An interventional study of Rapid Diagnostic Test in Crimean-Congo Haemorrhagic Fever, sponsored by Liverpool School of Tropical Medicine. Recruiting at 6 sites in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by Liverpool School of Tropical Medicine · Not applicable, Interventional, and Diagnostic
The goal of this medical device diagnostic evaluation study is to determine if this novel lateral flow device can detect Crimean-Congo Hemorrhagic Fever (CCHF) at the point of care in secondary health care clinics in Turkey. The main outcome is to determine the sensitivity and specificity of the tests for CCHF in samples of whole blood, serum and capillary blood compared to a gold-standard of PCR for participants that present at 4 endemic sites secondary health care clinics in Turkey in 492 adults who are suspected to have been infected with CCHF. The study aims to hopes to achieve at least the minimum required sensitivity of 90 % and specificity of 80 % as required by the WHO.
Liverpool School of Tropical Medicine is the lead sponsor of 57 studies on the registry; 23 are open to participants now.
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Participants aged 18 years or older Suspected CCHF infection that requires a RT-PCR diagnosis and venous blood draw Willingness to comply with study procedures and consent to the study Presents at 1 of 4 listed sites
Exclusion Criteria:
The Liverpool School of Tropical Medicine (LSTM) in collaboration with Global Access Diagnostics (GADx) have achieved the development of the first RDT to detect CCHF viral antigens with a sensitivity and specificity that exceeds the minimum recommendation in the WHO target product profile (TPP)of \>80% and \>90% for sensitivity and specificity respectively for minimal performance in pre-clinical studies. The RDT is not only faster providing a test result within 20 minutes, but is also substantially cheaper than RT-PCR, and simpler to perform. A predicted price per test of around $5, whereas the current price of the RT-PCR test ranges from $1,000 to $1,200 for 96 reactions. The RDT does not require refrigeration or require specialist personnel to undertake, and the only additional apparatus needed is a stopwatch to monitor running time.
Sensitivity and Specificity
To determine the sensitivity and specificity of RDT tests for CCHF in samples of whole blood, serum and capillary blood compared to a gold-standard of PCR for participants that present at 4 endemic sites secondary health care clinics in Turkey.
Time frame: From the date/time of blood draw of the first participant until all diagnostic results have been received (up to two weeks from blood draw)
Usability of RDT via questionnaires answered by end users.
To determine the ease of use of the RDT at the point of care in CCHF-endemic settings by end users answering a questionnaire designed with a 5-point Likert scale
Time frame: Once all questionnaires have been completed, and quality checked - this should occur upto a month after the last recruit
To determine the most suitable matrices that have the minimum TPP as required by the WHO for RDTs for CCHF detection.
Using the sensitivity, specificity, ease-of-use questionnaires, Positive predictive value, Negative predictive value and accuracy of RDT in all matrices to determine the most suitable matrix(ices) at the end-user setting.
Time frame: From the date/time of blood draw of the first participant until all diagnostic results and questionnaires have been received - this should be completed upto a month after the last recruit
Using the PPV, NPV and accuracy of the RDT in all matrices.
To determine the Positive predictive value (PPV), Negative predictive value (NPV) and Accuracy of the RDT in all matrices.
Time frame: From the date/time of blood draw of the first participant until all diagnostic results have been received (up to two weeks from first blood draw of database lock)
To determine the time taken for a CCHF result from blood draw.
Time from blood drawn to diagnostic result - (from upload to the MoH server, and from the site knowing the RT-PCR result)
Time frame: From the date/time of blood draw of the first participant until all diagnostic results have been received (this should occur unto a month after the last recruit)
Exploratory Outcome 1 - To identify the types of clinical presentations in terms of SGS scores, symptomatic phases, and outcomes of CCHF in endemic areas of Turkey.
Sensitivity of the RDT among clinical, demographic, outcome subgroups of suspected CCHF-infected individuals in Turkey. Indirectly information of the clinical characteristics and demographics of the patients that require a CCHF diagnosis during 2025 CCHF in the selected clinics will be collected.
Time frame: From the date/time of blood draw of the first participant until all diagnostic results and clinical information has been received - this should occur unto a month after the last recruit
Exploratory Outcome 2 - Sensitivity of the RDT among local strains. Indirectly, information on the CCHFV strains circulating in Turkey during 2025 CCHF season will be collected.
Sequencing data on negative RDT results and PCR positive results to determine whether CCHFV strain has a negative impact on test sensitivity
Time frame: From the date/time of blood draw of the first participant until all diagnostic results, clinical information and sequencing results have been received - this should occur upto 6 months after the last recruit
Plan to share: Undecided
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Sep 2026, 4 months after the start.
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Hemorrhagic Fever, Crimean
Liverpool School of Tropical Medicine