WHO urges rapid access to mpox tests amid rising demand

The World Health Organization (WHO) has urged manufacturers of mpox in vitro diagnostics (IVDs) to submit expressions of interest for Emergency Use Listing (EUL) to address the growing need for effective diagnostics, particularly in low-income regions.

This call comes as part of ongoing discussions between WHO and manufacturers about expanding access to diagnostic tests.

Testing is crucial for early treatment, care, and preventing further spread of mpox.

Since 2022, WHO has distributed around 150,000 diagnostic tests globally, with over a quarter allocated to African nations.

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Additional 30,000 tests are expected to be delivered to African countries in the coming weeks.

The Democratic Republic of the Congo (DRC), reporting nearly 1,000 suspected cases in a single week, exemplifies the urgent need for diagnostic tests.

WHO, in partnership with local stakeholders, has expanded the country’s testing capacity, equipping six additional labs since May 2024.

This decentralization of testing from major cities to provinces, including South Kivu, has significantly increased testing rates, with four times more samples processed in 2024 compared to 2023.

In response to the outbreak of a new viral strain, Ib, WHO has updated its diagnostic testing guidance and is working with countries to implement these changes.

Manufacturers are encouraged to submit data on the quality, safety, and performance of their IVDs to WHO promptly.

The WHO Director-General, Dr. Tedros Adhanom Ghebreyesus, declared on August 14, 2024, that the surge in mpox cases in the DRC and other African nations constitutes a Public Health Emergency of International Concern (PHEIC) under the International Health Regulations (2005).

Through the EUL process, WHO can authorize the use of medical products, including diagnostic tests, in emergencies, assisting countries that lack national approval procedures to procure essential items through UN agencies and other partners.

Mpox, caused by the monkeypox virus, is transmitted through contact with infected individuals, contaminated materials, or animals.

Expanding diagnostic services is vital for measures such as improved laboratory capacity, case investigation, contact tracing, surveillance, and timely reporting, all of which are essential for managing the virus and preventing further transmission.

WHO’s establishment of EUL procedures for mpox diagnostic tests aims to bolster these efforts and enhance global response to the outbreak.