Emergency Ebola test authorized for use

FDA issued an Emergency Use Authorization (EUA) for LightMix Ebola Zaire rRT-PCR Test for Ebola disease. The test can be used in West Africa and the United States.

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Manufactured by Roche Holdings AG, the LightMix Ebola Zaire Test runs on only specified instruments by CLIA High Complexity Laboratories or “similarly qualified” non-US laboratories. Based on the scientific data that FDA currently has, the test may be effective in diagnosing Ebola virus, according to FDA Commissioner Margaret A. Hamburg’s letter to Roche.

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In addition, there is no “adequate, approved and available alternative” to the emergency use of LightMix Ebola Zaire, according to Hamburg.

The assay is performed on nucleic acid, extracted either with the MagNA Pure 96 DNA and Viral Nucleic Acid Kit using the automated MagNA Pure 96 System or with the manual High Pure Viral Nucleic Acid Kit using the LightCycler 480 Instrument or cobas z 480 Analyzer with LIghtCycler Multiplex RNA Virus Master reagents for amplification and detection.

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In advertising and promotion, Roche must clearly state that the test has not been FDA approved; rather, it has been authorized for emergency use only, for the detection of RNA from Ebola Zaire Virus only, Hamburg said in the letter.