Dorner F, Barrett P N, Eibl J
Biomedical Research Center, Immuno AG, Orth/Donau, Austria.
Dev Biol Stand. 1993;81:137-43.
On an industrial scale blood products are produced from plasma pools consisting of donations from thousands of donors. As a number of pathogens may be present in the donor before symptoms of an infectious disease become evident, such pathogens, particularly viruses, may be transmitted in human blood products. The level of virus contamination can be substantially reduced by a range of serological tests and by polymerase chain reaction screening. Viruses can also be removed and/or inactivated during the course of the plasma fractionation process. However, specific virus inactivation steps must be included in the manufacturing process for most blood products. The stage at which these steps should be introduced and the efficacy and drawbacks of various procedures are described.
在工业规模上,血液制品是由汇集了数千名献血者捐赠血浆的血浆库生产的。由于在传染病症状显现之前,献血者体内可能存在多种病原体,这些病原体,尤其是病毒,可能会通过人类血液制品传播。通过一系列血清学检测和聚合酶链反应筛查,病毒污染水平可大幅降低。在血浆分离过程中,病毒也可被去除和/或灭活。然而,大多数血液制品的制造过程必须包含特定的病毒灭活步骤。本文描述了这些步骤应在哪个阶段引入以及各种程序的功效和缺点。