WHO Approves First Mpox Diagnostic Test for Emergency Use, Expanding Global Reach
The World Health Organization (WHO) has listed the first mpox in vitro diagnostic (IVD) under its Emergency Use Listing (EUL) procedure, an important step in improving global access to mpox testing. The approval for emergency use of the Alinity m MPXV assay, manufactured by Abbott Molecular Inc., will be pivotal in expanding diagnostic capacity in countries facing mpox outbreaks, where the need for quick and accurate testing has risen sharply. Early diagnosis of mpox enables timely treatment and care, and control of the virus.
The presence of the monkeypox virus is confirmed by nucleic acid amplification testing (NAAT), such as real-time or conventional polymerase chain reaction (PCR), as stated in the WHO Interim Guidance on Diagnostic testing for the monkeypox virus (MPXV). And the recommended specimen type for diagnostic confirmation of monkeypox virus (MPXV) infection in suspected cases is lesion material.
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 in vitro diagnostic procedures. By detecting DNA from pustular or vesicular rash samples, laboratory and health workers can confirm suspected mpox cases efficiently and effectively.
"This first mpox diagnostic test listed under the Emergency Use Listing procedure represents a significant milestone in expanding 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 in assisting countries to contain the spread of the virus and protect their people, especially in underserved regions."
The Emergency Use Listing for Alinity m MPXV assay, allowing for its use, will remain valid as long as the Public Health Emergency of International Concern, justifying the emergency use of mpox in vitro diagnostics, is in effect.
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