Zika Virus Blood Screening Guidelines Revised by FDA

The U.S. Food and Drug Administration (FDA) has revised its recommendations for testing blood donations for the Zika virus, allowing for pooled testing of donations using a screening test it has licensed. The revised guidance replaces guidance announced in August 2016 that recommended universal nucleic acid testing for Zika virus of individual units of blood donated in U.S. states and territories. Roche’s cobas Zika test for use on the cobas 6800 and 8800 PCR systems enables streamlined screening of multiple individual blood or plasma donations that have been pooled together. The test is a qualitative in vitro nucleic acid screening test for the direct detection of Zika virus DNA in plasma specimens from individual human blood donors. According to Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, the new approach is usually more cost-effective and less burdensome for blood establishments.

“When Zika virus first emerged, the unknown course of the epidemic and the observed severe effects from the disease indicated that individual donor testing was needed to ensure the continued safety of the blood supply,” explained Marks. “Now, given the significant decrease in cases of Zika virus infection in the U.S. and its territories, we are moving away from testing each individual donation to testing pooled donations. [However, FDA] will continue to monitor the situation closely, and as appropriate, reconsider what measures are needed to maintain the safety of the blood supply.”