Mpox Diagnostic Test Approved Under Emergency Use Listing to Boost Testing Capacity

Abbott's Alinity m MPXV Assay Aims to Improve Detection in Regions Facing Mpox Outbreaks, Particularly in Africa.

The World Health Organization (WHO) has approved the first mpox in vitro diagnostic (IVD) test under its Emergency Use Listing (EUL) procedure, marking a significant advancement in global efforts to increase access to reliable mpox testing. The test, the Alinity m MPXV assay, developed by Abbott Molecular Inc., is designed to rapidly detect mpox (clade I/II) DNA from human skin lesion samples, enabling quicker diagnosis and response in countries grappling with mpox outbreaks.

This emergency approval comes at a crucial time, as mpox cases have surged in regions like Africa, where 30,000 suspected cases were reported in 2024, particularly in the Democratic Republic of the Congo (DRC), Burundi, and Nigeria. In the DRC alone, only 37% of suspected cases have undergone testing due to limited diagnostic capacity, exacerbating the spread of the virus.

The Alinity m MPXV assay is a real-time PCR test designed to be used by skilled clinical laboratory personnel. It targets mpox DNA in samples collected from pustular or vesicular rashes, allowing health workers to efficiently confirm cases and provide timely treatment. By improving diagnostic accuracy, the test will play a key role in containing outbreaks and preventing further transmission, particularly in underserved regions where testing capacity has been historically limited.

"This first mpox diagnostic test listed under the EUL procedure represents a major step in improving testing availability in affected countries,” said Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. "Increasing access to quality-assured medical products is central to our efforts to assist countries in containing the virus, particularly in regions with constrained healthcare systems."

The EUL process was designed to speed up the availability of critical medical products—such as vaccines, tests, and treatments—during public health emergencies. Following WHO's call in August 2024 for mpox IVD manufacturers to submit their products for EUL evaluation, the organization has already received three additional applications, with discussions ongoing with other manufacturers to further expand testing options.

This WHO listing for the Alinity m MPXV assay will remain valid as long as the Public Health Emergency of International Concern (PHEIC) for mpox is in effect, ensuring the continued use of the test in affected regions.

The approval of this first mpox test highlights WHO's commitment to supporting countries' diagnostic capacities and guiding global efforts to mitigate the spread of mpox, especially in regions that lack robust healthcare infrastructures. More information on active EUL applications for mpox IVDs can be accessed through WHO’s official resources. 4o  You said: