Pre-pivotal Procleix Zika Virus Assay Testing of Donations From Donors of Whole Blood and Blood Components

2016年8月，美国FDA要求所有美国血液中心对所有献血者进行寨卡病毒RNA检测，并根据FDA Ind进行检测。 2016年12月12日，美国国立卫生研究院临床中心输血医学部开始对献血者进行寨卡病毒RNA检测。NIH不对捐赠者的血小板进行寨卡病毒RNA检测，因为NIH的血小板是通过FDA批准的病原体减少系统减少的病原体，FDA不要求对寨卡病毒进行检测。 所有测试都是在FDA IND的指导下，经过NIH NIAID IRB的审查和批准，使用Hologics，Inc.Procleix寨卡病毒检测进行的。自实施捐赠者检测以来，使用Procleix寨卡病毒检测对4278名捐赠者进行了筛查，N=0为寨卡病毒RNA阳性。

In August of 2016, the U.S. FDA mandated that all U.S. blood centers test all blood donors for Zika virus RNA with a test under an FDA IND. The NIH Clinical Center Department of Transfusion Medicine began blood donor testing for Zika virus RNA on December 12, 2016. The NIH does not test donor platelets for Zika virus RNA because NIH platelets are pathogen reduced with an FDA-approved pathogen reduction system, and are not required by FDA to be tested for Zika virus. All testing was performed with the Hologics, Inc. Procleix Zika Virus Assay under an FDA IND and after NIH NIAID IRB review and approval. Since implementation of donor testing, 4,278 donors were screened using the Procleix Zika Virus Assay, and N=0 were positive for Zika virus RNA.