2 additional tests listed under the EUL for IVDs

The RealStar Filovirus Screen RT-PCR Kit 1.0, manufactured by Diagnostics GmbH, and the RADIONE Ebola/Marburg Detection Kit, manufactured by KH Medical Co., Ltd., have now received WHO Emergency Use Listing (EUL), becoming the second and the third WHO EUL-listed diagnostic option under the current Bundibugyo Ebola emergency pathway and further strengthening access to quality-assured outbreak diagnostics.

The RealStar Filovirus Screen RT-PCR Kit 1.0 is an in vitro diagnostic test, based
on real-time PCR technology, for the qualitative detection and differentiation of
Ebola- and Marburg virus-specific RNA in human EDTA plasma.

The RADIONE Ebola/Marburg Detection Kit is a real-time PCR assay. The test runs on the RADIONE integrated near point-of-care platform, combining extraction, amplification, and analysis in a closed system and delivering results in approximately 65 minutes. 

Both assays detect Zaire, Sudan, Bundibugyo, Taï Forest, and Reston ebolaviruses and report them collectively as Ebola Positive/detected, without differentiation among individual Ebola virus species. Marburg virus is reported separately.

Please note that the focus of the EUL assessment is the assay's performance related to BDBV detection, and then the ability to detect Marburg disease is not covered under the current EUL listing.