First Zika‐positive donations in the continental United States

• DOI: 10.1111/trf.14029
• Publication Date: 2017-02-05T22:17:14Z
• Authors: Susan A. Galel; Phillip C. Willia...; Michael P. Busch; Danielle Stanek; Sonia Bakkour; Mars Stone; Kai Lu; Scott Jones; Susan N. Rossmann; Lisa Lee Pate
• Keywords: Zika Virus; Sexual transmission; Nucleic acid test

BACKGROUND Zika virus (ZIKV) has spread in the Americas, including parts of southern United States, and infection can be associated with serious complications, congenital brain abnormalities. Probable transfusion transmission ZIKV been documented Brazil. STUDY DESIGN AND METHODS Preemptive testing blood donations for RNA was implemented US states at risk local using a test approved under Food Drug Administration (FDA) investigational new drug application, cobas Zika. Screening expanded after issuance an updated FDA guidance. Donations reactive on initial screening were further tested by nucleic acid antibody tests to determine donor status. RESULTS Of 358,786 from screened individual donation testing, 23 initially Fourteen these represented probable based reactivity additional or anti‐Zika immunoglobulin M. Ten 14 donors reported travel identified ZIKV‐active area within 90 days before (median time end donation, 25 days; range, 6‐71 days). Three history also had potential sexual exposure. Only seven detectable upon 1:6 dilution simulate minipool testing. The estimated specificity 99.997%. CONCLUSION interdict ZIKV‐infected donors. Donor factors include more than 4 weeks Minipool would have detected only 50% RNA‐positive donations.