FDA approved the first test that detects the Zika virus in blood donations and living organ donations.
Last year, FDA also approved the first widely available test for the Zika virus from Quest Diagnostics.
Now, the cobas Zika test (Roche Molecular Systems), a qualitative nucleic acid test for the detection of Zika virus RNA, is available. The test applies to individual plasma specimens obtained from volunteer donors of whole blood and blood components, and from living organ donors.
“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, in a statement from FDA. “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,” Marks added.
In August, 2016, FDA issued a final 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 a licensed (approved) test when available.
Before today, several blood collection establishments used the cobas Zika test under IND in order to follow the recommendations in the FDA’s 2016 guidance document. “The data collected from this testing, and from additional studies performed by the manufacturer, demonstrated that the cobas Zika test is an effective test to screen blood donors for Zika virus infection,” FDA said.
After testing individual samples from blood donations at five external laboratory sites, there was a clinical specificity of more than 99%.