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WHO Approves First Mpox Diagnostic Test to Enhance Global Testing Access
The World Health Organization (WHO) has officially included the inaugural mpox in vitro diagnostic (IVD) test in its Emergency Use Listing (EUL) procedure. This significant development aims to enhance worldwide access to mpox testing. The emergency authorization of the Alinity m MPXV assay, produced by Abbott Molecular Inc., is crucial for increasing diagnostic capabilities in nations experiencing mpox outbreaks, where the demand for rapid and precise testing has surged dramatically. Early detection of mpox is vital for ensuring prompt treatment and effective virus control.
In Africa, challenges such as limited testing capacity and delays in confirming cases continue to hinder efforts against the virus’s spread. As of 2024, more than 30,000 suspected cases have been reported across the continent, with the highest incidences occurring in countries like the Democratic Republic of the Congo, Burundi, and Nigeria. Alarmingly, only 37% of suspected cases have undergone testing this year in the Democratic Republic of the Congo.
The monkeypox virus can be confirmed through nucleic acid amplification tests (NAAT), including real-time or conventional polymerase chain reaction (PCR), as outlined in the WHO Interim Guidance on Diagnostic Testing for Monkeypox Virus. For accurate diagnosis of monkeypox infection among suspected individuals, lesion material is recommended as a specimen type.
The Alinity m MPXV assay functions as a real-time PCR test that detects DNA from monkeypox virus clades I and II using samples taken from human skin lesions. It is specifically intended for use by trained laboratory personnel skilled in PCR methodologies and IVD protocols. By identifying DNA from pustular or vesicular rash samples efficiently, healthcare professionals can confirm suspected mpox cases effectively.
“The inclusion of this first mpox diagnostic test under our Emergency Use Listing procedure marks a pivotal achievement towards enhancing testing availability within affected regions,” stated Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. “Expanding access to high-quality medical products is essential for supporting countries’ efforts to curb viral transmission and safeguard their populations—particularly those living in underserved areas.”
Accelerating Access Through EUL Process
The EUL process expedites access to life-saving medical products—including vaccines, tests, and treatments—during Public Health Emergencies of International Concern (PHEIC). On August 28th 2024, WHO urged manufacturers of mpox IVDs to express their interest for EUL consideration, acknowledging an urgent need to strengthen global testing capabilities amid ongoing viral spread. The EUL process evaluates essential health products‘ quality, safety standards, and performance metrics so that procurement agencies along with WHO Member States can make informed decisions regarding emergency procurement needs.
To date, WHO has received three additional submissions seeking EUL evaluation while discussions are underway with other manufacturers producing mpox IVDs aimed at broadening available quality-assured diagnostic options. This initiative will assist countries lacking local approval processes by enabling them to acquire necessary tests through UN agencies alongside other procurement partners.
Ongoing Validity & Further Information
The Emergency Use Listing granted for Alinity m MPXV assay will remain valid throughout the duration that PHEIC justifying its emergency use persists.
For updates on active EUL applications related to mpox IVDs visit these WHO webpages.
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