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FDA approves first test to screen donor blood supply for Zika
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The FDA recently approved the cobas Zika test, a nucleic acid test intended for use by blood collection establishments in the United States to screen blood donations for Zika virus and reduce the risk of contaminated blood.
Although not designed for individual diagnosis of Zika virus infection, the cobas Zika test (NAT, Roche Molecular Systems) is approved to screen for Zika virus RNA in individual plasma specimens obtained from volunteer donors of whole blood and blood components, as well as from living organ donors.
“Today’s action represents the first approval of a Zika virus detection test for use with screening the nation’s blood supply,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “Screening blood donations for the Zika virus is critical to preventing infected donations from entering the U.S. blood supply.”
In June 2016, the cobas Zika test — authorized by the FDA under an investigational new drug — was deployed for screening of the donor blood supply in Puerto Rico and in the Houston area to preserve the safety of local blood supplies in areas experiencing active Zika transmission.
Two months later, the FDA expanded its prior guidance for Zika virus testing that all donations acquired in the U.S. and its territories be screened using a licensed test, or one authorized for use by the FDA under an investigational new drug application.
Before the current approval, several blood collection institutions had used the cobas Zika test under the investigational new drug protocol in order to adhere to these recommendations. According to data collected from this testing, as well as supplementary studies performed by the manufacturer, the cobas Zika test effectively screened blood donors for Zika virus infection, with a clinical specificity of more than 99%.
“Today’s approval is the result of a commitment by the manufacturer to work rapidly and collaboratively with the FDA and the blood collection industry to respond to a public health crisis and ensure the safety of blood in the U.S. and its territories,” Marks said in the release.
Disclosure: Marks reported no relevant financial disclosures.