The Africa Centres for Disease Control and Prevention (Africa CDC) Diagnostic Advisory Committee (DAC) on March 12, 2025, added a new point -of -care test for mpox on its recommended list of Molecular Diagnostic Tests. This update captured in thefourth edition review, forms part of ongoing efforts to improve access to mpox diagnostics across the continent.
The molecular test, known as the RADIONE Mpox Detection kit, is manufactured by KH Medical Co. Ltd in South Korea. The automated PCR test is designed to to detect Mpox DNA, including clade I and clade II, in skin lesion samples obtained from patients presenting with mpox symptoms.
The test was previously listed by the World Health Organisation (WHO) on March 6, 2024, under the WHO Emergency Use Listing (EUL) procedure.
“The DAC reviewed the submission and concluded that the test fulfilled all the set criteria, with additional data from independent clinical evaluation conducted at the National Institute of Biomedical Research in the Democratic Republic of Congo,” said Dr Noah Takah Fongwen,Senior Technical Officer for Diagnostic access.
The DAC’s recommendation of the POC molecular tests by will be followed by engagement with the continental regulatory framework, moving toward Emergency Use Listing through the African Medicines Regulatory Harmonisation (AMRH) programme.
The new addition brings the total number of tests on the DAC’s recommended list to ten.
Due to the rising number of cases and the continued reporting of new Mpox infections across multiple countries, WHO and Africa CDC extended their Public Health Emergency of International Concern (PHEIC) and Public Health Emergency of Continental Security (PHECS) on February 24 and 25, 2025, respectively, for an additional three months.
Africa CDC initially declared the Mpox outbreak a PHECS on August 13, 2024. WHO followed suit the next day, elevating the international alert to a PHEIC. Since these declarations, numerous countries have mobilized resources to introduce or scale up laboratory testing, surveillance, and response activities.
One of the most urgent challenges remains the limited availability of testing laboratories, particularly in the hardest hit countries. This has created an urgent need to expand testing capacity through laboratory decentralization, in line with the Mpox continental response plan for the next six months, which prioritizes intensification, integration, and sustainability.
However, access to appropriate, quality-assured diagnostics remains limited. There is insufficient publicly available information on the performance, reliability and mpox clade detection capabilities of many test kits. Additionally, the absence of multiplex diagnostic tools capable of distinguishing Mpox from other pathogens with similar clinical presentations continue to complicate case detection and outbreak response.
The Diagnostic Advisory Committee is continuously reviewing all available evidence on molecular tests for mpox and and shortlisting those deemed useful for country- level testing,”, said Dr Fongwen. “The shortlist aims to guide Africa CDC, Member States, and partners in procuring and deploying high-quality molecular tests for the mpox response.” Africa CDC has published three previous editions of its recommended test list.
To shortlist the appropriate molecular tests for mpox, the DAC review is based on currently available literature, expert feedback in the field and the Target Product Profile published by the WHO as guidance. Shortlisted tests for mpox must meet the following key criteria:
Clade identification: The test should specifically identify mpox clades I and II, even if precise differentiation between the two clades is not possible.
Limit of Detection (LoD): The LoD should not exceed 1,000 copies/ml.
Cross-reactivity: There should be no cross-reactivity with non-Ortho poxviruses with similar signs and symptoms. At least one mpox specific target should not cross-react with known human Orthopox viruses.
Sample type: The test should be compatible with sample types specified in the TPP. The manufacturer should indicate the sample type(s) for which the assay is designed.
Regulatory status: The test should have regulatory approval or emergency use listing (for either in vitro diagnostic or research use) from at least one of the agencies recognized as a stringent regulatory agency, such as United States Food and Drug Authority, European Union CE, Japan Pharmaceutical and Medical Devices Agency or Australian Therapeutic Goods Administration, or others.
Availability of performance evaluation data from an African country is considered a significant advantage. In future reviews, DAC will also consider approvals from national regulatory agencies or the African continental process, supported by quality-assured performance evaluation data. Tests listed as “Research Use Only” but independently evaluated or widely used in African labs and under regulatory review were also considered.
Using these criteria and working with test information available from manufacturers and other sources, the DAC has identified the recommended list of molecular tests for mpox. This list was produced based on available evidence and will be updated regularly as additional information on existing or new or modified tests becomes available. The DAC will review this evidence and update the list with tests that meet the minimum requirements.
