The U.S. Food and Drug Administration (FDA) has approved for the first time a test for detecting the Zika virus in donated blood.
The Zika virus is transmitted primarily by mosquitos (Aedes aegypti), but it can also spread through blood transfusion and sexual contact.
The cobas Zika test, manufactured by Roche Molecular Systems Inc., is intended for use by blood collection establishments to detect Zika virus in blood donations, not for the individual diagnosis of Zika virus infection, the FDA said on Thursday.
“Screening blood donations for the Zika virus is critical to preventing infected donations from entering the U.S. blood supply,” Peter Marks, Director of the FDA’s Centre for Biologics Evaluation and Research said.
It is a qualitative nucleic acid test for the detection of Zika virus RNA in individual plasma specimens obtained from volunteer donors of whole blood and blood components, and from living organ donors.
The test’s clinical specificity was evaluated by testing individual samples from blood donations at five external laboratory sites, resulting in clinical specificity of more than 99 per cent.