First Zika-positive donations in the continental United States.

Abstract:

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

journal_name

Transfusion

journal_title

Transfusion

authors

Galel SA,Williamson PC,Busch MP,Stanek D,Bakkour S,Stone M,Lu K,Jones S,Rossmann SN,Pate LL,cobas Zika IND Study Group.

doi

10.1111/trf.14029

subject

Has Abstract

pub_date

2017-03-01 00:00:00

pages

762-769

issue

3pt2

eissn

0041-1132

issn

1537-2995

journal_volume

57

pub_type

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