QIAGEN recently announced it will offer global distribution of the RealStar Ebolavirus RT-PCR Kit.
The diagnostic kit, developed and manufactured by altona Diagnostics GmbH, 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.
QIAGEN agreed to distribute the tests after an existing Emergency Use Authorization (EUA) for the kits was modified on Nov. 26 by the U.S. Food and Drug Administration to permit authorized distribution and use in US and certain non-US laboratories.
The RealStar Ebolavirus kit is authorized 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. The EAU provides for use of the kit by CLIA High Complexity Laboratories and similarly qualified non-U.S. laboratories and only for the detection – not differentiation – of RNA from Ebolaviruses such as Zaire ebolavirus, including the Zaire ebolavirus strain detected in the West Africa outbreak 2014.
QIAGEN’s latest agreement with altona Diagnostics expands an existing collaboration between the two companies which was signed in the third quarter of 2014. Under this earlier agreement, QIAGEN is also distributing the RealStar Filovirus RT-PCR Kit, which does not fall under the EUA. This test is for both Ebola and Marburg and is CE-IVD marked for use on QIAGEN instruments and with QIAGEN sample technologies outside the United States.
Source: QIAGEN press release, adapted. RealStar is a registered, protected term of altona Diagnostics.
