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WHO has approved the use of the first diagnostic test for mpox in emergencies
The World Health Organization (WHO) on Thursday authorized the use of Abbott Laboratories’ diagnostic test for mpox virus in emergency situations, the first such approval in a campaign to increase testing capacity in countries facing outbreaks of the disease.
The real-time PCR test, the Alinity m MPXV assay, detects mpox virus DNA in swabs from affected human skin, WHO said, adding that it is intended for use by trained clinical laboratory personnel.
The agency announced that it is evaluating three new tests to diagnose monkeypox for emergency use, and is also in talks with other manufacturers to expand the availability of mpox diagnostic tools.
“This first diagnostic test for mpox on the Emergency Use Listing (EUL) is an important milestone in expanding the availability of testing in affected countries,” said Yukiko Nakatani, the agency’s assistant director general for access to medicines and medical devices.
In August, WHO asked manufacturers to submit their products for emergency review and negotiated with them on the need for effective diagnostics, especially in low-income populations.
The EUL listing procedure is a risk-based evaluation of unlicensed vaccines, tests and treatments to expedite their availability during public health emergencies.
In August, WHO declared monkeypox a global public health emergency for the second time in two years, following an outbreak of the viral infection in the Democratic Republic of Congo that spread to neighboring countries Burundi, Uganda and Rwanda.
Two strains of mpox have spread, clade I, which is endemic in parts of West and Central Africa, and a new, more infectious strain, clade Ib, which has raised global concern.
Cases of clade Ib have been confirmed outside the Democratic Republic of the Congo and neighboring countries, namely in Sweden, Thailand and India.
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