The World Health Organization (WHO) announced on Friday that it had approved the first diagnostic test for mpox, marking a critical development for countries grappling with ongoing outbreaks. More than 800 deaths have been reported across Africa, where the disease has been detected in 16 countries, according to the African Union’s disease control center.
The newly approved test, called the Alinity m MPXV assay and manufactured by Abbott Molecular Inc., will be vital in increasing diagnostic capacity in nations facing severe mpox outbreaks. “The approval for emergency use of the test will be pivotal in expanding diagnostic capacity in countries where the need for quick and accurate testing has risen sharply,” the WHO said in a statement.
The test detects mpox virus DNA from swabs taken from human skin lesions, enabling efficient diagnosis of suspected cases. The WHO emphasized that limited testing capacity and delays in confirming mpox cases continue to fuel the virus’s spread across Africa.
Yukiko Nakatani, WHO’s assistant director-general, stated, “The approval of this test is a significant milestone in expanding testing availability in affected countries.” Nakatani further highlighted the importance of increasing access to quality-assured medical products in controlling the spread of the virus and safeguarding public health in underserved regions.
Mpox, formerly known as monkeypox, is transmitted to humans by infected animals but can also spread through close physical contact between humans. The virus causes fever, muscle aches, and large, painful skin lesions, and it can be fatal in some cases.