Development Of A Rapid Diagnostic Test To Identify Crimean-Congo Haemorrhagic Fever At The Point-Of-Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 492
- 试验地点
- 6
- 主要终点
- Sensitivity and Specificity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Operators performing the RT-PCR will be unaware to the RDT results. This removes bias of the RT-PCR and RDT results. The results of the RDTs will not be shared with the participants and the healthcare staff will be trained to not use the results, as the RDT is not an approved device for CCHF diagnosis. Participants will follow the local standard of care of CCHF diagnosis and management which dependent on the MoH RT-PCR result.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •In the investigators opinion should not be enrolled onto study (e.g., medical prudence or capacity)
结局指标
主要结局
Sensitivity and Specificity
时间窗: 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.
次要结局
- 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))