Health
WHO approves first mpox diagnostic test for emergency use
The World Health Organization (WHO) on Thursday (October 3) authorized Abbott Laboratories' mpox diagnostic test for emergency use. This is the first authorization in the agency's efforts to strengthen testing capacity in countries facing disease outbreaks.
The Alinity m MPXV assay, a real-time PCR test, can detect mpox viral DNA in human skin lesion swabs, WHO said, adding that it is designed to be used by trained clinical laboratory personnel.
The agency said it is evaluating three new mpox diagnostic tests for emergency use and is also in discussions with other manufacturers to expand the availability of mpox diagnostic tools.
“This first mpox diagnostic test listed under the Emergency Use Listing (EUL) procedure marks an important milestone in expanding test availability in affected countries,” the agency said in a statement. said Yukiko Nakatani, deputy director of access to health products.
WHO asked manufacturers in August to submit their products for urgent review and has been consulting with manufacturers about the need for effective diagnostics, especially in low-income groups.
The EUL procedure is a risk-based assessment of unlicensed vaccines, tests and treatments to ensure their rapid availability during public health emergencies.
In August, the World Health Organization (WHO) announced that mpox would become the second global public health concern in the last two years, following an outbreak of the virus in the Democratic Republic of the Congo that spread to neighboring Burundi, Uganda, and Rwanda. It was declared a state of emergency.
Two strains of mpox are prevalent. Clade I variants are endemic in parts of West and Central Africa, and clade Ib is a new, more transmissible strain that is causing global concern.
In addition to the Democratic Republic of the Congo and neighboring countries, cases of clade Ib viruses have also been confirmed in Sweden, Thailand, and India. Reuters
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