Oct 3 (Reuters) - The World Health Organization
authorized Abbott Laboratories' ( ABT ) mpox diagnostic test for
emergency use on Thursday, the first such approval in the
agency's effort to bolster testing capabilities in countries
facing outbreaks of the disease.
The real-time PCR test, Alinity m MPXV assay, enables
detection of mpox virus DNA from human skin lesion swabs, the
WHO said, adding that it was designed for use by trained
clinical laboratory personnel.
"This first mpox diagnostic test listed under the Emergency
Use Listing (EUL) procedure represents a significant milestone
in expanding testing availability in affected countries," said
Yukiko Nakatani, the agency's assistant director-general for
access to medicines and health products.
An Abbott spokesperson said that the company "currently
has the Alinity m mpox test in inventory and will work with
customers on their testing needs".
The agency said it was evaluating three new mpox diagnostic
tests for emergency use and was also in discussions with other
manufacturers to expand the availability of mpox diagnostic
tools.
In August, WHO asked manufacturers to submit their products
for an emergency review. The EUL procedure is a risk-based
assessment of unlicensed vaccines, tests and treatments to
expedite their availability during public health emergencies.
The WHO declared mpox a global public health emergency for
the second time in two years in August, following an outbreak of
the viral infection in the Democratic Republic of Congo, which
has spread to neighbouring Burundi, Uganda and Rwanda.
Two strains of mpox are spreading - the clade I variant,
which is endemic in parts of West and Central Africa and a new,
more transmissible strain clade Ib, which has triggered global
concern.
Sweden, Thailand, and India have confirmed cases of the
clade Ib type of the virus, outside of the Democratic Republic
of Congo and neighboring countries.