FDA Issues EUA for Roche Ebola MDx Test

Monday, December 29, 2014

Source: Genome Web

The US Food and Drug Administration has issued an Emergency Use Authorization for Roche's LightMix Ebola Zaire rRT-PCR Test, a molecular diagnostic test for use by CLIA high-complexity laboratories or similarly qualified non-US labs.

The test is a real-time RT-PCR assay for the qualitative detection of Ebola virus RNA in human EDTA whole blood specimens from individuals with signs and symptoms of infection in conjunction with epidemiological risk factors.

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