The World Health Organization (WHO) has approved Abbott Molecular’s Alinity m MPXV assay as the first mpox in vitro diagnostic (IVD) test.
The approval was granted under WHO’s Emergency Use Listing (EUL) to enhance global access to mpox testing. It will help boost diagnostic capacity in countries experiencing mpox outbreaks.
Alinity m MPXV assay will also allow quick, early, and accurate testing for timely treatment and better control of the virus.
The monkeypox virus is confirmed using nucleic acid amplification testing (NAAT), as outlined in the WHO Interim Guidance on diagnostic testing for the virus.
For suspected cases, lesion material is the recommended specimen type for diagnostic confirmation of monkeypox virus (MPXV) infection.
The Alinity m MPXV assay is a real-time polymerase chain reaction (PCR) test designed to detect monkeypox virus (clade I/II) DNA from human skin lesion swabs.
This assay is intended for use by trained clinical laboratory personnel skilled in PCR techniques and IVD procedures.
The test identifies DNA from pustular or vesicular rash samples to confirm suspected mpox cases.
WHO Assistant access to medicines and health products director-general Yukiko Nakatani said: “This first mpox diagnostic test listed under the Emergency Use Listing procedure represents a significant milestone in expanding testing availability in affected countries.
“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.”
EUL process speeds up the availability of essential medical products, including vaccines, tests, and treatments.
WHO declared mpox a global public health emergency for the second time in two years in August.
In August this year, the United Nations agency urged mpox IVD manufacturers to submit expressions of interest for EUL. It highlighted the need to enhance global testing capacities amid the virus’s spread.
As of now, the health agency has received three additional submissions for EUL evaluation. Discussions are ongoing with other mpox IVD manufacturers to expand the range of diagnostic options.
WHO said the effort will help countries that have not approved these medical products through their processes to obtain the necessary tests.
The EUL for the Alinity m MPXV assay will remain valid as long as the Public Health Emergency of International Concern (PHEIC) is in effect.
