FDA expands Zika screening
All U.S. blood banks included in order; Pa. has 3 months to comply
WASHINGTON — The government told all U.S. blood banks Friday to start screening for Zika, a major expansion intended to protect the nation’s blood supply from the mosquito-borne virus.
Previously, blood testing was mostly limited to parts of Florida and Puerto Rico, where Zika is spreading. Screening will initially extend to states along the Gulf Coast and a few others.
“There is still much uncertainty regarding the nature and extent of Zika virus transmission,” Dr. Peter Marks said in a Food and Drug Administration release. “At this time, the recommendation for testing the entire blood supply will help ensure that safe blood is available for all individuals who might need transfusion.”
Blood banks already test donations for HIV, hepatitis, West Nile and other blood-borne viruses. The Zika virus stays in the blood for about one week but is thought to remain in other bodily fluids longer.
The tropical mosquito that spreads Zika and other viruses is found in the southern U.S. The new directive lists 11 states that will need to begin screening blood in the next month because of their location or because of the influx of travelers from Zika outbreak countries.
On the list: Alabama, Arizona, California, Georgia, Hawaii, Louisiana, Mississippi, New Mexico, New York, South Carolina and Texas.
All other U.S. states and territories, including Pennsylvania, will have three months to comply.
Kristen Lane, spokeswoman for the Central Blood Bank in Pittsburgh, said the FDA’s recommendation was not unexpected.
“We knew something was going to happen,” she said. “Every day you hear more and more news about the way Zika is spreading. We just didn’t know when something would happen or in what form.”
To be proactive about Zika before the FDA guidance, Central Blood Bank this week began deferring from collecting blood from any person who had traveled or lived in the Miami-Dade area in the past 28 days.
The blood bank has reached out to vendors for Zika testing kits and will know more next week about cost, procedures and a timetable for testing, Ms. Lane said. The testing will be performed at the blood bank’s Green Tree facility.
The blood bank needs 400 to 500 units a day to accommodate the need of 40 area hospitals. Currently, it tests all donations for more than a dozen blood-borne diseases.
“We have so many testing processes in place that we don’t know yet if this will significantly impact costs or the costs will be negligible. We’ll find out once we complete out discussion with vendors.”
Safety, she said, is the watchword. “We are being proactive to protect the safety of recipients as well as our donors.”
While Zika is primarily spread through mosquito bites, there have been reports in Brazil of Zika transmission through transfusion.
No such cases have been reported in the United States.
One Zika-positive blood donation, though, was recently intercepted in Florida, Dr. Marks said Friday.
“The donation was identified while the blood bag was still in quarantine, before it was released,” he told reporters on a media call. “The system worked correctly.”
Zika can also be spread through sex, and Dr. Marks said that played into the decision to expand testing.
Adding to the challenge is that 4 out of 5 people infected never develop symptoms, such as fever, joint pain and rash.
The Centers for Disease Control and Prevention on Friday reported the first U.S. case of a man spreading Zika through sex even though he never had any symptoms. The Maryland man had traveled to the Dominican Republic, one of the many countries in the Caribbean and Latin America hit with a Zika outbreak.
There have been nearly 2,500 cases of Zika in the U.S. linked to travel to outbreak areas.
While the virus causes only a mild illness in most people, infection during pregnancy can lead to severe brain-related birth defects.
Blood testing began last month in parts of Florida after the first cases of homegrown Zika occurred in Miami. So far, there have been about 40 cases caused by mosquito bites in Florida.
The FDA has authorized use of two experimental blood screening tests for Zika, one made by Roche and another from Hologic Inc. and Grifols. Several testing sites are already voluntarily using the technology.
FDA officials said they do not anticipate any problems supplying the tests throughout the U.S., but an executive for America’s Blood Centers, which has more than 600 locations in the U.S. and Canada, warned that the amount of work needed to comply with the FDA’s timeline is “titanic.”
“Testing labs and the test vendors are working feverishly to allow testing to start on time in the areas subject to the 12-week timeline,” Dr. Louis Katz said in an email.
Friday’s announcement follows recent pressure from members of Congress to expand Zika screening. The move is “a strong step forward in protecting our nation’s blood supply,” Rep. Rosa DeLauro, D-Conn., said in a statement.