The World Health Organization (WHO) has officially approved the Alinity m MPXV assay under its Emergency Use Listing (EUL) procedure, delivering the first internationally validated diagnostic test to combat the escalating mpox emergency. Manufactured by Abbott Molecular, the real-time PCR test enables rapid and sensitive detection of monkeypox virus DNA from human skin lesion swabs.
The approval comes at a critical juncture as African nations, particularly the Democratic Republic of the Congo and neighbouring states, confront an intense surge of the newly emerged clade Ib variant. Public health officials have repeatedly highlighted that inadequate testing capacity has hindered prompt clinical management, contact tracing, and targeted vaccination initiatives across affected communities.
Emergency Listing to Accelerate Outbreak Diagnostics in Africa
Under the Emergency Use Listing mechanism, the WHO evaluates the quality, safety, and performance of critical health technologies to expedite their availability during public health emergencies of international concern. The Alinity m assay demonstrated high diagnostic sensitivity and specificity in clinical evaluations, enabling centralized laboratories to process high-throughput batch samples with minimal turnaround delay.
According to the Africa Centres for Disease Control and Prevention (Africa CDC), less than forty percent of suspected mpox cases in the region have historically received laboratory confirmation due to severe test kit shortages. The introduction of an internationally vetted commercial assay is expected to substantially diminish this diagnostic gap and strengthen epidemiological surveillance.
“This first Emergency Use Listing for an mpox diagnostic test represents a crucial milestone in expanding testing capacity in affected nations where timely confirmation saves lives.” — Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines
Technical Capabilities and Broader Global Response Efforts
The WHO confirmed that it is actively reviewing additional in vitro diagnostic submissions from several global manufacturers to broaden procurement options and lower testing expenditures for developing nations. Global health partnerships, including Unitaid and the Global Fund, are collaborating with regional authorities to facilitate immediate procurement and distribution of the assay.
Health experts emphasized that pairing expanded laboratory testing with ongoing vaccination campaigns and community engagement will be vital to suppressing virus transmission. The deployment of the Alinity m assay provides healthcare workers on the frontline with the diagnostic certainty required to isolate cases early and mitigate cross-border epidemic propagation.
Frequently Asked Questions
What is the Abbott Alinity m MPXV assay approved by the WHO?
It is a real-time PCR diagnostic test manufactured by Abbott Molecular that detects monkeypox virus DNA from patient lesion swabs.
Why is this Emergency Use Listing approval significant for Africa?
It provides the first internationally validated commercial test to expand limited laboratory capacity and rapidly confirm suspected cases.
Comments (0)
Log in to join the discussion.