The cobas Zika test has been approved by the U.S. Food and Drug Administration — the first approved screening test to detect the Zika virus in blood donations.
The test is not designed to diagnose any particular person’s Zika infection, however, the FDA said.
In August 2016, the agency recommended that all U.S. states and territories screen blood for Zika, according to an FDA media release.
“Screening blood donations for the Zika virus is critical to preventing infected donations from entering the U.S. blood supply,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
Some blood-collection centers had already been using the cobas test in order to comply with the 2016 edict. Data collected from this testing, in tandem with additional information provided by the test’s manufacturer, were used to approve the diagnostic, the FDA said. The test has proven about 99 percent accurate.
Zika is spread primarily via the bite of an infected mosquito, but it may also be transmitted by blood transfusion or sexual contact. Most people infected don’t develop symptoms, but an infection during pregnancy can cause devastating birth defects.
The cobas test is produced by Roche Molecular Systems, based in Pleasanton, Calif.
The FDA has more about this approval.
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