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WHO approves first mpox diagnostic test for emergency use
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WHO approves first mpox diagnostic test for emergency use
Oct 4, 2024 6:56 AM

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.

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