New Test Added to Recommended List of Molecular Diagnostic Tests for Mpox
April 7, 2025
Africa CDC has added the RADIONE Mpox Detection Kit to its list of recommended molecular diagnostic tests, marking a key advancement in expanding point-of-care (POC) diagnostics across the continent. Manufactured in South Korea by KH Medical, the test detects mpox DNA from clades I and II using automated PCR technology. It previously received WHO Emergency Use Listing in 2024 and passed independent evaluation in the DRC. With limited lab capacity still hindering timely diagnosis, this new addition supports the continent's six-month response plan focused on decentralizing testing and improving outbreak control amid ongoing mpox transmission in 22 African countries.
In a significant move to bolster Africa’s diagnostic capacity amid a sustained mpox outbreak, the Africa Centres for Disease Control and Prevention (Africa CDC) has added a new molecular point-of-care test to its recommended list of mpox diagnostics. The RADIONE Mpox Detection Kit, developed by South Korea’s KH Medical Co. Ltd, becomes the tenth test endorsed by the Africa CDC Diagnostic Advisory Committee (DAC). It uses automated PCR technology to detect mpox DNA, including both clades I and II, from skin lesion samples.
The RADIONE test had already been approved under the WHO Emergency Use Listing in March 2024 and passed independent clinical evaluation by the National Institute of Biomedical Research in the Democratic Republic of the Congo (DRC). Its inclusion supports Africa CDC’s strategy to decentralize laboratory services in alignment with the continental six-month mpox response plan that prioritizes intensified, integrated, and sustainable testing efforts.
This addition comes at a crucial moment. WHO and Africa CDC extended their respective mpox emergency declarations in February 2025 due to rising cases and continued geographic spread. However, testing capacity remains a critical gap, especially in the most affected countries. Poor access to quality-assured diagnostics and a lack of multiplex tools to distinguish mpox from similar diseases continue to complicate containment efforts.
The DAC’s guidance is particularly valuable for policymakers and health ministries navigating procurement amid resource constraints. Its criteria emphasize clade identification, regulatory status, detection limits, and compatibility with WHO-endorsed sample types.
As mpox continues to evolve, accurate and scalable diagnostic tools are essential to identify cases quickly and contain outbreaks. This latest inclusion underscores Africa CDC’s commitment to strengthening local diagnostic capabilities and ensuring equitable access to high-quality testing resources. Regular updates to the list will help maintain clinical relevance as new evidence and technologies emerge.