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FDA Grants Altona Dx Emergency Use Authorization for RealStar Ebolavirus PCR Kit

NEW YORK (GenomeWeb) – The US Food and Drug Administration has issued an Emergency Use Authorization for Altona Diagnostics' RealStar Ebolavirus RT-PCR Kit 1.0, a first-line molecular diagnostic test for use only by CLIA high-complexity laboratories.

The test is a RT-PCR assay for the in vitro qualitative detection of Ebola virus RNA in human EDTA plasma specimens from individuals with signs and symptoms of infection in conjunction with epidemiological risk factors. RNA is extracted from whole blood collected with EDTA as the anticoagulant using Qiagen's QiaAmp Viral RNA Mini Kit. The diagnostic contains three processes in a single tube assay: reverse transcription of the target RNA, PCR amplification, and simultaneous detection of PCR amplicons by fluorescent dye labeled probes.

The assay can be used with the Thermo Fisher Scientific's ABI Prism 7500 SDS and 7500 Fast SDS instruments, the Roche Light Cycler 480 Instrument II, and the Bio-Rad CFX96 system/Dx real-time system.

Altona noted in a statement that the test's performance was verified in collaboration with the German National Reference Centre for tropical pathogens at the Bernhard Nocht Institute for Tropical Medicine in Hamburg, Germany.

The FDA noted that it had waived current good manufacturing practice and labeling requirements for the test as long as the EUA is in effect.

In a letter, FDA Commissioner Margaret Hamburg said that the current threat of Ebola, along with evidence that the test can effectively diagnose infection, justified the authorization of emergency use of in vitro diagnostics for detecting the virus.

Several firms and federal labs have sought emergency use authorization from the FDA for their Ebola molecular diagnostic tests. The US Department of Defense's EZ1 test received the first EUA for Ebola testing on Aug. 6, and BioFire Defense received EUAs for two FilmArray Ebola tests in October.

Hamburg, Germany-based Altona's RealStar Filovirus Screen Kit, which also detects Marburg virus and other filoviruses, is currently being used in the European Mobile Laboratory in West Africa. The firm also offers the second-line RealStar Filovirus Type assay, which identifies and differentiates between the five Ebola viruses and Marburgvirus.

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