WHO Approves Ebola Assay
News May 15, 2015
The World Health Organization has added Cepheid's Xpert Ebola assay to its list of Ebola diagnostics eligible for WHO procurement, Cepheid said today.
Cepheid's Ebola test runs on its GeneXpert system, of which more than 8,000 are currently deployed globally. The assay uses RT-qPCR and, like all of Cepheid's molecular diagnostic tests, is cartridge-based, making it less prone to contamination and better suited for staff with minimal formal laboratory training, WHO noted in a statement.
Xpert Ebola joins three other tests on WHO's list of in vitro diagnostics eligible for procurement in Ebola-affected countries: Shanghai ZJ Bio-Tech's Liferiver Ebola kit and Altona Diagnostics' RealStar Filovirus Screen kit, both also RT-qPCR tests; and a rapid antigen test kit called ReEBOV.
In March, Cepheid's Xpert Ebola test received Emergency Use Authorization from the US Food and Drug Administration for use by CLIA moderate- and high-complexity laboratories or similarly qualified non-US laboratories.