WHO calls for rapid access to diagnostic tests for mpox, urges manufacturers to urgently check

The WHO has asked the manufacturer of mpox in vitro diagnostics (IVD) submit an expression of interest for the emergency use list (EUL). WHO is in ongoing discussions with manufacturers about the need for effective diagnostics, particularly in low-income settings. The request for an EUL Expression of Interest from manufacturers is the latest development in these discussions.

Testing is essential for people to get treatment and care as early as possible and prevent further spread. As of 2022, WHO has delivered about 150,000 mpox diagnostic tests globally, of which more than a quarter went to countries in the African region. In the coming weeks, WHO will deliver another 30,000 tests to African countries.

With as many as 1,000 suspected cases reported in the Democratic Republic of Congo alone this week, demand for diagnostic tests is on the rise. In this hard-hit country, WHO has been working with partners to increase diagnostic capacity to respond to the surge in cases. As of May 2024, six additional laboratories have been equipped to diagnose mpox, enabling the decentralization of testing capacity from major cities to affected provinces. Two of these laboratories are located in South Kivu, chosen to respond to the outbreak of the new virus strain, called Ib. Thanks to these efforts, testing rates have improved dramatically in the country, with four times as many samples tested in 2024 so far compared to 2023.

The WHO has also updated its guidelines for diagnostic testing to discover a new strain of the virus and works with countries to introduce it. Earlier, WHO issued target product profiles guide manufacturers in the development of new diagnostic tests.

WHO Director-General Dr. Tedros Adhanom Ghebreyesus stated on August 14, 2024 that the increase in measles in the Democratic Republic of Congo (DRC) and in a growing number of countries in Africa constitutes a Public Health Emergency of International Concern (PHEIC) according to the International Health Regulations (2005). .

IVD manufacturers are now required to provide WHO with available data on quality, safety and efficacy as soon as possible. IVDs are tests done in laboratories to detect pathogens. Detection of viral DNA by PCR (polymerase chain reaction) testing is the gold standard for the diagnosis of mpox. It detects virus DNA in samples taken from skin lesions, such as fluid or scab from vesicles or pustules. Blood testing is not recommended for routine diagnosis, and antibody detection methods can be used for retrospective case classification but not for diagnosis.

Through the EUL procedure, WHO can approve medical products such as vaccines, tests and treatments for use, evaluating the acceptability of use of certain products for time-limited procurement in emergency situations. The process aims to help countries that have not approved medical products through national approval processes to procure critically needed products such as tests through UN agencies and other partners.

Mpox is a disease caused by the monkeypox virus, a species of the genus Orthopoxviruswhich can be transmitted to humans through contact with someone who is contagious, with contaminated materials, or with infected animals.

There is an urgent need to expand access to diagnostic services as the tests are critical to key measures such as strengthened laboratory capacity, improved case investigation, contact tracing, surveillance data collection and timely reporting. As a package, they help countries identify transmission chains, detect cases early, prevent further spread and monitor the virus in real time. Establishing emergency use list procedures for mpox diagnostic tests will help advance this goal.