The World Health Organization on Thursday authorized emergency use of Abbott Laboratories’ mpox diagnostic test, the first approval of its kind in the agency’s effort to bolster testing capabilities in countries facing outbreaks of the disease. the disease.
The real-time PCR test, “Alinity m MPXV assay”, can detect mpox virus DNA from samples of human skin lesions, according to the WHO, which added that it has been designed for use by laboratory personnel qualified clinician.
The agency said it was evaluating three new mpox diagnostic tests for emergency use and was also in talks with other manufacturers to expand the availability of diagnostic tools. “This first Emergency Use Listing (EUL) mpox diagnostic test represents an important milestone in expanding testing availability in affected countries,” said Yukiko Nakatani, deputy director general of WHO for Access to Medicines and Health Products.
In August, the WHO asked manufacturers to subject their products to an emergency review and has held discussions with them about the need for effective diagnostics, especially in low-income groups.
The EUL procedure is a risk-based assessment of unauthorized vaccines, tests and treatments to expedite their availability during public health emergencies. In August, the WHO declared mpox a global public health emergency for the second time in two years, following an outbreak of the viral infection in the Democratic Republic of the Congo, which has spread to neighboring countries Burundi, Uganda and Rwanda. Two strains of mpox are spreading: the clade I variant, endemic in parts of West and Central Africa, and a new, more transmissible clade Ib strain, which has sparked global concern. Sweden, Thailand and India have confirmed cases of the clade Ib type of the virus, outside the Democratic Republic of the Congo and neighboring countries.
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