The U.S. Food and Drug Administration (FDA) recently classified the Zika virus as a transfusion-transmitted infection and called on all U.S. blood centers to start universal screening of donated whole blood and blood components for the virus. While a necessary step to protect the nation’s blood supply, experts say that immediate implementation is likely to pose a challenge for some blood banks and for the third-party laboratories. According to the American Red Cross nearly 14 million units of whole blood and red blood cells are collected each year from about seven million donors. While the number of confirmed U.S. cases of Zika is still small in comparison, Zika has been detected in blood donated from asymptomatic individuals in Puerto Rico and there are reports of probable transfusion-transmission of Zika in Brazil. As “precautionary measures” the FDA called for immediate implementation of nucleic acid testing of all donations and use of an approved pathogen reduction technology for platelets and plasma donations. Currently there are no approved Zika tests, however two tests are available under an investigational new drug application—Roche’s cobas Zika assay and Hologic’s Procleix Zika virus blood screening assay. The cost of adding Zika testing to the blood screening process […]