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 15 travel-related Zika infections in Lee County this year, where the individuals became infected out of the U.S. In Collier, there have been five travel-related cases so far in 2017. 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 in an email. “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.
The Lee Health System, which operates five hospitals and numerous outpatient programs in Lee County, adopted the Zika screening tool last summer when the FDA issued its recommendation to add it, Lee Health spokeswoman Cheryl Garn said in an email.
“It is unknown what the cost of the kits will be now that licensing has been issued, however the safety of our blood products is a top priority at all Lee Health facilities,” 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.
When infected individuals transmit Zika through sexual contact, or when they are bitten by the Aedes aegypti mosquito and the mosquito transmit it through bites to others, those are classified as “locally transmitted” cases of Zika.
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.
Addressing the Zika virus statewide became a battle cry for Gov. Rick Scott last year who offered free testing to all pregnant women. He fought for federal funding to help with preventive measures and proactive surveillance. Scott earmarked $25 million of state funding toward Zika surveillance while Congress stalled, and the state funding later climbed to $61 million.
Congress ultimately 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.
Gov. Rick Scott criticizes the Obama administration for not doing enough to help Florida combat the Zika virus.
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