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

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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 Hologic, Inc. Procleix Zika Virus Assay under an FDA IND and after NIH NIAID IRB review and approval. Since implementation of donor testing, 8,433 donors have been screened using the Procleix Zika Virus Assay, N=0 were positive for Zika virus RNA; N=1 was a false positive, a healthy female whole blood donor with no known risk factors for ZIKV infection initially resulted as ZIKV RNA positive. Subsequent confirmatory NAT testing, and additional antibody testing were negative. This study has been closed on February 2019.