The World Health Organization (WHO) has made a significant stride in the global fight against mpox by listing the first mpox in vitro diagnostic (IVD) under its Emergency Use Listing (EUL) procedure. This move signifies a crucial advancement in increasing global access to accurate and timely mpox testing.
The WHO’s approval of the Alinity m MPXV assay, developed by Abbott Molecular Inc., is a pivotal moment in expanding diagnostic capabilities in countries battling mpox outbreaks. This real-time PCR test detects monkeypox virus (clade I/II) DNA from swabs taken from skin lesions, providing a rapid and reliable means to confirm suspected cases.
The Emergency Use Listing (EUL) procedure is designed to accelerate the availability of life-saving medical products, including vaccines, tests, and treatments, during Public Health Emergencies of International Concern (PHEIC). This process ensures that essential health products meet quality, safety, and performance standards, providing guidance to procurement agencies and WHO Member States for informed emergency procurement decisions.
The EUL for the Alinity m MPXV assay is a crucial step in addressing the urgent need for increased testing capacity in the face of the ongoing mpox outbreak. Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, highlighted the significance of this milestone, emphasizing that increasing access to quality-assured medical products is central to containing the virus and protecting populations, especially in underserved regions.
Early diagnosis of mpox is essential for timely treatment and care, helping to control the spread of the virus. Limited testing capacity and delays in confirming cases, particularly in Africa, have contributed to the virus’s continued spread. In 2024, over 30,000 suspected cases have been reported across the African continent, with the highest numbers in the Democratic Republic of the Congo, Burundi, and Nigeria.
The WHO’s initiative to expedite the availability of mpox diagnostics is a vital response to the global health emergency. The EUL for the Alinity m MPXV assay will remain valid as long as the Public Health Emergency of International Concern (PHEIC) justifying the emergency use of mpox in vitro diagnostics is in effect.
The WHO is actively engaged in discussions with other manufacturers of mpox IVDs to provide a broader range of quality-assured diagnostic options, further supporting countries in obtaining essential tests through UN agencies and other procurement partners. This collaborative effort aims to bolster global testing capabilities and equip countries with the tools necessary to effectively combat the spread of mpox.
