Test approved for Zika blood donations
The U.S. Food and Drug Administration has approved a test to detect the Zika virus in blood donations to help protect the public and the nation’s blood supply.
The test by Roche Molecular Systems, an international pharmaceuticals and diagnostic company, was in investigational stages last year when the Zika epidemic became widespread in Florida and Puerto Rico. The epidemic prompted the FDA to give permission to blood donation collection centers to use the still-investigational test to screen for contaminated blood.
The test is for use by blood collection centers only to detect the virus in blood donations. It is not intended for individual diagnosis of Zika, according to the FDA.
“Screening blood donations for the Zika virus is critical to preventing infected donations from entering the U.S. blood supply,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a news release.
The FDA’s approval is the result of the manufacturer’s commitment to work rapidly and collaboratively with the FDA and the blood collection industry to respond to a public health crisis, Marks said.
Florida became ground zero in 2016 for the virus, which is transmitted by the freshwater Aedes aegypti mosquitoes when they bite people. The virus also can be spread through blood transfusions and sexual contact involving an infected individual.
The virus has been quiet so far in 2017 with 179 cases statewide compared to 1,467 last year. There have been no locally transmitted cases in the state in 2017, where people get bitten by infected mosquitoes or from sexual contact, according to the Florida Department of Health.
“Since last summer, all blood donated in Florida has been screened for Zika,” Mara Gambineri, spokeswoman for the state health department in Tallahassee, said. “While we do not regulate blood banks, we worked closely with donation centers to ensure quick implementation of the test once it became available for experimental use by FDA last year.”
The health department is not aware of any proposed legislation that would make it mandatory for blood centers to screen for the Zika virus, she said. But since the FDA guidance last August to allow the test’s use before it gained final approval, the recommendation to all states in 2016 was to adopt it, she said.
Miami became a hub last year for what’s known as “travel-related” cases of Zika, when individuals who were infected in Puerto Rico or South American countries came to the U.S.
About one in five individuals who are infected exhibit symptoms of low-grade fever, rash and joint pain, while the most harm occurs to infants born to infected pregnant women. Zika infection in babies can result in microcephaly, a condition characterized by a small head, and developmental abnormalities can be lifelong.
Congress approved $1.1 billion for Zika late last fall, with $394 million directed toward mosquito control programs, $397 million for vaccine research and better diagnostics and $66 million for infected people, with the remainder to a variety or efforts.