Rapid communication on the role of the GeneXpert® platform for rapid molecular testing for SARS-CoV-2 in the WHO European Region

Overview

In view of the current COVID-19 pandemic and consequent need for automated rapid diagnostic technologies with a rapid turnaround time, the European Laboratory Initiative on TB, HIV and Viral Hepatitis (‎ELI)‎ has developed this rapid communication to inform Member States of the WHO European Region on the potential use of the Xpert® Xpress SARS-CoV-2 cartridge (‎Cepheid, Sunnyvale, United States of America)‎. These cartridges, which received Emergency Use Authorization from the United States Food and Drug Administration on 20 March 2020, can be run on GeneXpert® platforms that are already available in the Region and currently used for diagnosis of tuberculosis and rifampicin resistance (‎as recommended by WHO)‎, hepatitis C and seasonal influenza, and for HIV viral load testing and early infant diagnosis of HIV infection. Based on the best available evidence and current knowledge, this rapid communication by ELI provides a short overview of (‎i)‎ the major points when considering the use of GeneXpert® machines for COVID-19 testing and (‎ii)‎ the support that ELI is working to provide to Member States of the Region.