The WHO has listed the Alinity m MPXV assay for mpox testing under its Emergency Use Listing, enhancing global diagnostic capacity amid rising outbreaks. This real-time PCR test allows for quick detection of the monkeypox virus from skin lesion swabs, aiming to improve timely treatment and control.
The World Health Organization (WHO) has listed the first mpox in vitro diagnostic (IVD) under its Emergency Use Listing (EUL) procedure, marking a significant advancement in enhancing global access to mpox testing.
In an official statement, WHO said that the emergency use approval for the Alinity m MPXV assay, produced by Abbott Molecular Inc., pivotal in expanding diagnostic capacity in countries facing mpox outbreaks, where the need for quick and accurate testing has risen sharply.
What is Emergency Use Listing (EUL) procedure?
The Alinity m MPXV assay is a real-time PCR test that enables detection of monkeypox virus (clade I/II) DNA from human skin lesion swabs. It is specifically designed for use by trained clinical laboratory personnel who are proficient in PCR techniques and IVD procedures.
“By detecting DNA from pustular or vesicular rash samples, laboratory and health workers can confirm suspected mpox cases efficiently and effectively,” said WHO.
The EUL process accelerates the availability of life-saving medical products, such as vaccines, tests and treatments, in the context of a Public Health Emergency of International Concern (PHEIC).
Earlier on 28 August 2024, WHO called on mpox IVDs manufacturers to submit an expression of interest for EUL, recognizing the urgent need to bolster global testing capacities as the virus continued to spread.
Moreover, the EUL process assesses the quality, safety, and performance of essential health products, such as diagnostic tests, to guide procurement agencies and WHO Member States in making informed decisions for time-limited emergency procurement.