JOINT BASE SAN ANTONIO-FORT SAM HOUSTON, Texas –
Researchers at the U.S. Army Institute of Surgical Research, or USAISR, at Joint Base San Antonio-Fort Sam Houston recently initiated a study to ensure that all blood collected at Department of Defense blood collection facilities is free from the Zika virus and are continuing to test all blood donations for the foreseeable future.
Testing for the Zika virus in donor blood began in the fall of 2016 after the Zika outbreak in Puerto Rico prompted officials from the U.S. Food and Drug Administration to shut down blood collection on the island and mandated that all FDA-regulated blood collection centers in the U.S. test for Zika.
Participation in the testing for the 20 DOD collection centers around the world from Guam to Germany was mandatory and failure to comply meant that all facilities would be shut down.
According to Lt. Col. (Dr.) Andre Cap, USAISR chief of blood research, the first of the 20 facilities began testing in September 2016 and all were compliant by January 2107 in accordance with FDA’s mandated schedule for testing implementation.
“We are essentially running a 20-site clinical trial,” Cap said. “It was a difficult task, but it was an urgent matter to keep the facilities from getting shut down.”
Shutting down DOD blood collection facilities would mean a shortage of blood to troops deployed to austere locations and those supporting overseas contingency operations.
“The urgency of this study was to keep the facilities open,” Cap added. “We coordinated this effort with the three services and the Armed Services Blood Program and we got all blood donors tested for Zika to make sure that the DOD’s blood supply that goes downrange is Zika-free.”
Chriselda Fedyk, USAISR blood research trial coordinator, worked with Roche Molecular Diagnostics, the developer of the blood testing process, the U.S. Army Medical Research and Materiel Command Institutional Review Board, and the service blood programs to launch the study.
The trial was implemented in three phases according to Zika transmission risk: the first phase was for blood collection facilities in the southern U.S., to include Guam and Hawaii, then the facilities in the central U.S., and the final phase in the northern portion of the country.
Testing for Zika will continue until the FDA approves a license for a testing protocol. The protocol used for testing DOD blood supplies was one of two granted by the FDA under an investigational new drug, or IND, application. The data collected from the USAISR study will go toward the licensing process for the IND. Once the license is granted, the testing protocol will end and Zika testing will become a routine part of blood safety evaluation.
“The good news is that we’ve had very few positive donors and we’ve been able to comply with the FDA mandate. Retesting the positive blood has come back negative in subsequent tests,” Cap said. “It will be interesting to see what happens this year because we are getting close to the mosquito season.”