Themoving away from individual testing of donations and toward pooled testing.
“This [practice of pooled testing] is usually more cost effective and less burdensome for blood establishments,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in the. “However, the FDA will continue to monitor the situation closely and, as appropriate, reconsider what measures are needed to maintain the safety of the blood supply.”
The new testing recommendations reflect the decreasing number of cases of Zika virus infection in the U.S. and its territories, as well as advice from the agency’s Blood Products Advisory Committee.
The guidance makes an exception to its pooled testing recommendations: Donations from areas where a positive donation has been detected or in which the risk of mosquito-borne transmission of Zika virus is high should be tested individually. The guidance also allows the use of an FDA-approved pathogen-reduction device for plasma and certain platelet products.