WHO has accepted the first Ebola in vitro diagnostic for procurement by United Nations and other partners to Ebola affected countries. The product, RealStar® Filovirus Screen RT-PCR Kit 1.0 manufactured by Altona Diagnostics GmbH, was assessed under an emergency quality assessment mechanism established by WHO to address the lack of Ebola tests, and to fast-track countries’ access to reliable testing options.

“Quality diagnostics are vital if we are to contain and reverse the epidemic,” said Marie-Paule Kieny, WHO Assistant Director General for Health Systems and Innovation. “They allow medical staff to make important decisions about treatment, isolation and other considerations in order to care for patients suspected of being infected, and protect healthy people from exposure.”


A public report with additional details about the nature of the Emergency Quality Assessment Mechanism for RealStar® Filovirus Screen RT-PCR Kit 1.0.can be found at:



In response to the Ebola epidemic and public health emergency, WHO in September established a new emergency mechanism for quickly assessing the quality of Ebola-specific in-vitro diagnostic tests (IVDs). This emergency assessment procedure takes into consideration the special circumstances of this epidemic and the unique needs of the epidemic areas. Products that successfully meet the procedure’s requirements are eligible for procurement by UN agencies for one year, unless circumstances dictate otherwise, while further data on the performance characteristics of the test are developed.


This work is part of WHO’s multi-pronged approach to provide access to quality Ebola-specific IVDs. Given the challenging environmental conditions, lack of laboratory infrastructure, and lack of appropriately skilled staff, the development of simpler IVDs that may be used at point-of-care will be key to curbing the epidemic. WHO is working with the Forum for Innovative New Diagnostics (FIND), Médecins Sans Frontières (MSF), manufacturers and regulators to guide the development and validation of new tests that may be even better suited to the conditions facing patients and health care workers in West Africa.

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