WHO Seeks Emergency Use Listing for Mpox Diagnostic Tests
The World Health Organization (WHO) has asked manufacturers of mpox in vitro diagnostics (IVDs) to submit expressions of interest for Emergency Use Listing (EUL). This move comes as the demand for diagnostic tests surges, with over 1,000 suspected cases reported in the Democratic Republic of the Congo alone this week.
Mpox, caused by the monkeypox virus, is a significant public health concern, particularly in low-income settings. Effective diagnostics are crucial for timely treatment and care, as well as preventing further spread. Since 2022, WHO has delivered over 150,000 diagnostic tests globally, with a quarter going to African countries. In the coming weeks, another 30,000 tests will be delivered to African countries.
In the Democratic Republic of the Congo, WHO has worked with partners to scale up diagnostic capacity, equipping six additional labs to diagnose mpox. This has led to a significant improvement in testing rates, with four times as many samples tested in 2024 compared to 2023.
WHO Director-General Dr. Tedros Adhanom Ghebreyesus declared the upsurge of mpox in the Democratic Republic of the Congo and several African countries a public health emergency of international concern (PHEIC) under the International Health Regulations (2005).
Manufacturers of IVDs are now asked to submit available quality, safety, and performance data to WHO. IVDs are tests done in laboratories to detect a pathogen, with detection of viral DNA by PCR (Polymerase Chain Reaction) testing being the gold standard for mpox diagnosis.
The EUL procedure allows WHO to approve medical products, such as vaccines, tests, and treatments, for use in emergency situations. This process aims to assist countries in procuring critically needed products, such as tests, through UN agencies and other partners.
Expanding access to diagnostic services is urgently needed, as tests are essential for critical measures such as strengthened laboratory capacity, improved case investigation, contact tracing, surveillance data collection, and timely reporting. The establishment of Emergency Use Listing procedures for mpox diagnostic tests will help advance towards this goal.
