FDA approves first Zika virus test for blood donations

Peter Marks

The FDA has approved the first Zika virus test for blood donations, the agency announced.

The cobas Zika test (Roche Molecular Systems) detects the virus’ RNA in plasma specimens from donors of whole blood and blood components, as well as from living organ donors. The test is aimed at detecting Zika virus in donated blood but not for the diagnosis of the virus in individual people, an FDA release said.

“Screening blood donations for the Zika virus is critical to preventing infected donations from entering the U.S. blood supply,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement.

Marks added that the cooperative effort involving Roche and the FDA will help officials to “ensure the safety of blood in the U.S. and its territories.”

In August 2016, the FDA recommended that all U.S. states and territories screen blood and blood components with the cobas test, which was under an investigational new drug application. Since then, the agency’s statement read, several blood collection groups used the test under FDA guidelines.

Those tests and studies conducted by Roche showed that the cobas test is effective, the statement said, adding that testing at five external laboratories showed clinical specificity of more than 99%. – by Joe Green

Reference: FDA. FDA approves first test for screening Zika virus in blood donations. 2017. http://www.who.int/mediacentre/news/releases/2017/antibiotics-plague-madagascar/en. Accessed Oct. 6, 2017.

Disclosure: Marks reported no relevant financial disclosures.