WHO approves Abbott's Mpox test for emergency use in outbreak zones

Cases of the clade Ib strain of the virus have been confirmed in Sweden, Thailand, and India, outside of Democratic Republic of Congo and neighbouring nations

The World Health Organisation (WHO) has granted emergency use authorisation for Abbott Laboratories’ Mpox diagnostic test, marking the first approval under the agency’s initiative to strengthen testing capabilities in regions experiencing Mpox outbreaks.

The test, called the Alinity m MPXV assay, is a real-time PCR test that detects Mpox virus DNA from human skin lesion swabs. The WHO noted that this test is intended for use by trained personnel in clinical laboratories.

In addition to this approval, the WHO announced that it is currently evaluating three more Mpox diagnostic tests for emergency use and is in talks with other manufacturers to further expand the availability of diagnostic tools for Mpox.

Yukiko Nakatani, WHO assistant director-general for access to medicines and health products, described the listing of this first Mpox diagnostic test under the Emergency Use Listing (EUL) procedure as a major step in increasing testing availability in affected regions.

Earlier in August, the WHO had called on manufacturers to submit their diagnostic products for emergency evaluation, emphasising the importance of accessible and effective diagnostics, especially for low-income populations.

The EUL procedure allows for a risk-based evaluation of unlicensed vaccines, treatments, and tests aimed at speeding up their availability during public health crises.

Mpox: A public health emergency

Mpox was declared a global public health emergency by the WHO for the second time in two years in August, following an outbreak in the Democratic Republic of Congo, which has since spread to Burundi, Uganda, and Rwanda.

Two strains of the Mpox virus are currently circulating: Clade I, which is endemic to parts of West and Central Africa, and Clade Ib, a more transmissible variant that has raised global concerns.

Cases of Clade Ib have been confirmed in Sweden, Thailand, and India, as well as in the Democratic Republic of Congo and neighbouring countries.

Mpox cases in India

Last month, India reported its first case of the more dangerous strain of Mpox, causing concern among global health authorities due to its fast transmission. Health officials in Kerala confirmed the presence of the clade Ib strain in a 38-year-old man who had recently returned from Dubai.

(With agency inputs)