The World Health Organization (WHO) has officially approved its first emergency use diagnostic test for mpox, developed by Abbott Laboratories, to bolster testing efforts in African countries grappling with outbreaks of the disease.
Named the Alinity m MPXV assay, this test utilizes real-time polymerase chain reaction (PCR) technology to identify mpox virus DNA from samples collected from human skin lesions. It is designed for use by trained clinical laboratory staff, facilitating swift and accurate detection of the virus, as highlighted by the WHO.
Yukiko Nakatani, the WHO’s assistant director-general for access to medicines and health products, remarked on the significance of this authorization, marking it as the first mpox diagnostic test to be included in the Emergency Use Listing (EUL). She described this development as a vital step in expanding testing resources in regions affected by the disease.
The EUL process allows for the expedited assessment of unlicensed vaccines, tests, and treatments during public health emergencies, enabling quicker access to crucial diagnostic tools. The WHO is also reviewing three additional mpox diagnostic tests for possible emergency use authorization and is engaging with other manufacturers to increase the availability of testing solutions.
Earlier this August, the WHO called for manufacturers to present their diagnostic products for emergency review, emphasizing the urgent need for effective testing strategies, particularly for vulnerable populations in low-income areas.
In August, mpox was declared a global public health emergency for the second consecutive year, following an outbreak in the Democratic Republic of the Congo that subsequently spread to neighboring nations such as Burundi, Uganda, and Rwanda. This WHO initiative aims to enhance testing capacities and improve the overall response to the disease across the continent.