Zika Virus Biovigilance Network

The AABB Zika Virus (ZIKV) Biovigilance Network platform was initiated in 2016 as a collaboration between AABB & U.S. blood collection establishments in response to the FDA’s first guidance on ZIKV, released in February 2016. It was modeled after AABB’s West Nile Virus (WNV) Biovigilance Network, initiated in 2006 by AABB’s WNV Task Force.

The ZIKV Biovigilance Network platform contained collection and reporting of data for donations with reactive ZIKV Nucleic Acid Test (NAT) results and mapped these data to U.S. geographical locations. Enhanced ZIKV reporting platform was deployed in December 2018 to support NAT for ZIKV described in the recommendations (including triggering ID NAT) issued in the July 2018 Food and Drug Administration (FDA) Guidance. AABB presented data from the platform during the March 2019 Blood Products Advisory Committee Meeting. In May 2021, FDA determined that ZIKV is no longer a relevant transfusion-transmitted infection (RTTI) under its regulations.

AABB’s ZIKV Biovigilance Network platform was discontinued on November 15, 2022.

A letter from Sharon Carayiannis, AABB’s Vice President, Science and Practice, to the ZIKV Biovigilance Network participants describes the details.

Key Findings

Data was downloaded on 9/22/2022.

• Between August 2016 and January 2021, a total of 889 initial reactive donations, including 654 false-positive results, 154 inconclusive with no additional testing planned, 46 confirmed positive, 33 inconclusive with results pending, 1 inconclusive with unresolved result and 1 donation with no test status, were reported.
• The last reactive donation reported to the platform was on 1/28/2021.
• The last confirmed positive ZIKV was reported on 3/16/2018 from a donor in Florida, with no exposure to travel or sexual contact identified.
• The highest number of donations with confirmed positive ZIKV NAT results were reported from the following states: Florida (20), California (9), New York (4), Texas (4), and Massachusetts (2).
• ZIKV Positive Predictive Value (PPV) of the NAT tests is 5.17%.
• The last confirmed positive case with exposure due to travel was associated with travel to Mexico in 12/2017.
• Among the confirmed positive cases, 29 cases had no known exposure of travel and sexual contact and 14 cases had a travel history.

For questions, please contact us at hemovigilance@aabb.org.