Crimean-Congo haemorrhagic fever (CCHF) remains one of the world’s most pressing yet under-addressed infectious disease threats. Classified as a priority pathogen by the World Health Organization (WHO), CCHF is associated with high case fatality rates, limited treatment options, and a critical lack of accessible diagnostics. Together, these challenges have historically constrained timely clinical intervention and contributed to poor patient outcomes, particularly in endemic regions.
At present, treatment options for CCHF are limited. While ribavirin has demonstrated antiviral efficacy, its impact is highly dependent on early administration. This creates a narrow therapeutic window, and one that is frequently missed due to delays in diagnosis. The current gold standard diagnostic method, polymerase chain reaction (PCR), typically requires 2–5 days to return results. In many settings, especially those with limited laboratory infrastructure, this delay significantly impedes clinical decision-making and infection control efforts.
Recognising this gap, the WHO has identified the development of rapid diagnostic tests (RDTs) for CCHF as a global priority. Rapid, point-of-care diagnostics offer the potential to transform patient pathways by enabling immediate clinical decisions, earlier treatment initiation, and improved outbreak containment.
In response to this need, researchers at the Liverpool School of Tropical Medicine (LSTM) developed an initial proof-of-concept RDT, supported by funding from the National Institute for Health and Care Research Health Protection Research Unit in Emerging Zoonotic Infections and The Pandemics Institute. This early-stage innovation laid the groundwork for a transformative diagnostic solution.
Over the past two years, Global Access Diagnostics has partnered with LSTM, Iraq Centres for Disease Control and Ministry of Health Turkey to translate this concept into a scalable and deployable product. Backed by funding from the Medical Research Council, this collaboration has successfully delivered the world’s first rapid diagnostic test capable of detecting CCHF viral antigens. Crucially, the test has demonstrated clinical sensitivity and specificity exceeding the minimum thresholds defined in the WHO Target Product Profile (TPP), marking a significant technical and clinical milestone. The test has been successful transferred for scaled pilot manufacturing, and the test deployed in prospective multi-site pre-clinical and usability studies. These trials are being conducted at the point of care, during the CCHF 2026 outbreak season, across secondary health clinics in hyperendemic regions of Turkey, with approximately 500 patients enrolled.
If these evaluations confirm initial findings, the LSTM-developed CCHF antigen RDT will move into full-scale manufacturing and regulatory submission. The programme aims to bring the test to market within 18 months, representing a significant acceleration in the availability of life-saving diagnostics for CCHF.
This phase is critical, not only to validate diagnostic performance in real-world conditions, but also to assess usability among frontline healthcare workers. Ease of use, rapid turnaround, and reliability in resource limited settings, and will ultimately determine the test’s success and scalability.
The implications of this work are substantial. By reducing diagnostic turnaround times from days to minutes, the RDT has the potential to enable earlier treatment, improve survival rates, and strengthen outbreak response capabilities. More broadly, it represents a model for how collaborative, translational research spanning academia, industry, and global health stakeholders can deliver tangible impact against high-priority infectious diseases.
In the fight against CCHF, rapid diagnostics are not merely a technical advancement, they are a critical tool for shifting outcomes. This initiative demonstrates that with targeted investment, expert strategic partnerships, and a focus on real-world deployment, it is possible to move the dial on care where it is needed most.