This article is more than 5 years old. Information may no longer be current.

FDA authorizes test to screen blood donations for Zika virus

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

The FDA today announced that an investigational test used to screen Zika virus in blood donations is available for use in U.S. territories with active transmission.

“The availability of an investigational test to screen donated blood for Zika virus is an important step forward in maintaining the safety of the nation’s blood supply, especially for those U.S. territories already experiencing active transmission,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “In the future, should Zika virus transmission occur in other areas, blood collection establishments will be able to continue to collect blood and use the investigational screening test, minimizing disruption to the blood supply.”

Peter Marks

In February, the FDA issued guidance recommending blood collection agencies in areas with active Zika virus transmission obtain whole blood and blood components from areas without active transmission. As a result, local blood collection was suspended in Puerto Rico. The Department of Health and Human Services announced on March 7 that it arranged for shipments of blood donations from the continental United States to Puerto Rico. Once Zika screening with the investigational test (Roche Molecular Systems) begins, blood establishments in Puerto Rico may resume collecting donations, the release said. The FDA still recommends, however, that individuals with suspected or confirmed Zika virus infection should be deferred from donating blood for 4 weeks.

The FDA, along with the Office of the Assistant Secretary for Preparedness and Response/Biomedical Advanced Research and Development Authority, and the CDC, currently are assisting product manufacturers to develop blood donation screening assays, the release said.

Luciana Borio

“The close collaboration between the FDA and the product manufacturer was essential to expediting availability of this investigational test,” Luciana Borio, MD, the FDA’s acting chief scientist, said in the release. “This type of cooperation … requires a tremendous agency effort and underscored the importance of having adequate resources available to support essential Zika virus response activities.”

Disclosures: The researchers report no relevant financial disclosures.