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.
None
In the investigators opinion should not be enrolled onto study (e.g., medical prudence or capacity)
Single group
Rapid Diagnostic Test
DeviceThe 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.
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
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.
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.
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)
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.
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
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Liverpool School of Tropical Medicine
Lead sponsor
Medical Research Council
Collaborator
MEDEX
Collaborator
Mologic Ltd
Collaborator
