Crimean-Congo Haemorrhagic Fever
Conditions
Keywords
CCHF, Medical Device, Lateral Flow, Rapid Diagnostic Test, LFT, RDT
Brief summary
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.
Interventions
DEVICERapid Diagnostic Test
The Liverpool School of Tropical Medicine (LSTM) in collaboration with Global Access Diagnostics (GADx) have achieved the development of the first RDT to detect CCHF viral antigens with a sensitivity and specificity that exceeds the minimum recommendation in the WHO target product profile (TPP)of \>80% and \>90% for sensitivity and specificity respectively for minimal performance in pre-clinical studies. The RDT is not only faster providing a test result within 20 minutes, but is also substantially cheaper than RT-PCR, and simpler to perform. A predicted price per test of around $5, whereas the current price of the RT-PCR test ranges from $1,000 to $1,200 for 96 reactions. The RDT does not require refrigeration or require specialist personnel to undertake, and the only additional apparatus needed is a stopwatch to monitor running time.
Sponsors
Liverpool School of Tropical Medicine
Medical Research Council
MEDEX
Mologic Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
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.
Intervention model description
A diagnostic evaluation study where each participant undergoes both reference testing and the diagnostic testing
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and Specificity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 ease of use of the RDT at the point of care in CCHF-endemic settings by end users answering a questionnaire designed with a 5-point Likert scale |
| 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 sensitivity, specificity, ease-of-use questionnaires, Positive predictive value, Negative predictive value and accuracy of RDT in all matrices to determine the most suitable matrix(ices) at the end-user setting. |
| 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 Positive predictive value (PPV), Negative predictive value (NPV) and Accuracy of the RDT in all matrices. |
| 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) | Time from blood drawn to diagnostic result - (from upload to the MoH server, and from the site knowing the RT-PCR result) |
Contacts
CONTACTRavi Lad
CONTACTAna Cubas Atienzar, PhD
Outcome results
None listed