FDA Approves First Test to Detect Zika Virus in Blood Donations

Yesterday, October 5, 2017, the US Food and Drug Administration (FDA) approved the cobas Zika test—a qualitative nucleic acid test created to detect Zika virus RNA in individual donor plasma specimens collected from volunteer donors (of whole blood and blood components) as well as living organ donors.

Blood collection establishments will be able to utilize the test to identify Zika in blood donations, not so much 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,” Dr. 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 United States and its territories."

The Zika virus—primarily transmitted through mosquitos—is also known to spread via blood transfusion and sexual contact. Common symptoms can include any of the following: fever, joint pain, maculopapular rash, and conjunctivitis. The virus is known to cause serious neurological disease in adults and birth defects, such as microcephaly.

In August 2016, the FDA issued a recommendation for states and territories 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 the 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 specificity of 99%.

As part of the fully automated cobas 6800 and cobas 8800 systems, the test is manufactured by Roche Molecular Systems, Inc.