FDA approves first Zika Virus test for blood donations | My Page

FDA approves first test for screening Zika virus in blood donations

While the Zika virus is primarily transmitted by mosquito bites, it might also be passed through blood transfusion. to ensure that nobody who wants transfusion within the USA gets infected, the USA Food and Drug Administration has approved the first test that can screen Zika in blood donations. The cobas Zika test will detect the virus' rna in plasma taken from donated blood and blood parts. It cannot be used to diagnose infection, but it will keep the country's blood supply Zika-free.

The FDA actually allowed some clinics to use the technique as an experimental method to screen blood donations back in 2016 when the virus started spreading in Puerto RICO. due to that testing period, the FDA was ready to prove that the test will indeed effectively and accurately spot the virus. according to further tests in 5 external laboratories, its clinical specificity (or the frequency in negative results in uninfected subjects) is 99 %. currently that it's officially been approved, clinics and hospitals around the country will use it to make sure their blood supply won't infect anyone with the virus.

FDA Center for Biologics evaluation and director of research Peter Marks said during a statement:

"Today's action represents the first approval of a Zika virus detection test for use with screening the nation's blood supply. Screening blood donations for the Zika virus is critical to preventing infected donations from entering the U.S. blood supply. Today's approval is the result of a commitment by the manufacturer to work rapidly and collaboratively with the FDA and the blood collection industry to respond to a public health crisis and ensure the safety of blood in the U.S. and its territories."

source: webserveu.com