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。 NIH临床中心输血医学部于2016年12月12日开始对献血者进行寨卡病毒RNA检测。 NIH不测试供体血小板的寨卡病毒RNA，因为NIH血小板是用FDA批准的病原体减少系统减少的病原体，并且FDA不要求进行寨卡病毒测试。 所有试验均由Hologics，Inc.进行。Procleix寨卡病毒检测试剂盒在FDA IND下进行，并经过NIH NIAID IRB审查和批准。 自实施供体检测以来，使用Procleix Zika病毒检测试剂盒筛查了4，278名供体，N=0为Zika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.