FDA Approves Experimental Zika Test for Blood Donations
WEDNESDAY, March 30, 2016 (HealthDay News) -- An experimental test to check blood donations for the Zika virus has been approved by the U.S. Food and Drug Administration.
The decision to allow use of the test in areas with active mosquito-borne transmission of the virus means that collections of whole blood and blood component donations will be able to resume in Puerto Rico, agency officials said.
"The availability of an investigational test to screen donated blood for Zika virus is an important step forward in maintaining the safety of the nation's blood supply, especially for those U.S. territories already experiencing active transmission," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said Wednesday.
"In the future, should Zika virus transmission occur in other areas, blood collection establishments will be able to continue to collect blood and use the investigational screening test, minimizing disruption to the blood supply," he explained in an FDA news release.
Zika is a mosquito-borne virus that's been tied to thousands of cases -- mainly in Brazil -- of a severe birth defect called microcephaly. In microcephaly, a newborn's head is smaller than normal, with the potential for long-term neurological damage.
The Zika virus has now spread to over 38 countries and territories, most in Latin America and the Caribbean.
Due to the Zika outbreak, local blood collection in Puerto Rico was suspended earlier this year. On March 7, the U.S. Department of Health and Human Services said shipments of blood and blood products would be sent from the continental United States to Puerto Rico.
The FDA is still recommending that anyone who has traveled recently to an area where the Zika virus is active to defer donating blood.
The blood test is made by New Jersey-based Roche Molecular Systems, Inc.
Zika infection is usually a transient, mild illness in adults, and many cases may occur without symptoms, experts say. However, because of the risk to babies, the U.S. Centers for Disease Control and Prevention is advising that men with known or suspected infection with Zika refrain from sex -- or only have sex with a condom -- for six months after a diagnosis.
The agency also advises that, for couples involving a man who has traveled to or resides in an area endemic for Zika:
- The couple refrain from sex, or use condoms during sex, throughout the duration of a pregnancy.
- They refrain from sex, or use condoms during sex, for eight weeks if the man has returned from travel to a Zika-endemic area but has not shown signs of infection.
- For couples living in a Zika-endemic area, they refrain from sex or engage in sex only with a condom for as long as active Zika transmission persists in that area.
The latest guidelines also recommend that women who know they've been infected, or who have no symptoms but have recently been to a Zika-endemic area, or who think they might have been exposed via sex, should wait at least eight weeks before trying to get pregnant.
The CDC has also advised that all pregnant women consider postponing travel to any area where Zika virus transmission is ongoing. If a pregnant woman must travel to or live in one of these areas, she should talk to her health-care provider first and strictly follow steps to prevent mosquito bites.
The Zika virus was first discovered in Uganda in the late 1940s and wasn't thought to pose major health risks until last year, when it became clear that it was a potentially devastating threat to pregnant women.
The virus is not expected to pose a significant threat to the U.S. mainland, federal health officials have said in the past.
In Puerto Rico, however, the situation is "of great concern," CDC Director Dr. Tom Frieden said earlier this month.
For more on Zika virus, visit the U.S. Centers for Disease Control and Prevention.
To see the CDC list of sites where Zika virus is active and may pose a threat to pregnant women, click here.