The World Health Organization (WHO) has granted Emergency Use Listing (EUL) status to the first mpox in vitro diagnostic (IVD), marking a critical step toward improving global access to mpox testing.
The Alinity m MPXV assay, developed by Abbott Molecular Inc., is now approved for emergency use and is expected to significantly enhance diagnostic capacity in countries grappling with mpox outbreaks, where the demand for rapid and accurate testing has soared. Early diagnosis is crucial for timely treatment, care, and containment of the virus.
Africa, in particular, faces challenges due to limited testing capacity and delays in confirming mpox cases, contributing to the virus’s continued spread. In 2024 alone, over 30,000 suspected cases have been reported across the continent, with the Democratic Republic of the Congo (DRC), Burundi, and Nigeria reporting the highest numbers. In the DRC, only 37% of suspected cases have been tested this year.
The WHO’s Interim Guidance on Diagnostic Testing for the Monkeypox Virus (MPXV) recommends nucleic acid amplification testing (NAAT), such as real-time or conventional polymerase chain reaction (PCR), for confirming mpox infections. The preferred sample for diagnostic confirmation is material from lesions.
The Alinity m MPXV assay, a real-time PCR test, detects mpox virus DNA (clade I/II) from human skin lesion swabs. It is designed for use by trained laboratory personnel skilled in PCR techniques and IVD procedures.
This test enables efficient and accurate confirmation of mpox cases by detecting DNA from pustular or vesicular rash samples.
“This first mpox diagnostic test under the Emergency Use Listing procedure is a significant milestone in expanding testing availability in affected regions,” said Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products.
“Increasing access to quality-assured medical products is crucial to helping countries contain the virus and protect their populations, especially in underserved areas.”
The EUL process accelerates the availability of essential medical products—such as vaccines, tests, and treatments—during Public Health Emergencies of International Concern (PHEIC).
On August 28, 2024, WHO called on mpox IVD manufacturers to submit expressions of interest for EUL, in response to the urgent need to boost global testing capacities as the virus continued to spread.
The EUL process evaluates the quality, safety, and performance of diagnostic tests to assist procurement agencies and WHO Member States in making informed decisions for emergency procurement.
Currently, WHO has received three additional submissions for EUL evaluation and is in discussions with other manufacturers to expand the range of quality-assured diagnostic options, this will help countries lacking domestic approval processes procure much-needed tests through UN agencies and other partners.
The EUL for the Alinity m MPXV assay will remain valid as long as the PHEIC justifying its emergency use is in effect. Information on active EUL applications for mpox IVDs is available on the WHO website.
