January 2015—Qiagen will offer global distribution of the RealStar Ebolavirus RT-PCR Kit 1.0. The diagnostic kit, developed and manufactured by Altona Diagnostics, is a reverse transcription polymerase chain reaction test intended for the qualitative detection of RNA from all known strains of Ebola viruses. Qiagen will distribute the kit and Altona’s already CE-IVD marked test, the RealStar Filovirus RT-PCR Kit, which is for both Ebola and Marburg viruses and does not fall under the emergency use authorization.
The RealStar Ebolavirus kit is authorized for emergency use on specified instruments in plasma from individuals with signs and symptoms of Ebola virus infection in conjunction with clinical and epidemiological risk factors. Under the EUA, the test is for use by CLIA high-complexity laboratories and similarly qualified non-U.S. laboratories and only for the detection, not differentiation, of RNA from Ebola viruses (such as Zaire Ebola virus, Sudan Ebola virus, Tai Forest Ebola virus, Bundibugyo Ebola virus, and Reston Ebola virus). The test has not been FDA cleared or approved.
Qiagen, 240-686-7425