The World Health Organization (WHO) has officially listed the Alinity m MPXV real-time PCR assay under its Emergency Use Listing (EUL) procedure, marking the first diagnostic test authorized for emergency response against ongoing mpox outbreaks. Manufactured by Abbott Molecular, the test provides public health authorities and reference laboratories with an internationally validated molecular tool to confirm infections rapidly.
The milestone authorization comes as health ministries across central Africa, particularly in the Democratic Republic of the Congo and neighbouring nations, struggle with constrained testing capacity. Limited access to molecular diagnostic supplies has historically delayed case detection, hampering epidemiological tracing and enabling the virus to spread undetected through vulnerable communities.
Accelerating Molecular Diagnostics Across African Laboratory Networks
The Alinity m MPXV assay is an automated real-time polymerase chain reaction test designed to detect viral DNA from skin lesion swabs collected from individuals suspected of contracting mpox. By utilizing automated sample extraction and amplification on Abbott's high-throughput molecular platforms, the system delivers high analytical sensitivity and specificity, distinguishing mpox clades with reliable precision.
Under the WHO Emergency Use Listing framework, the assay becomes immediately eligible for procurement by United Nations agencies, global health partners, and national health authorities without requiring separate, prolonged national regulatory reviews. International financing mechanisms and procurement coalitions can now fast-track bulk shipments directly to epidemic epicenters.
“This first mpox diagnostic test listed under the Emergency Use Listing procedure represents a significant milestone in expanding testing availability in affected countries to halt transmission.” — Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines
Strengthening Outbreak Containment and Surveillance Infrastructure
The Africa Centres for Disease Control and Prevention (Africa CDC) welcomed the listing, emphasizing that decentralized testing remains a cornerstone of the continental outbreak response strategy. Equipping regional laboratories with high-throughput diagnostic platforms will dramatically compress sample turnaround times from days to mere hours, allowing timely patient triage and clinical management.
Global health leaders noted that reliable diagnostics are equally vital for guiding targeted vaccination and therapeutic interventions. As procurement agencies begin deploying the Abbott assay, the WHO is reviewing additional diagnostic submissions, including point-of-care rapid antigen tests, to further broaden community-level testing in remote and conflict-affected regions.
Frequently Asked Questions
What is the Alinity m MPXV assay approved by the WHO?
It is an automated real-time PCR test by Abbott Molecular that detects mpox viral DNA from skin lesion swabs.
Why is the WHO Emergency Use Listing significant for mpox response?
It enables UN agencies and governments to procure and distribute standardized diagnostic tests rapidly without local regulatory delays.
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