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The FDA will refrain from testing all donated blood and blood products against the Zika virus, the agency said Friday.
Citing the decrease in Zika cases in the United States, as well as profitability and the desire to make the process less cumbersome, the FDA revised its interim guidance as of August 2016, which stipulated that all Blood and blood products had to be tested for the virus.
The agency issued a revised final orientation document explaining the new policy. They stated: "In order to comply with the applicable testing regulations, blood establishments must continue to test all donations of whole blood and blood components for the Zika virus using an acid test. nucleic '. But they added that pooled donation using an FDA-authorized screening test may be sufficient unless there is a higher risk of virus transmission by local mosquito in a specific geographic area, which trigger an individual donation test. ] "When the Zika virus appeared, the unknown evolution of the epidemic and the severe observed effects of the disease indicated that individual tests were necessary to ensure the safety of the blood supply", Peter Marks, MD, Ph.D. Center for Evaluation and Research in Biology, said in a statement. "Now, given the significant decrease in cases of Zika virus infection in the United States and its territories, we avoid testing each individual donation to test group donations."
When interim guidelines appeared, the US month removed the first cases of locally transmitted Zika virus in South Florida. But the Red Cross protested against these interim guidelines at a meeting in November with the FDA, saying that it was costly to hospitals and that the process had found that only a handful of donations tested positive for the virus
. This study was supported by a study published in 1945 in the New England Journal of Medicine (1945-19005), which found nine confirmed Zika positive cases among almost four million donations, and that the expected annual cost of screening national would be $ 137 million.
The FDA stated that she "will continue to monitor the situation closely and, if necessary, that she will reconsider the measures necessary to maintain the safety of the blood supply," she said. said Marks.
2018-06-07T00: 00: 00-0400
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