The World Health Organization (WHO) has taken a significant step in the fight against mpox by listing the first in vitro diagnostic (IVD) test under its Emergency Use Listing (EUL) procedure. This approval is expected to greatly enhance global access to mpox testing, particularly in regions heavily impacted by the virus.
The approved test, known as the Alinity m MPXV assay, is manufactured by Abbott Molecular Inc. This diagnostic tool will be crucial in expanding testing capacity in countries experiencing mpox outbreaks, where the demand for rapid and accurate testing has surged. Early diagnosis of mpox is essential for timely treatment, care, and control of the virus.
Limited testing capacity and delays in confirming mpox cases have been significant challenges, especially in Africa. In 2024, over 30,000 suspected mpox cases have been reported across the region, with the highest numbers in the Democratic Republic of the Congo, Burundi, and Nigeria. In the Democratic Republic of the Congo, only 37% of suspected cases have been tested this year.
The WHO’s decision to approve the Alinity m MPXV assay for emergency use is a critical development in addressing these challenges and improving the overall response to mpox outbreaks. The global health body emphasized that this step will help in controlling the spread of the virus by enabling quicker and more accurate diagnosis.
