Thermo Fisher Scientific has secured emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its Zika virus assay.
The TaqPath Zika Virus Kit is currently authorised for diagnosis of infection by Zika virus and the qualitative detection of RNA from the virus in human serum and urine samples.
The assay can be applied to samples that are taken from people meeting Centres for Disease Control and Prevention (CDC) Zika virus clinical and/or epidemiological criteria.
TaqPath is available in a freeze-dried format and can support the surge capacity and deployment needs during an outbreak, while delivering results within two hours.
While an automated sample extraction can be performed with the King Fisher Flex system, the assay can be used alongside the QuantStudio Dx Real-Time PCR instrument.