WHO authorized Abbott Molecular's Alinity m MPXV PCR assay under its Emergency Use Listing
WHO clears Abbott test to break mpox testing bottleneck
Emergency listing opens UN procurement pipeline for African clinics facing 30,000 cases
In a nutshell
The World Health Organization granted its first emergency listing for an mpox diagnostic test, clearing Abbott Molecular's automated PCR kit for bulk purchase by United Nations agencies. The approval addresses an acute diagnostic shortfall in Central Africa, where fewer than four in ten suspected cases received laboratory confirmation amid a 2024 surge topping 30,000 infections.
Highlights
- WHO authorized Abbott Molecular's Alinity m MPXV assay as its first emergency mpox diagnostic.
- The automated test confirms viral DNA from human skin swabs in about two hours.
- More than 30,000 suspected mpox cases emerged across Africa during 2024.
- Only 37% of suspected mpox cases in the Democratic Republic of the Congo had laboratory confirmation.
- WHO officials are reviewing three additional commercial tests for decentralized settings.
From the Editor’s Diary
Emergency regulatory authorization bridges supply gaps only when matched by regional laboratory infrastructure capable of running complex automated hardware.
Who's involved
World Health Organization
United Nations public health agency
goal → Validate emergency diagnostics to widen testing in outbreak zones
Abbott Molecular Inc.
United States diagnostics maker
goal → Deliver automated PCR assays to international supply chains
Democratic Republic of the Congo
Central African nation facing most suspected cases
goal → Expand laboratory confirmation to curb viral transmission
Africa CDC
African Union public health agency
goal → Clear specimen bottlenecks and raise low confirmation rates
In short
The World Health Organization cleared its first emergency mpox diagnostic, opening a direct pipeline for United Nations agencies to buy and ship reliable testing kits across Africa.
Global procurement groups are now positioned to distribute automated laboratory assays straight to front-line outbreak zones without waiting for local drug agencies to approve them.
That rollout remains likely because the emergency mechanism bypasses domestic regulatory voids, though its immediate reach stays tied to laboratories equipped with trained clinical staff.
How it unfolded
WHO triggers global alert over regional case surge
Surging clade I and Ib infections across Central and East Africa forced international health leaders to activate emergency procurement rules.
WHO issues first emergency green light to Abbott
Emergency listing gave global relief agencies clearance to buy Abbott's two-hour test for low-income nations lacking domestic regulators.
Where things stand
Abbott's authorization remains active for the duration of the international mpox emergency.
The agency is reviewing three additional diagnostic applications to bring testing closer to decentralized community clinics.