WHO approves first mpox diagnostic test for emergency use

GENEVA -- The World Health Organization (WHO) said on Friday that it has approved the first diagnostic test for mpox, marking a significant milestone in expanding global access to mpox testing.

The approval comes as Africa continues to struggle with limited testing capacity, which fueled the spread of the virus. Over 30,000 suspected mpox cases have been reported across the continent in 2024, with the Democratic Republic of the Congo (DRC), Burundi, and Nigeria being the most affected.

In the DRC, only 37 percent of suspected cases have been tested this year, according to the global health agency.

The test, known as Alinity m MPXV assay, will boost diagnostic capacity in countries facing mpox outbreaks, where rapid and accurate testing is crucial.

The Alinity m MPXV assay is a real-time PCR test designed to detect mpox virus DNA from human skin lesion swabs, enabling laboratory and health workers to confirm cases quickly.

"This first mpox diagnostic test listed under the Emergency Use Listing procedure represents a significant milestone in expanding testing availability in affected countries," said Yukiko Nakatani, WHO's assistant director-general for access to medicines and health products.