Farrugia A
Blood and Tissues unit, Office of Devices, Blood and Tissues, Australian Therapeutic Goods Administration, PO Box 100, Woden ACT, Australia 2606.
Haemophilia. 2004 Jul;10(4):334-40. doi: 10.1111/j.1365-2516.2004.00911.x.
Plasma may be procured for use as a therapeutic product or as a raw material for manufacture of other products, and may be collected as a by-product of whole blood, or as a plasma donation from aphaeresis. When collected for fractionation, the quality and safety of the plasma are intimately linked to the quality and safety of the manufactured plasma derivatives. High quality plasma can be obtained either from whole blood or from plasmapheresis; quality can, however, be adversely affected by poor storage conditions after collection. Quality standards for plasma for fractionation are necessarily different than for plasma for transfusion and, with modern fractionation methods, certain quality aspects become less relevant. Similarly, the relevance of certain recent technological advances, such as nucleic acid testing (NAT), for maximizing the safety of plasma for fractionation are questionable, although their introduction through the linkage of recovered plasma to whole blood collection can improve the safety of fresh blood components. Viruses that are not screened for at blood banks may also be excluded from the plasma pool they are more clinically relevant when multiple products made from a pool may infect a large number of recipients, in contrast to components given to one or a small number of patients.
血浆可采集用作治疗产品或作为制造其他产品的原材料，可作为全血的副产品采集，也可通过单采血浆术采集自献血者。当为了成分分离而采集时，血浆的质量和安全性与制成的血浆衍生物的质量和安全性密切相关。高质量的血浆可从全血或单采血浆术中获得；然而，采集后的储存条件不佳可能会对质量产生不利影响。用于成分分离的血浆的质量标准必然不同于用于输血的血浆，并且在现代成分分离方法下，某些质量方面的相关性降低。同样，尽管通过将回收血浆与全血采集相联系引入核酸检测（NAT）等某些最新技术进步可提高新鲜血液成分的安全性，但对于最大限度提高用于成分分离的血浆的安全性而言，其相关性存疑。血库未筛查的病毒也可能被排除在血浆库之外，与输给一名或少数患者的成分相比，当由一个血浆库制成的多种产品可能感染大量受者时，这些病毒在临床上的相关性更强。
