NEW YORK – The World Health Organization on Thursday announced that Abbott's Alinity M MPXV assay has been listed under the agency's Emergency Use Listing (EUL) procedure.
The real-time PCR test detects monkeypox virus DNA from human skin lesion swabs and is designed for use by trained clinical laboratory personnel.
The EUL process accelerates the availability of medical products during a Public Health Emergency of International Concern (PHEIC), the WHO said in a statement. The organization called on mpox IVD manufacturers to submit an expression of interest for EUL on Aug. 28. In the process, medical products are assessed for quality, safety, and performance to guide procurement agencies and WHO member states in making informed decisions for time-limited emergency procurement, the WHO noted.
"This first mpox diagnostic test listed under the Emergency Use Listing procedure represents a significant milestone in expanding testing availability in affected countries," Yukiko Nakatani, WHO assistant director-general for access to medicines and health products, said in a statement. "Increasing access to quality-assured medical products is central to our efforts in assisting countries to contain the spread of the virus and protect their people, especially in underserved regions."
Thus far, the WHO has received three additional submissions for EUL evaluation and said it is in discussions with other mpox test manufacturers. The EUL for Abbott's test will remain valid as long as the PHEIC is in place.
The test received Emergency Use Authorization from the US Food and Drug Administration in 2022 for use in CLIA-certified laboratories.