WHO Approves World's First Mpox Diagnostic Test For Emergency Use

Handling monkeypox in the Democratic Republic of Congo. (Twitter/@WHO)

JAKARTA - The World Health Organization (WHO) approved Abbott Laboratories' diagnostic test for emergency use on Thursday, the agency's first approval of increasing testing capabilities in countries facing the disease outbreak.

Real-time PCR tests, MPXV's Alinity m test, allow the DNA detection of mpox virus or monkeypox from human skin lesion swabs, the WHO said, adding the test was designed for use by trained clinical laboratory personnel.

"The first Mpox diagnostic test listed in the Emergency Use List (EUL) procedure is an important milestone in expanding the availability of testing in affected countries," Yukiko Nakaati, assistant director general of the agency for access to medicines and health products.

The agency said it was evaluating three new MPX diagnostic tests for emergency use and was also discussing with other manufacturers to expand the availability of the MPX diagnostic tool.

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

Separately, a Abbott spokesman said the company "currently has a MPPX Alinity m test in inventory and will work closely with customers to meet their testing needs".

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

Two MPX outlets are spreading, an endemic variant of clause I in parts of West and Central Africa, as well as a new, more contagious outlet, the Ib clause, which has sparked global concerns.

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