The World Health Organization (WHO) has called on manufacturers of mpox in vitro diagnostics (IVDs) to submit expressions of interest for Emergency Use Listing (EUL). This move follows ongoing discussions with manufacturers about the critical need for effective diagnostics, especially in low-income regions. The EUL request represents the latest effort to enhance diagnostic capabilities amid rising mpox cases.
Testing is essential for timely treatment and controlling the spread of mpox. Since 2022, WHO has distributed approximately 150,000 mpox diagnostic tests globally, with over a quarter allocated to the African Region. An additional 30,000 tests are scheduled for delivery to African countries in the coming weeks.
The Democratic Republic of the Congo (DRC) has reported up to 1,000 suspected cases of mpox this week, highlighting the urgent need for diagnostic resources. In response, WHO has collaborated with partners to increase diagnostic capacity in the DRC. Since May 2024, six new laboratories have been equipped to diagnose mpox, expanding testing capabilities beyond major cities to affected provinces. Two of these labs are in South Kivu, specifically addressing the outbreak of the new viral strain, Ib. These efforts have led to a fourfold increase in testing rates in the DRC compared to 2023.
WHO has updated its diagnostic testing guidance to include detection of the new virus strain and is supporting countries in implementing these guidelines. Earlier, WHO issued target product profiles to guide the development of new diagnostic tests.
WHO Director-General Dr. Tedros Adhanom Ghebreyesus declared a public health emergency of international concern (PHEIC) on August 14, 2024, due to the mpox surge. Manufacturers are now urged to submit quality, safety, and performance data for their diagnostic tests. The EUL procedure will enable rapid procurement of critical diagnostic tools through UN agencies and other partners, facilitating improved case detection, monitoring, and control measures.
