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FDA Approves Emergency Use Zika Test
March 21st, 2016
By Gary Evans, Senior Staff Writer
The Food and Drug Administration has given an emergency-use approval to a new Zika lab test that eliminates the need to also test for other mosquito-borne viruses to make a “rule-out” diagnosis. The assay allows clinicians to tell if a patient is infected with Zika, dengue or chikungunya instead of having to perform three separate tests to determine which virus is causing infection.
The Emergency Use Authorization (EUA) should allow more rapid testing to detect Zika infection, a critical determination in pregnant women at possible risk of the microcephaly birth defect linked to the virus. In response to a request from the Centers for Disease Control and Prevention, the FDA granted an EUA for the Trioplex Real-time RT-PCR Assay.
The CDC will begin distributing the test over the next two weeks to qualified laboratories in the Laboratory Response Network, an integrated network of domestic and international laboratories that respond to public health emergencies. The test will not be available in U.S. hospitals or other primary care settings.
As with any test, it is important that health care providers consult with their patients about test, the agencies remind.