FDA Calls For All Blood Donations to be Tested for the Zika Virus
The South Texas Blood & Tissue Center (STBTC) received notification on August 26, 2016 from the U.S. Food and Drug Administration that, within the next four weeks, all blood donations collected in Texas and 10 other states at high risk for active Zika transmission must be tested for the virus. Testing on collections from the remaining states must begin within the next 12 weeks.
All those who want to donate must consent to the testing of their donation for the virus. STBTC, which began testing donations for Zika on July 5, was the second center in the United States to announce testing for the virus.
While the center has had more than 10,000 units tested since July, not all donors are providing consent for testing. According to Dr. Rachel Beddard, medical director, about 12 percent of donors are not consenting, a number the blood center is working to improve.
“If you would like to donate blood or platelets, consenting to the test is no longer an option; now it’s a directive,” Beddard said. “We are educating donors that consentingto have their blood screened for Zika is just like consenting to have it tested for HIV, hepatitis and other diseases. It’s just another test, but because it’s new, the FDA requires donors to sign an extra document.”
In Florida, which is the only state that has reported cases of Zika spread by mosquitoes, centers had to stop collecting blood until testing or a pathogen reduction technology was implemented.
“The good news is that we are ahead of the curve, with processes in place, because we believe testing is the best way to safeguard patients in South Texas who need blood transfusions,” said Elizabeth Waltman, chief operating officer of STBTC. “The next step is to educate our donors about the importance of consenting to testing to ensure not only the safety of the blood supply, but to ensure an adequate supply is available for hospitals and patients in our community.”
Testing for the Zika virus is being done by QualTex Laboratories, which like STBTC is a subsidiary of San Antonio-based nonprofit BioBridge Global. QualTex currently does all testing of blood donations for STBTC.
“The testing does not change anything about the donation process, except for this one extra signature. And the more Zika-tested blood we have on our shelves for patients, the less risk there is for everyone,” Waltman said.
According to the CDC, about 80 percent of people who have contracted Zika show no symptoms, which makes testing blood donations all the more vital. A person who feels well may actually have the virus while donating blood. And unlike other mosquito-borne viruses such as West Nile, Zika can be transmitted through sexual contact, which poses an additional public health risk, and to unborn babies by their mothers.
What researchers are learning about the Zika virus continues to evolve. To protect the blood supply, it’s important to get ahead of the curve to detect infection through testing, which was an important lesson from the HIV epidemic in the ’80s.
“The blood supply often is the canary in the coal mine when it comes to detecting infectious-disease outbreaks,” Beddard said. “Because of the extensive testing done on blood donations, infections that otherwise might not have been caught show up, and we can stop that blood from getting into the supply for patients.”
The FDA recommended centers in Texas, Alabama, Arizona, California, Georgia, Hawaii, Louisiana, Mississippi, New Mexico, New York and South Carolina begin testing within the next four weeks “because of their proximity to areas with locally acquired mosquito-borne cases of ZIKV (Zika virus) or because of other epidemiological linkage to ZIKV, such as the number of travel-associated cased reported.”
Zika virus infections have been linked to the birth defectmicrocephaly, in which a baby is born with an underdeveloped head and brain, as well as other problems in newborns. It also has been tied to a rare neurological condition called Guillain-Barré Syndrome in adults. Symptoms of Zika virus infection can include a fever, rash, joint pain and/or red eyes.
The Aedes aegypti mosquito that carries Zika is endemic to the southern parts of the country, including South Texas. The virus also can be spread via sexual contact and blood transfusion.
The Zika virus test is a new technology developed by the biotech firm Roche. It has been approved for clinical trial by the FDA under an investigational new drug (IND)protocol, which means donors must give written consent for their blood to be tested, and results will be used in research.
The signature of a parent or guardian is required on the Zika test consent form for donors younger than 18. Any donor who tests positive for Zika will be notified.
All donors must present identification. Anyone who is 16 years old and weighs at least 120 pounds (with a parental consent form), or 17 years old and weighs at least 110 pounds, and is in good general health may donate blood.
News about the Zika virus is available on the BioBridge Global website, and general information is available from the Centers for Disease Control and Prevention.