The World Health Organization (WHO) authorized Abbott Laboratories' mpox diagnostic test under its emergency use listing (EUL) procedure on October 3, the first such IVD approval by the agency in its effort to expand the diagnostic capacity of countries facing mpox outbreaks.
The Abbott Alinity m MPXV test is a real-time polymerase chain reaction (PCR) assay that enables the detection of mpox virus (clades I and II) DNA from human skin lesion swabs, according to a statement from the WHO. It is designed for use by clinical laboratory personnel who are trained in PCR and IVD procedures.
The EUL process is intended to expedite the availability of medical products such as vaccines, tests, and treatments in the context of a public health emergency of international concern (PHEIC), the WHO explained.
The EUL for the Alinity m MPXV assay will remain valid as long as the PHEIC is in effect.
In late August, the WHO requested that mpox IVD manufacturers submit an expression of interest for an EUL in light of the urgent need to increase global testing capacities as the virus spread.
The WHO said that it has received three additional submissions for EUL evaluation; furthermore, discussions are ongoing with other manufacturers of mpox IVDs. Information on the active candidates for EUL may be found on the WHO website.
The goal is to expedite access to effective tests for countries experiencing or at risk of mpox outbreaks, with procurement through United Nations agencies and other partners.
Outside of the Democratic Republic of Congo and neighboring countries, cases of mpox clade Ib infection have been confirmed in India, Sweden, and Thailand.