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

RecruitingNAAges 18 Years - anyAllLiverpool School of Tropical Medicine
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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)
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What it tests

  • Rapid Diagnostic Test
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Where

6 sites
Atatürk University
Erzurum, Turkey (Türkiye)
Erzurum City Hospital
Erzurum, Turkey (Türkiye)
Kastamonu Üniversitesi
Kastamonu, Turkey (Türkiye)
Ondokuz Mayis University (OMU) Faculty of Medicine, Department of Clinical Microbiology and Infectious Diseases, Samsun
Samsun, Turkey (Türkiye)
Sivas Cumhuriyet University
Sivas, Turkey (Türkiye)
Tokat Gaziosmanpaşa University
Tokat Province, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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