Essential medicines and health products

Diagnostics


In September 2014, WHO introduced an emergency procedure under its Prequalification Programme for rapid assessment of Ebola diagnostics for UN procurement to affected countries. The first diagnostic was accepted in November. In the same month, WHO called on manufacturers to develop rapid and easy to use point-of-care diagnostics that are better suited for use in the affected countries, where health infrastructure and trained personnel are largely lacking. The call was followed by a consultation, on 12 December 2014, where diagnostic experts and companies joined WHO and NGOs FIND and MSF to plan for accelerated development, production and deployment of adapted and rapid Ebola tests.

As a result, seven diagnostics have been approved for Emergency Use Assessment and Listing procedure (EUAL) by WHO:

  • OraQuick® Ebola Rapid Antigen Test Kit (Cadaveric Oral fluid and Whole Blood) manufactured by OraSure Technologies, Inc (listed in March 2016)
  • RealStar® Filovirus Screen RT-PCR Kit 1.0, developed by Altona Diagnostics GmbH (listed in November 2014);
  • Antigen Rapid Test Kit, ReEBOVTM, developed by Corgenix (listed in February 2015);
  • LiferiverTM Ebola Virus (EBOV) Real Time RT-PCR Kit, manufactured by Shanghai ZJ BioTech Co., Ltd., (listed in April 2015).
  • Xpert® Ebola Test manufactured by Cepheid AB - Solna, Sweden (listed in May 2015)
  • FilmArrayBiothreat-E, developed by BioFire Defence LLC., (listed in August 2015)
  • SD Q Line Ebola Zaire Ag, developed by SD Biosensor Inc., (listed in August 2015)