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FDA Authorizes Use of PCR Test for Ebola Diagnosis

NEW YORK (GenomeWeb) – The US Food and Drug Administration has authorized the use of a PCR-based test for the diagnosis of the Ebola Zaire virus.

The test was developed by the US Department of Defense and uses Thermo Fisher Scientific Life Technologies' TaqMan technology. It is authorized by FDA for use in laboratories "designated by DoD to help facilitate effective responses to the ongoing Ebola outbreak detected in West Africa," a spokesperson for the FDA said in an email to GenomeWeb Daily News.

The virus has swept through primarily Liberia, Sierra Leone, and Guinea where it has been blamed for more than 900 deaths. In the US, concerns about the virus have been raised amid reports of isolated cases of patients being admitted to hospitals with symptoms similar to those of ebola, though it is unclear whether the patients actually have the virus.

The DoD test is not FDA approved, but by law FDA can issue an Emergency Use Authorization for such products during emergencies, "when among other circumstances, there are not adequate, approved, and available alternatives," the FDA spokesperson said.

The test is specifically "intended for use in individuals with signs and symptoms of infection with Ebola Zaire virus, who are at risk for exposure to the virus, or who may have been exposed to the virus," she added.

The Ebola Zaire strain of the virus is especially deadly with a fatality rate of greater than 80 percent.

The DoD test is a real-time reverse transcriptase PCR-based assay for the in vitro qualitative detection of Ebola Zaire virus in Trizol-inactivated whole blood or Trizol-inactivated plasma specimens. It consists of nucleic acid extraction followed by rRT-PCR on the ABI 7500 Fast Dx instrument, the JBAIDS instrument from BioFire Defense, or the Roche LightCycler instrument.

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