FDA changes guidance on testing blood donations for Zika

Blood banks no longer need to test individual donations for the Zika virus, the Food and Drug Administration said Friday.

FDA is instead recommending screening pooled donation, and said that testing individual samples may be necessary in parts of the world where Zika may be a particular concern. Pooled blood can now be tested with new screening tools that the FDA approved in May.

“The latest evidence shows that pooled donations can effectively reduce transmission of Zika in blood,” FDA Commissioner Scott Gottlieb said on Twitter. “It is also usually more cost effective and less burdensome for blood establishments.”

The agency cited the decrease in Zika cases in the U.S. and its territories as the reason for changing its recommendation, which has been in place since August 2016. At the time, cases of Zika were spreading rapidly through mosquitoes and through sex. The health consequences were particularly high for pregnant women, who risked giving birth to stillborn babies, having a miscarriage or giving birth to infants with microcephaly, a disorder characterized by abnormally small heads and brain damage.

A May study in the New England Journal of Medicine found nine confirmed positive cases of Zika among almost four million donations. It projected that the annual cost for screening all donations was $137 million.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said the agency would “continue to monitor the situation closely, and as appropriate, reconsider what measures are needed to maintain the safety of the blood supply.”

Blood donations get tested for a range of other illnesses, including hepatitis B and C, HIV and syphilis. The FDA also recommends testing for West Nile Virus and Chagas disease, which is spread through insects in Latin America.

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