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 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.
So far, WHO has received three additional submissions for EUL evaluation, and discussions are ongoing with other manufacturers of mpox IVDs to ensure a wider range of quality-assured diagnostic options.
The EUL for Alinity m MPXV assay, allowing for its use, will remain valid as long as the PHEIC, justifying the emergency use of mpox in vitro diagnostics, is in effect.
