altona Diagnostics Receives Emergency Use Authorization for Zika Virus Diagnostic Test

On May 13th, altona Diagnostics received Emergency Use Authorization (EUA) from the FDA for their RealStar Zika Virus RT-PCR Kit U.S. for the qualitative detection of RNA from Zika virus in serum or urine (collected alongside a patient-matched serum specimen) from individuals meeting CDC Zika virus clinical criteria. This is the same kit that Houston Methodist Hospital and Texas Children’s Hospital used for their laboratory-developed Zika test.

FDA Letter of Authorization

altona Diagnostics press release

 

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