Switzerland-based Roche has obtained Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for LightMix Ebola Zaire rRT-PCR Test for use on patients with signs and symptoms of Ebola Zaire virus infection in conjunction with epidemiological risk factors such as individuals travelling from West Africa.
The test is said to be used to detect Ebola Zaire Virus in whole blood samples, with the help of large installed base of Roche’s LightCycler 480 or cobas z 480 instruments.
According to Roche, the test is a one-tube duplex assay for the simultaneous and qualitative detection of Ebola Zaire Virus and an endogenous human house-keeping gene used as an internal control.
Roche Diagnostics Division COO Roland Diggelman said: "The LightMix Ebola Zaire test is an easy-to-use molecular diagnostic test providing a solution for healthcare professionals to quickly detect the virus and start patient treatment as early as possible.
"As a leader in diagnostics, Roche is committed to providing testing solutions for the world’s most challenging healthcare
emergencies. The FDA’s granting of this EUA supports our commitment to healthcare professionals working to combat this deadly disease."
The test’s manufacturer TIB MOLBIOL also received CE mark approval for the LightMix Ebola Zaire rRT-PCR Test, as well as submitted an Expression of Interest (EOI) for Emergency Assessment by the World Health Organization Prequalification of the In vitro Diagnostics Programme.
Image: Electron micrograph of an Ebola virus virion. Photo: courtesy of CDC/Cynthia Goldsmith.