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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLiverpool School of Tropical Medicine

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

No treatment groups listed

Sponsors and collaborators

Liverpool School of Tropical Medicine

Lead sponsor

Medical Research Council

Collaborator

MEDEX

Collaborator

Mologic Ltd

Collaborator