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 request marks a critical step in ongoing discussions between WHO and diagnostic manufacturers about the need for effective testing, especially in low-income settings.
Testing is essential for early detection, treatment, and preventing the further spread of mpox.
Since 2022, WHO has distributed approximately 150,000 mpox diagnostic tests worldwide, with over a quarter directed to countries in the African Region. In the coming weeks, WHO plans to deliver an additional 30,000 tests to African nations.
The demand for diagnostic tests is surging, particularly in the Democratic Republic of the Congo (DRC), where up to 1,000 suspected cases were reported this week alone. WHO, in collaboration with partners, has ramped up diagnostic capacity in the DRC to address the rise in cases.
Since May 2024, six new laboratories have been equipped to diagnose mpox, decentralizing testing from major cities to affected provinces. Notably, two of these labs in South Kivu were established to address the outbreak of a new viral strain, referred to as strain Ib.
These efforts have significantly improved testing rates, with four times more samples tested in 2024 compared to 2023.WHO has also updated its diagnostic testing guidance to detect this new strain and is working with countries to implement it. Additionally, WHO has issued target product profiles to assist manufacturers in developing new diagnostic tests.
On 14 August 2024, WHO Director-General Dr. Tedros Adhanom Ghebreyesus declared the mpox outbreak in the DRC and other affected African countries a Public Health Emergency of International Concern (PHEIC) under the International Health Regulations (2005).
Manufacturers of IVDs are urged to submit available quality, safety, and performance data to WHO promptly. IVDs are laboratory tests used to detect pathogens, with PCR (Polymerase Chain Reaction) testing being the gold standard for mpox diagnosis. PCR tests detect viral DNA in samples taken from skin lesions, such as fluid or crusts from vesicles or pustules.
Blood testing is not recommended for routine diagnosis, and antibody detection methods are used only for retrospective case classification, not for diagnosis.
Through the EUL process, WHO can approve medical products, such as vaccines, tests, and treatments, for emergency use, facilitating the procurement of these essential products by countries that have not yet approved them through national processes.
Mpox, caused by the monkeypox virus, a species of the Orthopoxvirus genus, can be transmitted to humans through contact with infected individuals, contaminated materials, or animals.
Expanding access to diagnostic services is crucial for strengthening laboratory capacity, improving case investigations, contact tracing, data collection, and timely reporting. These measures help countries identify transmission chains, detect cases early, prevent further spread, and monitor the virus in real-time.
The establishment of EUL procedures for mpox diagnostic tests will support these efforts.
