The World Health Organization (WHO) formally approved the first in vitro diagnostic test for mpox under its Emergency Use Listing (EUL) procedure. The clearance of the Abbott RealTime m2000 Mpox assay represents a pivotal turning point in global surveillance, establishing a verified benchmark for national regulatory authorities and procurement bodies responding to surging clade Ib viral transmissions.
Under the emergency protocol, the molecular test is authorized to detect mpox viral DNA from lesion swabs collected from symptomatic patients. Prior to this decision, healthcare facilities in the hardest-hit regions of the Democratic Republic of the Congo and neighboring states relied heavily on centralized reference laboratories, causing severe reporting delays.
Emergency Use Listing Unlocks Fast-Track Testing
The Abbott diagnostic operates on automated m2000 systems that are already widely installed across African medical facilities for HIV and viral hepatitis monitoring. Leveraging this existing instrumentation enables rapid clinical rollout without requiring multi-million-dollar capital investments in specialized hardware.
Public health epidemiologists emphasize that timely confirmation is essential to break community transmission chains, initiate contact tracing, and direct scarce therapeutic antivirals to confirmed cases.
“Access to quality-assured diagnostics is the cornerstone of outbreak control. This first EUL test will significantly expand testing capacity in affected countries.” — Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products
Strengthening African Laboratory Networks and Containment
International procurement organizations, including UNICEF, the Global Fund, and Gavi, can now finance and distribute the test kits directly to affected nations without waiting for individual domestic regulatory approvals. The streamlined supply mechanism is projected to reduce diagnostic turnaround times from several weeks to less than 48 hours.
The WHO confirmed that technical evaluations of several other molecular assays, including rapid point-of-care cartridges, remain underway to further diversify supply lines and ensure testing reaches rural primary healthcare clinics.
Frequently Asked Questions
Which diagnostic test received the WHO Emergency Use Listing approval?
The WHO approved the Abbott RealTime m2000 Mpox PCR test, a real-time polymerase chain reaction assay detecting viral DNA.
How will the EUL clearance affect mpox response efforts in Africa?
It allows international agencies to procure and distribute standardized tests rapidly to hospitals using existing m2000 laboratory platforms.
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