 "FDA recommends Zika testing for all blood donated in US")
The US Food and Drug Administration recommended on Friday that all blood donated in the United States and its territories be tested for Zika virus, as it moves to prevent transmission of the virus through the blood supply.
The agency said its decision to expand blood screening in the United States was based on concerns about more cases of local transmission in Florida, the growing number of travel-related infections and concerns that Zika-tainted blood could unwittingly be given to a pregnant woman, putting her unborn baby at risk of severe birth defects.
"The transfusion of a pregnant woman with blood infected with the Zika virus could have terrible consequences," Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said during a conference call with reporters.
"Over 8,000 travel associated and over 2,000 non-travel associated cases of Zika have been reported in the United States and US territories," Marks told reporters.
Given frequency of travel of individuals within the United States, he said there was a risk that people without symptoms of Zika could donate blood and transmit the virus.
Testing of donated blood is underway in Florida, Puerto Rico, as well as in other areas of the United States, and has been proven helpful in finding infected donations.
"About 1 per cent of donations in Puerto Rico have tested positive for Zika virus," Marks said.
Such testing also helped spot one unit of Zika-tainted blood in the past few weeks. Marks said testing discovered the infected blood before it reached any patients.
The Food and Drug Administration plans to roll out its recommendations in stages. In states and territories with local, mosquito-borne transmission, the recommendations will go into effect immediately. This affects Florida and Puerto Rico.
In 11 states near areas with local transmission or high rates of travel-related infections, the guidelines must be implemented within four weeks. These states include Alabama, Arizona, California, Georgia, Hawaii, Louisiana, Mississippi, New Mexico, New York, South Carolina and Texas.
For the rest of country, the guidelines must be implemented within 12 weeks.
Marks said Hologic Inc and Roche Molecular Systems had been granted special approval for their tests to be used to screen the blood supply.
Marks said the FDA had already reviewed data submitted by the companies and was confident these investigational tests would "perform appropriately" in this setting.
In addition to tests to check whole blood for Zika RNA, the agency said blood collection centres were permitted to use Cerus's Intercept pathogen inactivation system in certain blood products, such as plasma.
America's Blood Centres, a network of 63 blood centres with 600 donation sites in 45 US states, is currently testing for Zika primarily in Florida, where local transmission has been reported. It also has centres testing in areas of Texas that are considered at high risk for the spread of the virus, and an affiliate in Arizona testing high-risk donors.
Louis Katz, chief medical officer for America's Blood Centres, said it would take a "titanic" effort to implement testing in the first-tier states expected to be online in four weeks, but stressed the organisation's commitment to a safe blood supply.
"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," he said in an email. "My conversations with the vendors suggest that if all goes smoothly that goal is feasible. Then, whether things go smoothly in an incredibly complex set of processes becomes critical." In March, the FDA granted Roche approval for a clinical trial testing its Zika blood screening test in Puerto Rico, where local blood donations had been halted and blood had to be imported from the continental United States.
The agency said its decision to expand blood screening in the United States was based on concerns about more cases of local transmission in Florida, the growing number of travel-related infections and concerns that Zika-tainted blood could unwittingly be given to a pregnant woman, putting her unborn baby at risk of severe birth defects.
"The transfusion of a pregnant woman with blood infected with the Zika virus could have terrible consequences," Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said during a conference call with reporters.
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The current Zika outbreak was first detected in Brazil last year and has since spread across the Americas. In Brazil, Zika has been linked to more than 1,800 cases of microcephaly, and US officials expect as many as 270 cases in Puerto Rico, where local transmission of the virus is widespread.
"Over 8,000 travel associated and over 2,000 non-travel associated cases of Zika have been reported in the United States and US territories," Marks told reporters.
Given frequency of travel of individuals within the United States, he said there was a risk that people without symptoms of Zika could donate blood and transmit the virus.
Testing of donated blood is underway in Florida, Puerto Rico, as well as in other areas of the United States, and has been proven helpful in finding infected donations.
"About 1 per cent of donations in Puerto Rico have tested positive for Zika virus," Marks said.
Such testing also helped spot one unit of Zika-tainted blood in the past few weeks. Marks said testing discovered the infected blood before it reached any patients.
The Food and Drug Administration plans to roll out its recommendations in stages. In states and territories with local, mosquito-borne transmission, the recommendations will go into effect immediately. This affects Florida and Puerto Rico.
In 11 states near areas with local transmission or high rates of travel-related infections, the guidelines must be implemented within four weeks. These states include Alabama, Arizona, California, Georgia, Hawaii, Louisiana, Mississippi, New Mexico, New York, South Carolina and Texas.
For the rest of country, the guidelines must be implemented within 12 weeks.
Marks said Hologic Inc and Roche Molecular Systems had been granted special approval for their tests to be used to screen the blood supply.
Marks said the FDA had already reviewed data submitted by the companies and was confident these investigational tests would "perform appropriately" in this setting.
In addition to tests to check whole blood for Zika RNA, the agency said blood collection centres were permitted to use Cerus's Intercept pathogen inactivation system in certain blood products, such as plasma.
America's Blood Centres, a network of 63 blood centres with 600 donation sites in 45 US states, is currently testing for Zika primarily in Florida, where local transmission has been reported. It also has centres testing in areas of Texas that are considered at high risk for the spread of the virus, and an affiliate in Arizona testing high-risk donors.
Louis Katz, chief medical officer for America's Blood Centres, said it would take a "titanic" effort to implement testing in the first-tier states expected to be online in four weeks, but stressed the organisation's commitment to a safe blood supply.
"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," he said in an email. "My conversations with the vendors suggest that if all goes smoothly that goal is feasible. Then, whether things go smoothly in an incredibly complex set of processes becomes critical." In March, the FDA granted Roche approval for a clinical trial testing its Zika blood screening test in Puerto Rico, where local blood donations had been halted and blood had to be imported from the continental United States.