In News:

• The World Health Organization (WHO) has listed the Alinity m MPXV Assay under its Emergency Use Listing (EUL) procedure.
• The test, developed by Abbott Molecular Inc., will help expand diagnostic capacity in countries experiencing Mpox outbreaks, particularly in Africa.
• Importance of Early Diagnosis:
• Early diagnosis enables timely treatment and virus control.
• It is critical for improving Mpox surveillance, especially in areas with high transmission.

Current Mpox Situation

• Global Context:
  • Over 30,000 suspected cases reported in Africa in 2024.
• India has reported 30 cases since the WHO declared Mpox a global health emergency in August 2024.
• Testing Capacity:
• Limited testing capacity and delays in confirming cases have been a significant barrier to controlling the spread, especially in Africa.
• In India, 35 laboratories are currently equipped to test suspected Mpox cases.

Mpox Diagnostic Test Details

• Alinity m MPXV Assay:
• A real-time PCR test that detects monkeypox virus (MPXV) DNA from skin lesion swabs.
• Used by trained clinical laboratory personnel proficient in PCR techniques.
• Helps confirm suspected Mpox cases from pustular or vesicular rash samples.
• WHO's Role:
• The Emergency Use Listing (EUL) procedure accelerates the availability of life-saving products during public health emergencies.
• WHO aims to increase access to quality-assured diagnostics in regions most affected by Mpox.

About Mpox

• What is Mpox?
• Zoonotic disease caused by the monkeypox virus, part of the Orthopoxvirus genus (family Poxviridae).
• Closely related to smallpox, but generally less severe in humans.
• Transmission:
• Spread via physical contact with infected lesions, body fluids, or contaminated materials.
• Can also spread through animal bites, or activities like hunting, skinning, or eating infected animals.
• Two Clades:
• Clade I: Predominantly in Central and East Africa.
• Clade II: More common in West Africa; linked to the 2022 outbreak.
• Symptoms:
• Rashes, blisters, fever, sore throat, headache, muscle aches, back pain, swollen lymph nodes.
• Lesions typically scab over as they heal.
• Most people experience mild symptoms, but children, pregnant women, and immunocompromised individuals are at greater risk.

Treatment and Prevention

• No Specific Cure:
• Supportive care (e.g., pain relief, hydration) is recommended.
• In some cases, antivirals like tecovirimat (developed for smallpox) may be used under exceptional circumstances.
• Vaccination:
• Three smallpox vaccines are recommended for at-risk individuals: MVA-BN, LC16, and OrthopoxVac.
• Mass vaccination is not recommended by WHO.

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.