Zika blood test approved by FDA for screening donor blood
A blood test for detecting the Zika virus in donated blood has been approved by US regulators.
The Food and Drug Administration (FDA) gave the go ahead for the cobas Zika test, which detects Zika virus RNA, to prevent the virus “entering the US drug supply”.
It will be used to test plasma samples of whole blood and blood components from volunteer donors of, and also from, living organ donors.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said it was “the first approval of a Zika virus detection test for use with screening the nation’s blood supply”.
He added: “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 US and its territories.”
Zika is spread mostly by mosquitoes although it can also be contracted through blood transfusion and sexual contact.
Most people with the virus will show no symptoms, although it can cause fever, joint pain, maculopapular rash, and conjunctivitis.
But it can lead to a serious neurological disease in adults, and an infection with the Zika virus during pregnancy can cause serious birth defects.
Since August 2016, the FDA has recommended screening of donor blood products when tests became available and several states have already been using the cobas Zika test under an investigational new drug (IND) application scheme.
Results from this early use and manufacturer studies found the test had a clinical specificity of more than 99%, the FDA said.
The test is not designed or approved for diagnosing the viral infection in individuals.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20203704
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