WHO Approves First Mpox Diagnostic Test for Emergency Use: Expanding Global Access to Mpox Testing

WHO Approval:
The World Health Organization (WHO) has approved the Alinity m MPXV assay, manufactured by Abbott Molecular Inc., as the first mpox in vitro diagnostic test for emergency use.

Emergency Use Listing:
The approval was made through the WHO's Emergency Use Listing (EUL) procedure, which accelerates the availability of critical medical products during public health emergencies.

Global Impact:
This approval marks a significant milestone in expanding testing availability in affected countries, particularly in underserved regions, to contain the spread of the virus and protect populations.

Test Details:
The Alinity m MPXV assay is a real-time polymerase chain reaction (PCR) test that detects mpox virus (clade I/II) DNA from human skin lesion swabs, intended for use by trained clinical laboratory personnel.

Public Health Context:
The approval comes as mpox cases continue to spread, with over 30,000 suspected cases reported in 2024, primarily in Africa, emphasizing the need for rapid diagnostic tools to facilitate early diagnosis and timely treatment.

WHO's Efforts:
The WHO is reviewing additional submissions for EUL assessment and is in discussions with other mpox IVD manufacturers to ensure a broader range of quality-assured diagnostic options.