WHO gives approval to first Mpox diagnostic test

• The World Health Organization (WHO) has listed the first Mpox in vitro diagnostic under its Emergency Use Listing procedure.

Highlights:

• In a critical move to enhance global access to Mpox testing, the World Health Organization (WHO) has approved the first Mpox in vitro diagnostic under its Emergency Use Listing (EUL) procedure.
• The Alinity m MPXV assay, developed by Abbott Molecular Inc, will play a pivotal role in expanding testing capacities, particularly in regions grappling with Mpox outbreaks.

Importance of Early Diagnosis:

• Mpox outbreaks in several regions, especially Africa, have underscored the need for timely testing and diagnosis. WHO emphasized the importance of early detection for:
  • Quick treatment and care of affected individuals.
  • Control of the virus to prevent its spread.
• With accurate and timely tests, health authorities can take prompt action to manage outbreaks more effectively.

Mpox Response and Testing Infrastructure:

• As of now, 35 laboratories across India are equipped to test for Mpox, and since WHO's declaration of a public health emergency in mid-August 2024, 30 cases have been reported in India.
• Globally, especially in Africa, the lack of testing capacity and delayed confirmations have exacerbated the outbreak, leading to over 30,000 suspected cases in 2024.

Role of the Alinity m MPXV Assay:

• The Alinity m MPXV assay is a real-time PCR test designed to detect Mpox (clade I/II) DNA from human skin lesions.
• This test is crucial for trained laboratory personnel and uses nucleic acid amplification techniques to confirm Mpox in suspected cases.
• The assay detects DNA from pustular or vesicular rash samples, allowing quick and accurate confirmation of the virus in patients.

Challenges in Africa: Limited Testing Capacity:

• WHO highlighted that testing capacity remains limited in Africa, leading to delays in identifying and controlling the virus.
• This has contributed to the continued spread of Mpox, despite efforts to contain it. Addressing these challenges by improving testing infrastructure is essential to curbing the virus's reach.

Emergency Use Listing (EUL) Process:

• The EUL process allows for the accelerated availability of life-saving medical products, such as diagnostics, vaccines, and treatments, during public health emergencies.
• This recent approval of the Alinity m MPXV assay under the EUL is expected to significantly expand testing availability in affected countries, especially those with underdeveloped health infrastructure.

WHO's Commitment to Expanding Access:

• Yukiko Nakatani, WHO’s assistant director-general for access to medicines and health products, stressed the importance of increasing access to quality-assured medical products to help countries contain the spread of Mpox.
• This initiative is especially crucial for underserved regions where testing and healthcare infrastructure is still developing.

Prelims Takeaways:

• monkeypox virus
• Polymerase chain reaction (PCR)