Development Of A Rapid Diagnostic Test To Identify Crimean-Congo Haemorrhagic Fever At The Point-Of-Care
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Crimean-Congo Haemorrhagic Fever
- Sponsor
- Liverpool School of Tropical Medicine
- Enrollment
- 492
- Primary Endpoint
- Sensitivity and Specificity
- Status
- Not Yet Recruiting
- Last Updated
- 2 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •In the investigators opinion should not be enrolled onto study (e.g., medical prudence or capacity)
Outcomes
Primary Outcomes
Sensitivity and Specificity
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)
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 Outcomes
- 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 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 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 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))