A network of laboratories across 10 Sub-Saharan African countries[1], the International Centre for Genetic Engineering and Biotechnology (ICGEB) in Italy, India and South Africa, and the University of Ljubljana (Slovenia) – collectively the EXPANDIA Working Group – has reached an important milestone in diagnosing diseases across the African Continent.
On 25 June 2025, the Group published scientific results in The Lancet Global Health that confirm the reliability of the method they have been testing to detect SARS-CoV-2. They confirm that a Colorimetric RT-LAMP (Reverse Transcription Loop-Mediated Isothermal Amplification) – a one-step nucleic acid amplification method that multiplies specific sequences of RNA to diagnose infectious diseases caused by RNA viruses – is reliable in both extracted RNA and crude saliva samples (without RNA extraction).
The value of this outcome is twofold: it confirms the method as accurate, robust, and cost-effective, and available for efficient scale-up, improving the rapid diagnosis of outbreaks in areas where access to essential resources is significantly restricted.
“The key strength of the study lies in its comprehensive, multi-country clinical evaluation of an innovative molecular diagnostic tool, specifically in – and for – Africa,” comments Dr. Alessandro Marcello, Chief Scientist of EXPANDIA. “This work is a milestone in the process of building sustainable diagnostic capacity for infectious disease on the African Continent”.
The clinical trials undertaken reflect the real-world challenges faced by different laboratories, particularly community laboratories in low-income and middle-income countries, and provide an alternative to the gold-standard quantitative Real Time-PCR method of disease detection. “This technique is straightforward, particularly in the interpretation of results, as infected samples can be simply detected by observing a colour change in the reaction” – confirms Dr. Molalegne Bitew from the Bio and Emerging Technology Institute (Ethiopia) – “this means there is no need for specific training and sophisticated equipment to run the test”. Well suited for point-of-care use in low-resource settings, the tool is being developed for the detection of other RNA viral diseases of critical importance, including Dengue, Zika, and Chikungunya.
The EXPANDIA Working Group also collaborates with government regulatory bodies to provide evidence for the recognition of the technique as a valid diagnostic test in partner countries. “Three countries have already approved the technique for clinical diagnosis, while this study will contribute to a further validation of RT-LAMP in other partner countries in Africa”, comments Dr. Wendy Craig, Head of Regulatory Science at the ICGEB.
The project, supported by the Gates Foundation, builds on earlier work undertaken by the reference laboratories in Africa to increase their diagnostic and surveillance capacity. This has been through the transfer of scientific knowledge and expertise and testing of innovative technologies suitable for low-resource settings and remote areas.
Given the scarcity of facilities and infrastructures in the interested areas, EXPANDIA has set its sights on increasing access to, and knowledge of, high-quality and cost-effective diagnostic tools relevant to local needs across the African Continent, engaging companies interested in scaling-up local production, and working closely with the Africa Centres for Disease Control and Prevention.
Link to Article:
Colorimetric RT-LAMP for SARS-CoV-2 detection from nasopharyngeal swabs or crude saliva: a multicountry diagnostic accuracy study in Africa
Post-publication link: https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(25)00150-0/fulltext
[1] Angola; Burkina Faso; Cameroon; Ethiopia; Ivory Coast; Kenya; Nigeria; Senegal; Sudan; Zimbabwe
This material is based on research funded by the Gates Foundation. The findings and conclusions contained within are those of the authors and do not necessarily reflect positions or policies of the Gates Foundation.
