About this trial
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.
Eligibility criteria
Qualifiers
None
Disqualifiers
In the investigators opinion should not be enrolled onto study (e.g., medical prudence or capacity)
Trial design
Treatments tested in this trial
- Rapid Diagnostic Test
Treatment groups
Sponsors and collaborators
Liverpool School of Tropical Medicine
Lead sponsor
Medical Research Council
Collaborator
MEDEX
Collaborator
Mologic Ltd
Collaborator