The World Health Organization (WHO) has granted emergency use approval to the first diagnostic test for mpox (formerly monkeypox) under its Emergency Use Listing (EUL) procedure.
Manufactured by Abbott Molecular Inc., the Alinity m MPXV assay is expected to significantly enhance global diagnostic capacity, particularly in nations battling mpox outbreaks.
This approval is timely, as more than 30,000 suspected cases have been reported across Africa in 2024, with the Democratic Republic of the Congo, Burundi, and Nigeria experiencing the highest case numbers.
Despite the rising cases, Africa’s testing capacity remains limited.
The Alinity m MPXV assay, a real-time PCR test, detects monkeypox virus DNA from human skin lesion swabs, offering rapid and accurate results.
Early diagnosis is critical for timely treatment, care, and containment of the virus.
WHO’s EUL process accelerates the availability of life-saving tools like vaccines and tests in response to public health emergencies.
The emergency approval remains valid as long as the Public Health Emergency of International Concern (PHEIC) for mpox is in effect.
WHO is currently evaluating three more submissions and engaging with manufacturers to broaden diagnostic options.
