The World Health Organization has cleared the first mpox diagnostic test under its Emergency Use Listing procedure, a move designed to speed up testing in countries where the virus has spread fastest. The approved test — the Alinity m MPXV assay, made by Abbott Molecular Inc. — uses real-time PCR technology to detect monkeypox virus DNA from skin lesion swabs, and is now available for procurement through United Nations agencies and other partners.
At a glance
- Mpox diagnostic test: The Alinity m MPXV assay detects both clade I and clade II monkeypox virus DNA from pustular or vesicular rash samples, giving trained laboratory personnel a fast and reliable confirmation method.
- Emergency Use Listing: WHO’s EUL process evaluates the quality, safety, and performance of health products during a Public Health Emergency of International Concern, allowing countries without their own approval pathways to procure tested products through UN agencies.
- Mpox outbreak in Africa: More than 30,000 suspected mpox cases were reported across Africa in 2024 C.E., with the Democratic Republic of the Congo, Burundi, and Nigeria recording the highest numbers — and only 37% of suspected DRC cases confirmed by testing.
Why testing gaps matter
When cases go unconfirmed, outbreaks are harder to track and contain. In the DRC, where mpox has hit hardest, limited lab infrastructure means most suspected cases never receive a definitive diagnosis. That gap slows the public health response at every level — from contact tracing to treatment decisions to resource allocation.
Early diagnosis changes that equation. It allows health workers to isolate confirmed cases faster, begin appropriate care sooner, and give surveillance teams the data they need to map transmission in real time. The Alinity m MPXV assay is designed specifically for trained clinical laboratory staff already familiar with PCR and in vitro diagnostic procedures, which means it can slot into existing lab workflows in countries with some diagnostic infrastructure already in place.
A faster path from submission to approval
WHO declared mpox a Public Health Emergency of International Concern in August 2024 C.E. Within weeks, it called on mpox diagnostic manufacturers to submit expressions of interest for emergency listing. The Abbott assay is the first to complete that process.
The EUL pathway exists precisely for moments like this. It doesn’t replace a country’s own regulatory approval — it creates a parallel route that lets procurement agencies and governments access quality-assured products quickly, without waiting for full national review processes that can take months or years. The listing stays valid as long as the PHEIC remains in effect.
“This first mpox diagnostic test listed under the Emergency Use Listing procedure represents a significant milestone in expanding testing availability in affected countries,” said Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. “Increasing access to quality-assured medical products is central to our efforts in assisting countries to contain the spread of the virus and protect their people, especially in underserved regions.”
More tests are coming
Abbott’s approval is the first, but it won’t be the last. WHO has already received three additional submissions for EUL evaluation and is in active talks with other mpox diagnostic manufacturers. A wider menu of approved tests matters — different countries have different supply chains, cold-storage capacity, and lab setups. No single test works everywhere.
This diversification also reduces dependence on any one supplier, a vulnerability that became painfully clear during the COVID-19 pandemic when demand for a narrow range of tests overwhelmed production. Research published in Nature Medicine found that diagnostic bottlenecks during earlier outbreaks directly delayed containment efforts, a pattern WHO is clearly working to avoid repeating.
What remains unresolved
The Alinity m MPXV assay requires trained personnel and PCR-capable lab equipment — conditions that remain scarce in many of the communities most affected by the current outbreak. Approving a test and deploying it at scale in resource-limited settings are two different challenges. Health systems in parts of Central and West Africa will still need investment in infrastructure, trained staff, and supply chains before this approval translates fully into on-the-ground testing capacity.
Still, this listing marks a real step forward. It gives governments, UN procurement agencies, and global health partners like Gavi a quality-assured product to point to — one that has cleared WHO’s bar for safety and performance. Combined with existing CDC treatment guidance and the continued push for vaccine access, expanded diagnostics form a critical piece of the response. Médecins Sans Frontières and other organizations working in affected regions have long called for exactly this kind of quality-assured testing support.
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For more on this story, see: World Health Organization
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