Background Crimean-Congo Haemorrhagic Fever (CCHF) is a rare disease with a death rate between 10% and 50%, rising to 80% during outbreaks. There are no approved drugs or vaccines, and existing treatments only work if given early. Current diagnosis is slow (2-5 days), delaying treatment, increasing risks, and heightening the chance of other people being infected. The WHO has prioritized developing rapid diagnostic tests (RDTs) to address these issues.
In regions like Afghanistan and Pakistan, delayed diagnosis is especially dangerous, particularly for pregnant women who cannot access emergency care until results are available. To tackle this, the Liverpool School of Tropical Medicine (LSTM) and Global Access Diagnostics (GADx) have created an RDT prototype to detect CCHF viral antigens. Initial testing in Türkiye (2024) showed promising accuracy, meeting WHO's basic standards but further testing is needed to confirm its reliability, especially with fresh samples.
Aims This study will evaluate the RDT using 200 fresh blood and serum samples during the 2025 CCHF season in Türkiye (Sivas and Samsun). If the test meets WHO standards, a clinical trial with 492 patients in CCHF-endemic areas of Türkiye will follow in 2026 to support regulatory approval (CE IVDR and UKCA certification).
Methods Researchers will test 200 fresh samples for diagnostic accuracy and evaluate the impact of storage conditions. This study aims to improve the test's accuracy and stability. Success will advance the development of a fast, reliable diagnostic tool for better CCHF detection and patient care in affected regions.
Willing to give whole blood samples (in a serum tube and EDTA tube) suspected of CCHF from Türkiye, Department of Infectious Diseases and Clinical Microbiology, Medical Faculty, Sivas Cumhuriyet University, Sivas or the department of Infectious Diseases or Ondokuz Mayis University (OMU) Faculty of Medicine, Department of Clinical Microbiology and Infectious Diseases, Samsun, that have not been frozen or refrigerated.
Adults aged 18 or over.
None
Participants suspected of CCHF infection requiring a standard of care test.
Case-only
Prospective
Not listed
Diagnostic Accuracy of the RDT
The principal objective of this study is to evaluate the diagnostic accuracy (novel RDT against RT-PCR) of the RDT using well-characterised fresh whole blood and serum samples from 200 CCHF suspected patients at the point of care.
Sequencing of positive RT-PCR samples
To sequence using MinION (Oxford Nanopore Technologies) for all RT-PCR positive (in at least one of the 3 PCRs selected) below a Ct count of 30. This objective aims to evaluate the sensitivity of the RDT in different CCHF strains.
Survival status of participants
To obtain survival data on those infected with CCHF, to evaluate the use of the RDT on severe cases.
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Liverpool School of Tropical Medicine
Lead sponsor
Ondokuz Mayıs University
Collaborator
Cumhuriyet University
Collaborator
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