毒RNA的聚合酶链反应检测并不具有成本效益。
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The viral safety of intravenous immune globulin.静脉注射免疫球蛋白的病毒安全性。
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引用本文的文献

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Manufacture of immunoglobulin products for patients with primary antibody deficiencies - the effect of processing conditions on product safety and efficacy.用于原发性抗体缺陷患者的免疫球蛋白产品的生产——加工条件对产品安全性和有效性的影响。
Front Immunol. 2014 Dec 23;5:665. doi: 10.3389/fimmu.2014.00665. eCollection 2014.
2
Ensuring the biologic safety of plasma-derived therapeutic proteins: detection, inactivation, and removal of pathogens.确保血浆源性治疗性蛋白质的生物安全性:病原体的检测、灭活和去除。
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