LAUSR

The U.S. Department of Defense (DoD) collects blood from volunteer DoD donors in U.S. Food and Drug Administration (FDA)‐regulated centers, and from emergency donor panels in overseas operations. Emerging infectious diseases could reduce DoD access to blood products. In August 2016, FDA determined that Zika virus was transfusion‐transmitted and advised that donated blood should be screened for Zika utilizing one of two investigational new drug (IND) applications. The Armed Services Blood Program (ASBP) tested blood using its own protocol concurrently with the IND study sponsored by Roche Molecular Systems, Inc., titled “A Prospective Study to Evaluate the Specificity of the cobas Zika test for use on the cobas 6800/8800 System for Screening of Blood Donations for the Presence of Zika virus RNA.”