The US Food and Drug Administration (FDA) has approved the cobas Zika screening test for the detection of virus RNA in plasma specimens taken from donated whole blood and blood components and from living organ donors, according to a statement released by the organization.
Although the test is only intended to screen for the virus in blood donations and not to diagnose individuals, the test will help protect the nation’s blood supply, which is vital as the virus can spread through blood transfusions.
“Today’s action represents the first approval of a Zika virus detection test for use with screening the nation’s blood supply,” said Peter Marks, MD, PHD, director of the FDA’s Center for Biologics Evaluation and Research.
Researchers assessed the test’s clinical specificity by testing individual blood donation samples at 5 external laboratory sites, resulting in a specificity of more than 99%.
Testing for Zika virus in blood products follows FDA recommendations issued in 2016 calling for the screening of individual units of whole blood and blood components.
FDA approves first test for screening Zika virus in blood donations [press release]. Silver Spring, Maryland: US Food and Drug Administration. Updated October 5, 2017. Accessed October 6, 2017.