The World Health Organization (WHO) has approved Abbott Laboratories’ Alinity m MPXV assay as the first emergency use diagnostic test for mpox. This test uses real-time PCR technology to detect the mpox virus from skin lesion swabs, allowing for early and accurate diagnosis, which is crucial in regions facing current outbreaks.
WHO’s Assistant Director-General, Yukiko Nakatani, emphasized that this approval under the Emergency Use Listing (EUL) procedure is a significant step in addressing the mpox outbreak, particularly in lower-income countries. The EUL enables faster access to vaccines, treatments, and tests during public health crises, like the ongoing mpox emergency.
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The approval comes as the virus, with two circulating strains—Clade I and the more transmissible Clade Ib—continues to spread globally. Countries like the Democratic Republic of Congo (DRC), Uganda, and Rwanda are dealing with significant outbreaks, while cases have also emerged in regions like Sweden, Thailand, and India.
In India, the detection of the Clade Ib strain in a 38-year-old man in Kerala has raised alarms, prompting health officials to ramp up testing and vaccination. Globally, efforts are also intensifying, with the European Union expanding the use of the IMVANEX® vaccine, initially for adults, to adolescents aged 12 to 17 after positive safety trials.
The WHO is reviewing additional mpox diagnostic tests, aiming to broaden detection capabilities and curb the virus’s spread. With the approval of Abbott’s test and the continued focus on vaccination, the global response to the mpox outbreak is strengthening, particularly in vulnerable and high-risk populations.
