QIAGEN has announced that it will offer global distribution of the altona Diagnostics RealStar Ebolavirus RT-PCR Kit 1.0. On November 26, the United States Food and Drug Administration (FDA) amended an Emergency Use Authorization (EUA) originally issued on November 10, 2014, to permit authorized distribution and use of this kit in the U.S. and certain non-U.S. laboratories. 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 has agreed to distribute the RealStar Ebolavirus RT-PCR Kit 1.0 in addition to 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 EUA.
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. As authorized by the FDA under EUA, the test has not been FDA cleared or approved. It has been authorized by the FDA under an Emergency Use Authorization for use 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, Sudan Ebolavirus, Tai Forest Ebolavirus, Bundibugyo Ebolavirus, and Reston Ebolavirus) and not for any other viruses or pathogens. Furthermore, this test is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection of Ebola Zaire virus under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
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