WHO approves first mpox diagnostic test for emergency use

The World Health Organization (WHO) has made a critical advancement in the fight against Mpox by granting emergency use authorization for Abbott Laboratories’ Alinity m MPXV assay, marking the first diagnostic test to receive approval under WHO’s initiative to enhance testing in regions affected by Mpox outbreaks. This approval represents a significant step forward in increasing global testing capacity, particularly in regions where testing has been limited.

What Is the Alinity m MPXV Assay?

The Alinity m MPXV assay is a real-time PCR test designed to detect Mpox virus DNA from human skin lesion swabs. This tool will play a pivotal role in ensuring faster and more accurate diagnosis of the Mpox virus, allowing for quicker treatment and containment of outbreaks. Importantly, the test is intended for use by trained laboratory personnel to ensure accuracy and efficiency in processing samples.

Expanding Testing Capacity for Mpox

Alongside this approval, WHO is currently evaluating three additional Mpox diagnostic tests and is in discussions with various manufacturers to expand the availability of diagnostic tools worldwide. As Mpox continues to spread, particularly in regions like the Democratic Republic of Congo, Burundi, Uganda, and Rwanda, this expansion of testing capacity is essential for global health security.

The WHO’s Emergency Use Listing (EUL) Procedure

The WHO’s Emergency Use Listing (EUL) procedure, under which this test was approved, is designed to fast-track the availability of unlicensed vaccines, treatments, and diagnostic tools during public health crises. This procedure allows for a risk-based evaluation to quickly deliver critical medical tools to regions in need, especially low-income populations facing health emergencies.

Mpox: A Continuing Global Public Health Emergency

Mpox was first declared a global public health emergency by WHO in August 2024, following outbreaks in Central and West Africa. Two primary strains of the virus are currently circulating: Clade I, endemic to parts of West and Central Africa, and the more transmissible Clade Ib, which has raised global concerns due to its spread in countries like Sweden, Thailand, and India.

Mpox in India

In recent months, India has reported its first case of the Clade Ib strain of Mpox. In August 2024, health officials in Kerala confirmed the infection in a 38-year-old man who had returned from Dubai. The rapid transmission of this strain is a cause for concern among global health authorities, as the virus continues to spread beyond its original regions.

The Importance of Timely Diagnosis

With the Alinity m MPXV assay now available for emergency use, countries like India and other affected regions will have better access to reliable diagnostic tools to control the virus and prevent further spread. Early diagnosis and timely treatment will be critical in minimizing the impact of this global health emergency.

Conclusion: A Major Step in Mpox Control

WHO’s approval of the first Mpox diagnostic test for emergency use represents a major milestone in global health. By improving diagnostic capabilities in regions most affected by Mpox, this test will help healthcare systems respond more effectively to the virus, enhancing containment efforts and reducing the global burden of the disease.

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