Development of a Rapid Diagnostic Test to Identify Crimean-Congo Haemorrhagic Fever At the Point-Of-Care
- Conditions
- Crimean-Congo Haemorrhagic Fever
- Registration Number
- NCT06624787
- Lead Sponsor
- Liverpool School of Tropical Medicine
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 492
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
- In the investigators opinion should not be enrolled onto study (e.g., medical prudence or capacity)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Sensitivity and Specificity 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) 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.
- Secondary Outcome Measures
Name Time Method Usability of RDT via questionnaires answered by end users. Once all questionnaires have been completed, and quality checked - this should occur upto a month after the last recruit 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. 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 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. 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 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. 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) Time from blood drawn to diagnostic result - (from upload to the MoH server, and from the site knowing the RT-PCR result)