Consequences of Nucleic Acid Amplification Testing for Blood Transfusion Centres
Consequences of Nucleic Acid Amplification Testing for Blood Transfusion Centres
复制标题
输血中心核酸扩增检测的后果
作者：
A. Couroucé;L. Noel;F. Barin;M. Elghouzzi;F. Lunel;M. North;W. Smilovici;A. Sáez;M. Otani;E. Sabino;G. Ribeiro‐dos‐Santos;N. Salles;D. Chamone;K. Koerner;M. Cardoso;T. Dengler;M. Kerowgan;B. Kubanek;E. Mauser;H. Zaaijer;A. Drimmelen;S. Vries;G. Roosendaal;H. Berg;P. Lelie;Sharon X. Chen;D. Hammond;J. Lang;R. LebingWytold;J. Moulds;S. Hayes;T. D. Wells;J. Winters;K. Ogasawara;R. Yabe;M. Uchikawa;M. Bannai;K. Nakata;M. Takenaka;Yuji Takahashi;T. Juji;K. Tokunaga;D. Stahl;H. Kreft;H. Hack;B. Schraven;D. Roelcke;C.D.Jennings;N. Desai;L. G. Dickson;R. F. Ford
这篇文章也可在线访问：http://BioMedNet.com/karger血库和输血中心面临着即将引入的核酸扩增检测（NAT），或血浆行业使用的血浆池的基因组扩增检测。欧洲专利药品委员会（CPMP）要求在1999年7月1日前通过NAT检测所有生产的血浆池中的HCV RNA。为了避免大量NAT反应性血浆池的破坏，CPMP强烈建议实施一个通过NAT筛选小型血浆池的系统。将来，预计对个体捐献的血液传播病毒进行基因组筛选将成为强制性的。目前，不能常规地进行个体捐献的基因组筛查，并且NAT微库筛查（即，100个捐献的血浆库）不是（良好地）标准化的，是昂贵且耗时的，特别是当必须从阳性库中分选出个体阳性捐献者时。一个特别困难的伦理问题是，当实施微池筛查时，关于红细胞产品，特别是血小板的放行，应该做出什么决定。这些细胞产物将被阻断至少几天，造成产品短缺和损失，或者微池筛选试验的结果不会影响这些产品。这可能会产生不同程度的安全性和严重的道德问题，因为在获得阳性结果后通知（或不通知）这些产品的接受者。向该领域的14名专家征求了意见，其中10名专家对以下问题作出了答复。
This article is also accessible online at: http://BioMedNet.com/karger Blood banks and transfusion centres are faced with the imminent introduction of nucleic acid amplification testing (NAT), or genomic amplification testing of plasma pools used by the plasma industry. The Committee for Proprietary Medicinal Products (CPMP) in Europe requires that all manufactured plasma pools should be tested for HCV RNA by NAT by July 1, 1999. To avoid the destruction of large NAT-reactive plasma pools, the CPMP strongly advises to implement a system for the screening of minipools of plasma by NAT. In future, genomic screening of individual donations for blood-borne viruses is expected to become obligatory. At present, genomic screening of individual donations cannot be routinely performed, and NAT minipool screening (i.e. a pool of plasma of 100 donations) is not (well) standardized, is costly and time-consuming, especially when the individual positive donors from a positive pool have to be sorted out. An especially difficult and ethical question is what should be decided concerning the release of red cell products and especially platelets when minipool screening is implemented. Either these cellular products will be blocked for at least several days, creating shortage and loss of product, or the results of minipool screening tests will not affect these products. This may create different levels of safety and serious ethical problems by informing (or not informing) recipients of these products after a positive result has been obtained. Fourteen experts in the field were asked for their opinion, answers were obtained from 10 of them on the following questions.