Evaluating a Rapid Diagnostic Device to Detect Crimean-Congo Hemorrhagic Fever at Clinics in Turkey

What this Trial Is About

Researchers are evaluating a novel rapid diagnostic device designed to detect Crimean-Congo Hemorrhagic Fever CCHF at the point of care in secondary health care clinics in Turkey. This study aims to determine the sensitivity and specificity of the test using samples of whole blood, serum, and capillary blood from adults suspected of CCHF infection. The goal is to meet or exceed the World Health Organizations minimum sensitivity of 90% and specificity of 80% for this condition. The study involves using a rapid diagnostic test RDT developed by the Liverpool School of Tropical Medicine and Global Access Diagnostics. This device detects CCHF viral antigens quicklyproviding results within 20 minutesand is simpler and more affordable than the standard RT-PCR test. Participants suspected of infection will have blood drawn and tested with the RDT at four endemic secondary health care sites in Turkey. Participants will provide blood samples which will be compared against PCR testing to evaluate the accuracy of the new device. The study will also collect questionnaires from end users to assess usability. Researchers will measure diagnostic sensitivity, specificity, predictive values, test accuracy, and the time taken to obtain results. The study includes follow-up until all diagnostic results and questionnaires are received, which may take up to a month after the last participant is recruited.

Development Of A Rapid Diagnostic Test To Identify Crimean-Congo Haemorrhagic Fever At The Point-Of-Care