WHO approves first mpox diagnostic test for emergency use

GENEVA — The World Health Organization has authorized Abbott Laboratories' mpox diagnostic test for emergency use, the first such approval in the agency's effort to bolster testing capabilities in countries facing outbreaks of the disease.

The real-time PCR test, Alinity m MPXV assay, enables detection of mpox virus DNA from human skin lesion swabs, the WHO said, adding that it was designed for use by trained clinical laboratory personnel.

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

An Abbott spokesperson said that the company "currently has the Alinity m mpox test in inventory and will work with customers on their testing needs".

The agency said it was evaluating three new mpox diagnostic tests for emergency use and was also in discussions with other manufacturers to expand the availability of mpox diagnostic tools.

In August, WHO asked manufacturers to submit their products for an emergency review. The EUL procedure is a risk-based assessment of unlicensed vaccines, tests and treatments to expedite their availability during public health emergencies.

The WHO declared mpox a global public health emergency for the second time in two years in August, following an outbreak of the viral infection in the Democratic Republic of Congo, which has spread to neighbouring Burundi, Uganda and Rwanda.

Two strains of mpox are spreading - the clade I variant, which is endemic in parts of West and Central Africa and a new, more transmissible strain clade Ib, which has triggered global concern.

Sweden, Thailand, and India have confirmed cases of the clade Ib type of the virus, outside of the Democratic Republic of Congo and neighboring countries.

© Thomson Reuters 2024.