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News From the Food and Drug Administration
October 3, 2017

New Tool to Aid Zika Diagnostics

JAMA. 2017;318(13):1214. doi:10.1001/jama.2017.13881

Diagnostic test manufacturers can now use human plasma samples to evaluate the accuracy of their tests to detect Zika virus infection.

The FDA has assembled a panel of samples from anonymous patients with Zika, West Nile, or dengue virus infection to help diagnostics manufacturers determine whether their tests can distinguish Zika from the other, similar pathogens—all flaviviruses. “This is part of our effort to ultimately bring these tests through the FDA’s formal review process to better ensure their reliability and to enable broader access to Zika diagnostic testing,” FDA Commissioner Scott Gottlieb, MD, said in a statement.

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