FDA News

FDA recommends Zika testing for all US blood donations

Today, the FDA expanded its recommendation for Zika virus testing to include all donated whole blood and blood components acquired in the U.S. and its territories.

Prior guidance released in February recommended only that areas with active transmission screen donated blood products for the virus, or take steps to reduce the risk of contaminated blood. According to today’s revision, the agency now recommends all donations be screened using a licensed test, or one authorized for use by the FDA under an investigational new drug application. The guidance also advocates the use of an FDA-approved pathogen-reduction device for donated plasma and certain platelet products.

“As new scientific and epidemiological information regarding Zika virus has become available, it’s clear that additional precautionary measures are necessary,” Luciana Borio, MD, acting chief scientist of the FDA, said in a press release. “We are issuing revised guidance for immediate implementation in order to help maintain the safety of the U.S. blood supply.”

According to the release, this new guidance is the result of consultation with other public health agencies, risk assessment and a review of all currently available evidence. Because the currently implemented system of testing donations has been beneficial in Florida, Puerto Rico and other affected areas, the recommendation to expand Zika testing “will be in effect until the risk of transfusion transmission of Zika virus is reduced,” the agency wrote.

Peter Marks
Peter Marks

“There is still much uncertainty regarding the nature and extent of Zika virus transmission,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “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.”

Reference:

FDA. Revised recommendations for reducing the risk of Zika virus transmission by blood and blood components. http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM518213.pdf. Accessed Aug. 26, 2016.

Disclosure: Infectious Disease News was unable to confirm Borio’s and Marks’ disclosures at the time of publication.

Today, the FDA expanded its recommendation for Zika virus testing to include all donated whole blood and blood components acquired in the U.S. and its territories.

Prior guidance released in February recommended only that areas with active transmission screen donated blood products for the virus, or take steps to reduce the risk of contaminated blood. According to today’s revision, the agency now recommends all donations be screened using a licensed test, or one authorized for use by the FDA under an investigational new drug application. The guidance also advocates the use of an FDA-approved pathogen-reduction device for donated plasma and certain platelet products.

“As new scientific and epidemiological information regarding Zika virus has become available, it’s clear that additional precautionary measures are necessary,” Luciana Borio, MD, acting chief scientist of the FDA, said in a press release. “We are issuing revised guidance for immediate implementation in order to help maintain the safety of the U.S. blood supply.”

According to the release, this new guidance is the result of consultation with other public health agencies, risk assessment and a review of all currently available evidence. Because the currently implemented system of testing donations has been beneficial in Florida, Puerto Rico and other affected areas, the recommendation to expand Zika testing “will be in effect until the risk of transfusion transmission of Zika virus is reduced,” the agency wrote.

Peter Marks
Peter Marks

“There is still much uncertainty regarding the nature and extent of Zika virus transmission,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “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.”

Reference:

FDA. Revised recommendations for reducing the risk of Zika virus transmission by blood and blood components. http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM518213.pdf. Accessed Aug. 26, 2016.

Disclosure: Infectious Disease News was unable to confirm Borio’s and Marks’ disclosures at the time of publication.