This was the first FDA approval of such a detection test for screening national blood supplies.
The US Food and Drug Administration (FDA) approved a qualitative nucleic acid test that is designed to detect Zika virus RNA in individual donor plasma specimens.
The cobas Zika test works to detect the virus in volunteer donors of whole blood and blood components, as well as from living organ donors. Blood collection establishments will be able to use the test to detect Zika in blood donations — but not for individually diagnosing Zika virus infection.
Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said this was the first FDA approval of such a detection test for screening national blood supplies.
“Screening blood donations for the Zika virus is critical to preventing infected donations from entering the U.S. blood supply,” Marks said. “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 U.S. and its territories."
The Zika virus, primarily transmitted through mosquitos, can also spread through blood transfusion and sexual contact. Symptoms include fever, joint pain, maculopapular rash, and conjunctivitis. The virus is known to cause serious neurological disease in adults and birth defects in pregnant women.
The FDA had issued a recommendation for states and territories in August 2016 to screen individual units of blood with an investigational screening test available under an investigational new drug (IND) application or an approved test.
Since then, multiple blood collection establishments had used that cobas Zika test under IND to follow the recommendation. In data collected from the uses, as well as additional manufacturer studies, the cobas Zika test proved effective. It returned a clinical specifity of 99%.
As part of the fully automated cobas 6800 and cobas 8800 systems, the test is manufactured by Roche Molecular Systems, Inc.