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Nucleic acid testing: American Red Cross experience

机译:核酸测试:美国红十字会经验

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The US blood supply has been tested for HIV-1 and HCV using Nucleic Acid Amplification Testing (NAT) of small pools since early in 1999. Since the implementation of NAT under an investigational new drug (IND) application, the results for yield and false positivity have been amazingly consistent for greater than two years of testing even among multiple programs using two different test methodologies and manufacturers: Gen-Probe/Chiron transcription-mediated amplification (TMA) and Roche PCR. All programs in the US and Canada use NAT as a criterion for cellular as well as frozen product release. The focus of this manuscript is to provide an update of the programs in the US and Canada, provide data in support of p24 antigen replacement by HIV-1 NAT, and discuss the projections of residual risk of HIV, HCV and HBV following NAT and the associated cost/benefit.
机译:自1999年初以来,已经使用小池核酸扩增检测(NAT)对美国的血液供应进行了HIV-1和HCV的检测。自从在新药(IND)研究性应用中实施NAT以来,结果的产生和错误在过去的两年多的测试中,即使使用两种不同的测试方法和制造商进行的多个程序之间,Gen-Probe / Chiron转录介导的扩增(TMA)和Roche PCR的阳性反应也具有惊人的一致性。美国和加拿大的所有程序都将NAT用作细胞以及冷冻产品释放的标准。该手稿的重点是提供美国和加拿大计划的更新,提供支持HIV-1 NAT替代p24抗原的数据,并讨论NAT和HBV感染后HIV,HCV和HBV的残留风险预测。相关的成本/收益。

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