The agency issued a revised guidance recommending universal testing of donated whole blood and blood components for Zika virus in the US and its territories.
In Florida, Puerto Rico and other areas, donated blood is already being tested under this revised guidance. The FDA says that it has been found to be beneficial in detecting Zika virus-infected donations.
FDA Center for Biologics Evaluation and Research director Peter Marks said: “There is still much uncertainty regarding the nature and extent of Zika virus transmission.
“At this time, the recommendation for testing the entire blood supply will help ensure that safe blood is available for all individuals who might need transfusion.”
In its first guidance issued on February this year, the FDA had recommended that only areas with active Zika virus transmission screen donate whole blood and blood components for the virus.
Additionally, these areas were to use pathogen-reduction devices or alternately stop blood collection, while obtaining whole blood and blood components from the non Zika virus affected US areas.
Currently, all the US regions with active transmission of Zika virus are following this February-issued guidance as per the FDA.
As per the revised guidance, screening is to be done using an FDA-authorized blood screening test under an investigational new drug (IND) application or a licensed test whenever it is available.
The FDA has also given an option of using its approved pathogen –reduction device for plasma and select platelet products.
It also says that it will continue in expanding tests to cut down the risk of Zika virus transmission through the country’s blood supply.
The duration of these tests will be until the risk of Zika virus transfusion transmission is brought down.
