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Development and evaluation of an antigen targeting lateral flow test for Crimean-Congo Haemorrhagic Fever
Caitlin R Thompson1, Ilkay Bozkurt2, Yasemin Cosgun3
1Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.
Insights
A new Crimean-Congo Haemorrhagic Fever (CCHF) rapid diagnostic test (RDT) shows promise for point-of-care use. This antigen-targeting lateral flow immunoassay RDT demonstrated effective diagnostic capability in preliminary clinical evaluations.
Area of Science:
- Virology and Infectious Diseases
- Diagnostic Assay Development
- Public Health
Background:
- Crimean-Congo Haemorrhagic Fever (CCHF) is a severe viral illness with a high case fatality rate (5-25%).
- The World Health Organization has prioritized CCHF research and development due to its significant public health threat.
- Currently, no rapid diagnostic tests (RDTs) for CCHF are commercially available, highlighting a critical unmet need.
Purpose of the Study:
- To develop and evaluate a novel antigen-targeting lateral flow immunoassay (RDT) for the rapid diagnosis of CCHF.
- To assess the diagnostic performance of the developed CCHF RDT in clinical settings.
Main Methods:
- Development of an antigen-targeting lateral flow immunoassay for CCHF detection.
- Prospective collection and testing of clinical samples in Türkiye (July-October 2023).
- Retrospective analysis of stored samples from Iraq, with comparison to RT-qPCR assays.
Main Results:
- In Türkiye, the CCHF RDT achieved a sensitivity of 90.4% and specificity of 96.2% on prospective samples.
- Sensitivity was higher (92.9%) in samples with a cycle threshold (Ct) ≤30.
- In Iraq, retrospective analysis showed RDT sensitivity of 71.7% and specificity of 92.5%, with 82.2% sensitivity for Ct ≤30 samples.
Conclusions:
- The developed CCHF RDT demonstrated effective diagnostic capability in preliminary clinical evaluations.
- The RDT shows potential for point-of-care diagnostics, addressing the current lack of commercial availability.
- Further definitive evaluation is required to meet regulatory standards for commercialization.
Background:
Crimean-Congo Haemorrhagic Fever (CCHF) is a viral haemorrhagic fever with a case fatality rate of 5-25% that has been prioritised for research and development by the World Health Organisation. There are no CCHF rapid diagnostic tests (RDTs) commercially available. We describe the development and evaluation of an antigen-targeting lateral flow immunoassay RDT for CCHF.
Methods:
Prospective clinical samples were collected and tested between July and October 2023 in Türkiye. Retrospective stored samples were obtained from the Central Public Health Laboratory, Baghdad, Iraq. The sensitivity and specificity of the CCHF RDT was compared to reverse transcription quantitative polymerase chain reaction assays.
Findings:
On prospective clinical samples in Türkiye, the sensitivity and specificity of the CCHF RDT was 90.4% [95% CI 81.5-95.3%] (n = 73) and 96.2% [95% CI 87.0-99.3%] (n = 52), respectively with a sensitivity of 92.9% [95% CI 84.3-96.9%] (n = 70) in samples with a cycle threshold (Ct) ≤30. On retrospective stored samples in Iraq, sensitivity and specificity of the RDT was 71.7% [95% CI 59.2-81.5%] (n = 60) and 92.5% [95% CI 80.1-97.8%] (n = 40), respectively with a sensitivity of 82.2% [95% CI 68.7-90.7%] (n = 45) in samples of Ct ≤30.
Interpretation:
The CCHF RDT was an effective rapid diagnostic test in this preliminary clinical evaluation, showing this RDT has the potential diagnostic capability for use at the point-of-care. Definitive evaluation is now required to ensure the RDT meets the regulatory requirements for commercialisation.
Funding:
The Liverpool School of Tropical Medicine, National Institute for Health Research Health Protection Research Unit in Emerging Zoonotic Infections, The Medical Research Council and The Pandemic Institute.
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