WHO’s First Emergency Mpox Test Approved, Boosting Global Health Response

The World Health Organization (WHO) has taken a significant step in combatting the mpox outbreak by approving its first emergency use diagnostic test, developed by Abbott Laboratories. This approval aims to enhance testing capabilities in countries grappling with the disease.

Named the Alinity m MPXV assay, the test utilizes real-time polymerase chain reaction (PCR) technology to detect mpox virus DNA from human skin lesion swabs. Designed for use by trained clinical laboratory personnel, the diagnostic tool promises rapid and accurate identification of the virus, a crucial factor in containing outbreaks.

Yukiko Nakatani, WHO's assistant director-general for access to medicines and health products, highlighted the significance of this approval. As the first mpox diagnostic test listed under the Emergency Use Listing (EUL), it represents a key milestone in expanding testing availability in affected regions.

The EUL procedure allows for a risk-based assessment of unlicensed vaccines, tests, and treatments, accelerating their availability during public health crises. Currently, the WHO is evaluating three additional mpox diagnostic tests for potential emergency use authorization and is in discussions with other manufacturers to broaden the availability of diagnostic tools for the virus.

Earlier in August, WHO urged manufacturers to submit their diagnostic products for emergency review, emphasizing the need for effective testing solutions, especially for low-income populations.

Mpox was declared a global public health emergency for the second consecutive year in August, following an outbreak that originated in the Democratic Republic of the Congo and subsequently spread to neighboring countries, including Burundi, Uganda, and Rwanda.

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