The US Food and Drug Administration (FDA) has approved the first test designed to screen blood donations for Zika virus.
The cobas Zika test is a qualitative nucleic acid test that can detect Zika virus RNA in individual plasma specimens obtained from donors of whole blood and blood components and from living organ donors.
The test is not intended for the individual diagnosis of Zika virus infection.
The cobas Zika test is intended for use on the fully automated cobas 6800 and cobas 8800 systems. These systems and the test are manufactured by Roche Molecular Systems, Inc.
“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.
“Screening blood donations for the Zika virus is critical to preventing infected donations from entering the US blood supply. Today’s approval is the result of a commitment by the manufacturer to work rapidly and collaboratively with the FDA and the blood collection industry to respond to a public health crisis and ensure the safety of blood in the US and its territories.”
In August 2016, the FDA issued a guidance document recommending that all states and territories screen individual units of whole blood and blood components with an investigational blood screening test available under an investigational new drug (IND) application, or use an approved test when available.
Several blood collection establishments have used the cobas Zika test under an IND. The data collected from this testing and additional studies performed by the manufacturer demonstrated that the test is effective in screening blood donors for Zika virus infection, according to the FDA.
The test’s clinical specificity was evaluated by testing individual samples from blood donations at 5 external laboratory sites, and the specificity exceeded 99%.
