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

NCT06624787 | Not Yet Recruiting DMC

• 1 other identifier: LSTM 24-044
• Study Type: interventional
• Target: 492
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Crimean-Congo Haemorrhagic Fever

Keywords

CCHF; Medical Device; Lateral Flow; Rapid Diagnostic Test; LFT; RDT

Outcome Measures

Primary Outcomes (1)

• Sensitivity and Specificity

  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.

  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)

Secondary Outcomes (4)

• 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)

Other Outcomes (2)

• Exploratory Outcome 1 - To identify the types of clinical presentations in terms of SGS scores, symptomatic phases, and outcomes of CCHF in endemic areas of Turkey.

  From the date/time of blood draw of the first participant until all diagnostic results and clinical information has been received - this should occur unto a month after the last recruit

• Exploratory Outcome 2 - Sensitivity of the RDT among local strains. Indirectly, information on the CCHFV strains circulating in Turkey during 2025 CCHF season will be collected.

  From the date/time of blood draw of the first participant until all diagnostic results, clinical information and sequencing results have been received - this should occur upto 6 months after the last recruit

Interventions

Rapid Diagnostic Test DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• In the investigators opinion should not be enrolled onto study (e.g., medical prudence or capacity)

Sponsors & Collaborators

• Liverpool School of Tropical Medicine: lead
• MEDEX: collaborator
• Medical Research Council: collaborator
• Mologic Ltd: collaborator

MeSH Terms

Conditions

Hemorrhagic Fever, Crimean

Interventions

Rapid Diagnostic Tests

Condition Hierarchy (Ancestors)

Arbovirus Infections; Vector Borne Diseases; Infections; Tick-Borne Diseases; Virus Diseases; Bunyaviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Point-of-Care Testing; Point-of-Care Systems; Patient Care Management; Health Services Administration

Central Study Contacts

Ravi Lad

CONTACT

151 705 3364; ravi.lad@lstmed.ac.uk

Ana Cubas Atienzar, PhD

CONTACT

151 705 3364; Ana.CubasAtienzar@lstmed.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A diagnostic evaluation study where each participant undergoes both reference testing and the diagnostic testing

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: October 3, 2024
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02