FDA has granted Siemens Healthineers an emergency use authorization (EUA) for its real-time polymerase chain reaction Zika virus assay, the Versant Zika RNA 1.0 assay (kPCR) kit.
The kit is capable of detecting the presence of Zika virus, which can be an earlier indicator of Zika virus infection than anti-Zika antibodies. The molecular test is validated for plasma, serum, and urine (collected alongside a patient-matched serum or plasma specimen) from individuals meeting Zika virus clinical criteria or Zika virus epidemiological criteria from the US Centers for Disease Control and Prevention.
“FDA’s emergency use authorization of the Versant Zika RNA 1.0 assay (kPCR) kit from Siemens can lead us one step closer to stopping the spread of the Zika virus,” says Fernando Beils, vice president and head of molecular diagnostics at Siemens. “Being able to quickly diagnose patients will help physicians to more efficiently manage those affected.”
The kit is designed to run on the Siemens Versant kPCR sample prep automated platform, along with several commercially available thermal cyclers. The assay must be run by laboratories in the United States that are certified under the Clinical Laboratory Improvement Amendments of 1988 to perform high-complexity tests, or by similarly qualified non-US laboratories. The kit has not been FDA cleared or approved and is only authorized for use for the duration of the emergency use declaration.
For more information, read FDA’s EUA.