The WHO has approved Abbott Laboratories' mpox diagnostic test for emergency use, marking a key step in boosting testing in outbreak-hit countries. The real-time PCR test detects mpox virus DNA from skin swabs, with more tests under review to increase diagnostic availability worldwide.
The World Health Organization (WHO) has approved Abbott Laboratories' mpox diagnostic test for emergency use, making it the first to receive such authorization in the push to improve testing in outbreak regions.
The Alinity m MPXV assay, a real-time PCR test, identifies mpox virus DNA from skin lesion swabs and is designed for trained laboratory staff.
Abbott currently has the test available and is prepared to address customer requirements. The WHO is also reviewing three more mpox diagnostic tests and working with manufacturers to broaden access. The EUL procedure helps fast-track unlicensed vaccines, tests, and treatments during health emergencies.
"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, WHO's assistant director-general.
WHO declared mpox a global public health emergency following an outbreak in the Democratic Republic of Congo that spread to Burundi, Uganda, and Rwanda. Two strains, clade I and the more transmissible clade Ib, have raised global concern, with confirmed cases of clade Ib in Sweden, Thailand, and India.
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