altona Diagnostic RealStar Ebolavirus RT-PCR Kit 1.0

The altona Diagnostics RealStar Ebolavirus RT-PCR Kit 1.0 is a reverse transcription polymerase chain reaction (RT-PCR) test intended for the qualitative detection of RNA from all known strains of ebolaviruses, including the Zaire strain driving the current Ebola epidemic in West Africa. The kit is authorised for emergency use on specified instruments in plasma from individuals with signs and symptoms of Ebolavirus infection in conjunction with clinical and epidemiological risk factors.

It has been authorised by the FDA under an Emergency Use Authorization for use by CLIA High Complexity Laboratories and similarly qualified non-US laboratories and only for the detection - not differentiation - of RNA from ebolaviruses (such as Zaire ebolavirus, Sudan ebolavirus, Tai Forest ebolavirus, Bundibugyo ebolavirus and Reston ebolavirus) and not for any other viruses or pathogens. The test is only authorised for the duration of the declaration that circumstances exist justifying the authorisation of the emergency use of in vitro diagnostics for detection of Zaire ebolavirus.