WHO authorise Abbott Molecular’s mpox diagnostic test, Alinity m MPXV assay for emergency use

The World Health Organization (WHO) has added the first in vitro diagnostic (IVD) test for mpox to its Emergency Use Listing (EUL), enhancing global testing access. The Alinity m MPXV assay from Abbott Molecular Inc. has received emergency approval, crucial for increasing diagnostic capabilities in countries facing mpox outbreaks where rapid testing is essential.

In Africa, limited testing capacity and delays in confirming cases persist, with over 30,000 suspected cases reported in 2024, particularly in the Democratic Republic of the Congo, Burundi, and Nigeria. Currently, only 37% of suspected cases in the Democratic Republic of the Congo have been tested.

The Alinity m MPXV assay detects monkeypox virus DNA from skin lesion swabs, allowing trained lab personnel to confirm cases efficiently. The EUL process expedites essential medical product availability during a Public Health Emergency of International Concern (PHEIC) and will remain valid as long as the emergency is in effect.