The revised guidance recommends that all states screen individual units of donated blood and blood components with a blood screening test authorized for use by FDA under an investigational new drug (IND) application, or a licensed test when available.
Advertisement
Last week, Pinellas County in Florida is using its solid waste and environmental program management department to identify areas of opportunity to protect citizens and visitors against the the virus.
The Red Cross also announced Friday it was conducting blood donor tests for Zika in five southeastern states, and would be expanding testing to four more states in the next two weeks.
The announcement comes amid growing concern in the United States about Zika, which when it infects pregnant women can cause a severe birth defect known as microcephaly, in which babies develop abnormally small skulls and brains.
“There is still much uncertainty regarding the nature and extent of Zika virus transmission”, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement. Samples will be sent for analysis to specially-certified USA laboratories with the appropriate equipment. But Marks said that only 1 percent of donations in Puerto Rico have tested positive for Zika virus.
The FDA grants this status to unapproved products whose use is deemed necessary in public health emergencies.
Uwe Oberlaender, Head of Roche Molecular Diagnostics, said, “The LightMix Zika test is an easy-to-use molecular diagnostic test that enables healthcare professionals to quickly detect the virus”.
SC had confirmed 43 cases of Zika related to travel as of Friday, according to the S.C. Department of Health and Environmental Control. There have been almost 2,500 cases of Zika in the USA linked to travel to outbreak areas and about 40 cases caused by mosquito bites in Florida.
Advertisement
In March, Roche won separate investigational approval from the FDA for its Cobas 6800/8800 testing system to be used to test blood at U.S. blood centres including in Puerto Rico, where about 1 percent of donated blood has so far tested positive for the virus.
