WHO calls for urgent review of mpox tests amid surge

Congo emerges as the global epicenter of the epidemic, with over 16,000 reported cases and over 500 deaths

The World Health Organization has called for an emergency review of mpox testing in response to rising cases worldwide, with the Democratic Republic of the Congo (DRC) alone reporting 1000 more suspected cases this week.

Congo has emerged as the global epicenter of the epidemic, with over 16,000 reported cases and more than 500 deaths.

WHO has asked makers of mpox in vitro diagnostics (IVDs) to submit products for Emergency Use Listing (EUL).

In vitro diagnostics (IVDs) are tests that can detect disease, conditions and infections. In vitro means 'in glass', as these tests are typically conducted in test tubes and similar equipment, as opposed to in vivo tests, which are conducted in the body itself.

The Emergency Use Listing Procedure, on the other hand, assesses and lists unlicensed vaccines, therapeutics and in vitro diagnostics to expedite the availability of these products to people affected by a public health emergency.

Mpox, a viral disease characterized by a rash on the body, is caused by the monkeypox virus. It can be transmitted to humans through contact with an infected person, contaminated materials, or infected animals.

WHO said that through the EUL procedure, the world health body can approve medical products such as vaccines, tests and treatments for use.

“The process aims to assist countries, which have not approved the medical products through national approval processes, to procure the critically needed products such as tests through UN agencies and other partners,” WHO said.

The global health body called for expanding access to diagnostic services as tests are essential to critical measures such as strengthened laboratory capacity, improved case investigation, contact tracing, surveillance data collection, and timely reporting.

“As a package, these help countries identify chains of transmission, detect cases early, prevent further spread, and monitor the virus in real-time. The establishment of Emergency Use Listing procedures for mpox diagnostic tests will help advance towards this goal,” WHO said.

The UN agency said it is currently in talks with manufacturers about the need for effective diagnostics, particularly in low-income settings.

Since 2022, WHO has delivered around 150 000 diagnostic tests for mpox globally, of which over a quarter have gone to the countries in the African region, which has been hit the hardest by the spread of disease. In the coming weeks, WHO will deliver another 30 000 tests to the region.

In Congo, WHO has worked with partners to scale up diagnostic capacity to respond to the upsurge of cases. Since May, six additional labs have been equipped to diagnose mpox, enabling a decentralization of testing capacity from major cities to affected provinces.

Two of these labs are in South Kivu, selected to respond to the outbreak of the new viral strain, called Ib.

WHO has also updated its diagnostic testing guidance to detect the new virus strain and is working with countries to roll it out. Earlier, the agency issued target product profiles to guide manufacturers in the development of new diagnostic tests.

On August 14, WHO Director-General Dr Tedros Adhanom Ghebreyesus declared the upsurge of mpox in the DRC and in a growing number of countries in Africa, a public health emergency of international concern.