WHO gives green light to first mpox test

In a crucial move to fight the growing mpox crisis, the World Health Organisation (WHO) has approved Abbott Laboratories’ mpox diagnostic test for emergency use. This marks the first approval of its kind as the global health body ramps up efforts to tackle outbreaks across affected regions.

The real-time PCR test, known as the Alinity m MPXV assay, can detect mpox virus DNA from human skin lesion swabs. According to the WHO, the test is specifically designed for use by trained clinical laboratory personnel, ensuring accurate results and safe handling.

Yukiko Nakatani, WHO’s assistant director-general for access to medicines and health products, hailed the move as “a significant milestone in expanding testing availability in affected countries.” With this approval, countries grappling with the virus, particularly those with limited resources, will be better equipped to identify and treat cases promptly.

The WHO is currently evaluating three more mpox diagnostic tests for emergency use and is in talks with other manufacturers to widen access to these critical tools. This expansion is especially urgent as mpox continues to spread, with two distinct strains wreaking havoc. The Clade I variant is endemic to parts of West and Central Africa, while Clade Ib, a more transmissible strain, has alarmed health officials worldwide.

The ongoing outbreaks, particularly in the Democratic Republic of Congo, have crossed borders into Uganda, Burundi, and Rwanda, with countries like Sweden, Thailand, and India also confirming cases of Clade Ib. With the WHO’s emergency use listing procedure, fast-tracking these unlicenced diagnostics could be pivotal in preventing further escalation, reported Bangkok Post.

In related news, the Food and Drug Administration (FDA) has swung into action, kicking off the registration process for mpox diagnostic test kits amid growing fears over the viral infection’s spread. FDA Deputy Secretary-General Lertchai Lertwut revealed the new initiative on August 22.