In News:

In an important move to improve global access to Mpox testing, the World Health Organization (WHO) has listed the first Mpox in vitro diagnostic under its Emergency Use Listing procedure.

• Context of Mpox Outbreak:

• Since January 2022, mpox has spread to 121 countries.
• By September 2024, there were 103,048 confirmed cases and 229 deaths.

• Diagnostic Test Approval:

• WHO approved Abbott Laboratories’ PCR diagnostic test, Alinity MPXV assay, for emergency use.
• This test detects mpox virus DNA from skin swabs, intended for trained lab personnel.

• Emergency Use Listing (EUL) Procedure:

• Allows WHO to expedite approval of unlicensed vaccines, treatments, and diagnostic tests during public health emergencies.
• In August, WHO called for manufacturers to submit diagnostic tools to aid low-income countries.

• Current Testing Landscape:

• Limited testing capacity has hindered response, especially in Africa, where over 30,000 suspected cases were reported in 2024.
• 35 laboratories in India are now equipped to test suspected mpox cases.

• Importance of Early Diagnosis:

• Early detection facilitates timely treatment and control of the virus, essential in outbreak areas.

• Characteristics of the Alinity MPXV Assay:

• Utilizes real-time PCR to detect mpox virus (clade I/II) DNA from lesion materials.
• Designed for skilled laboratory personnel familiar with PCR techniques.

• Ongoing Efforts:

• WHO is reviewing three additional mpox diagnostic tests and negotiating with more companies to enhance availability.
• Efforts include addressing the spread of a new variant, clade Ib, which is affecting more women and children.

• Public Health Implications:

• Expanding access to diagnostics is vital for managing the mpox outbreak and protecting populations, particularly in underserved regions.
• WHO emphasizes the importance of quality-assured medical products in containing the virus spread.