In the ongoing fight against Crimean-Congo Haemorrhagic Fever (CCHF), Global Access Diagnostics (GADx) has joined forces with the Liverpool School of Tropical Medicine and international experts to develop a rapid diagnostic test (RDT) tailored for use in endemic settings. Published in eBioMedicine, this research showcases a critical advancement in tackling one of the world’s most challenging viral threats.
CCHF is a tick-borne disease with a mortality rate as high as 30%, and it disproportionately affects rural communities where access to medical infrastructure may be scarce. Diagnostics for CCHF rely on complex lab-based methods, leaving frontline health workers with limited tools to manage outbreaks effectively. Addressing this, the newly developed RDT provides a faster, simpler solution that could shift the paradigm of CCHF detection.
What the Results Say—and Why They Matter
The prototype RDT’s performance was rigorously evaluated in Türkiye and Iraq, delivering promising results:
- Türkiye: The test demonstrated a remarkable sensitivity of 90.4% and specificity of 96.2% in prospectively collected clinical samples. These figures not only meet but exceed the World Health Organization’s (WHO) benchmark for CCHF diagnostics.
- Iraq: While the sensitivity in retrospective samples was slightly lower at 71.7%, the specificity remained high at 92.5%. Importantly, the test achieved 100% sensitivity in high-viral-load cases (cycle thresholds ≤20), highlighting its effectiveness in the most urgent scenarios.
The takeaway? This RDT could be a game-changer in the early detection of cases, enabling swift action to prevent the disease’s spread and save lives.
GADx’s Role in Driving Innovation
This achievement was due to the collaborative nature of the approach— and GADx’s contributions were instrumental in several key areas:
- Technological Expertise & Collaboration: GADx lent its deep knowledge in monoclonal antibody development and lateral flow test design to ensure the RDT was both reliable and adaptable. LSTM staff and PhD students were able to collaborate and join GADx in our laboratories for development.
- Optimisation and Training: The company worked closely with key opinion leaders and healthcare teams to refine the test, optimise its accuracy, and ensure smooth implementation in real-world conditions.
- Global Perspective: Drawing on its experience in diagnostics for underserved regions, GADx helped shape the RDT into a tool that fits the needs of the most vulnerable communities.What’s Next? Turning Potential into Reality
While these results are exciting, the work is far from over. The team is already looking ahead to the next phases of development:
- Expanding trials to include diverse geographies, ensuring the RDT’s reliability across viral strains and settings.
- Adapting the test for whole blood samples, making it even more practical for point-of-care use.
- Conducting cross-reactivity studies to confirm specificity and rule out interference from other pathogens common in endemic regions.
- Planning for full-scale IVDR-compliant clinical evaluations of the design-locked device in endemic settings.
The goal? A diagnostic tool that is not only effective but also affordable, scalable, and ready to meet the realities of rural healthcare.
A Collective Step Forward in Global Health
This collaboration highlights what’s possible when expertise, resources, and a shared commitment to global health come together. For GADx, being part of this effort is both a privilege and a responsibility—a chance to contribute to a future where diagnostics are no longer a barrier to health equity.
The RDT may not solve every challenge posed by CCHF, but it represents hope: hope for faster diagnoses, better patient outcomes, and a stronger defense against future outbreaks. At GADx, we’re proud to be part of this story, and we remain committed to advancing diagnostics that make a difference where they matter most.
GADx and LSTM would like to acknowledge funding from the NIHR HPRU for Emerging and Zoonotic diseases and The Pandemic Institute who made this programme possible.