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FDA approves Zika test in qualified laboratory settings
The FDA issued an Emergency Use Authorization for a diagnostic test that can determine whether a patient is infected with chikungunya, dengue or Zika virus, according to the CDC.
The authorization, requested by the CDC, allows physicians to detect acute Zika virus infection more rapidly, as the assay distinguishes Zika from chikungunya and dengue in one test compared with three separate tests.
During the next 2 weeks, the Trioplex real-time reverse transcription PCR assay will be distributed to qualified laboratories in the Laboratory Response Network, a network of U.S. and international laboratories that respond to public health emergencies, according to a press release. The test is not approved for use in hospitals or other primary care settings in the United States.