WHO Calls for Urgent Access to Mpox Diagnostic Tests, Invites Manufacturers for Emergency Review
The World Health Organization (WHO) has urgently requested manufacturers to submit expressions of interest for Emergency Use Listing (EUL) of mpox diagnostic tests, highlighting the critical need for effective diagnostics amid the current outbreak. Mpox, caused by the monkeypox virus, poses a significant public health challenge, especially in low-income regions where access to testing is limited.
In a statement released on Thursday, WHO emphasized the importance of timely testing to facilitate early treatment and prevent further spread of the disease. Since 2022, the organization has distributed approximately 150,000 diagnostic tests globally, with over a quarter allocated to countries in Africa. An additional 30,000 tests are set to be delivered to African nations in the coming weeks.
The demand for diagnostic tests has surged, particularly in the Democratic Republic of the Congo (DRC), where nearly 1,000 suspected cases have been reported in the past week. To address this, WHO has expanded diagnostic capacity by equipping six new labs, including two in South Kivu to tackle a new viral strain known as Ib. This expansion has significantly increased testing rates in the DRC.
WHO has updated its diagnostic guidelines to detect this new strain and is collaborating with countries to implement these changes. Manufacturers are now being asked to provide data on the quality, safety, and performance of their diagnostic tests. The gold standard for mpox diagnosis remains PCR (Polymerase Chain Reaction) testing, which detects the virus’s DNA from samples taken from skin lesions. Blood tests and antibody detection methods are not recommended for routine diagnosis.
The EUL procedure allows WHO to approve medical products for emergency use, facilitating procurement in situations where national approval processes may be delayed. This procedure aims to help countries access necessary diagnostics through UN agencies and other partners.
Expanding diagnostic access is crucial for enhancing laboratory capacity, improving case investigation, and monitoring the virus in real-time. WHO’s efforts to establish EUL procedures for mpox diagnostic tests are a critical step toward managing the outbreak and preventing further transmission.