FDA approves first test for screening Zika virus in blood do
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The USFDA has approved cobas Zika test, a qualitative nucleic acid test to detect Zika virus in blood donations in the US. The FDA issued a final guidance document recommending that all states and territories screen individual units of whole blood and blood components with an investigational blood screening test available under an investigational new drug (IND) application, or a licensed (approved) test when available.

The cobas Zika test is intended for use on the fully automated cobas 6800 and cobas 8800 systems. The cobas Zika test, cobas 6800, and cobas 8800 systems are manufactured by Roche Molecular Systems, Inc. The test’s clinical specificity was evaluated by testing individual samples from blood donations at five external laboratory sites, resulting in the clinical specificity of more than 99%...

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm579313.htm
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