Infectious Diseases, EmergingDETECT-R&DNCT06894758
Development of a Rapid Diagnostic Test to Identify Crimean-Congo Hemorrhagic Fever - Research and Development Testing
An observational study of Infectious Diseases, Emerging, run by Liverpool School of Tropical Medicine at 2 sites in Turkey (Türkiye).
Trial summary
Background Crimean-Congo Haemorrhagic Fever (CCHF) is a rare disease with a death rate between 10% and 50%, rising to 80% during outbreaks. There are no approved drugs or vaccines, and existing treatments only work if given early. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infectious Diseases, Emerging
- How many people
- 196 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 17 Jun 2025to 31 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants suspected of CCHF infection requiring a standard of care test.
Who may be able to join
- Willing to give whole blood samples (in a serum tube and EDTA tube) suspected of CCHF from Türkiye, Department of Infectious Diseases and Clinical Microbiology, Medical Faculty, Sivas Cumhuriyet University, Sivas or the department of Infectious Diseases or Ondokuz Mayis University (OMU) Faculty of Medicine, Department of Clinical Microbiology and Infectious Diseases, Samsun, that have not been frozen or refrigerated.
- Adults aged 18 or over.
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Ondokuz Mayis University (OMU) Faculty of Medicine, Department of Clinical Microbiology and Infectious Diseases, Samsun
Samsun, 55200
Department of Infectious Diseases and Clinical Microbiology, Medical Faculty, Sivas Cumhuriyet University, Sivas
Sivas, 58000
About this study
Official title: Development of a Rapid Diagnostic Test to Identify Crimean-Congo Haemorrhagic Fever at the Point-of-Care - Research and Development Testing
Background Crimean-Congo Haemorrhagic Fever (CCHF) is a rare disease with a death rate between 10% and 50%, rising to 80% during outbreaks. There are no approved drugs or vaccines, and existing treatments only work if given early. Current diagnosis is slow (2-5 days), delaying treatment, increasing risks, and heightening the chance of other people being infected. The WHO has prioritized developing rapid diagnostic tests (RDTs) to address these issues.
In regions like Afghanistan and Pakistan, delayed diagnosis is especially dangerous, particularly for pregnant women who cannot access emergency care until results are available. To tackle this, the Liverpool School of Tropical Medicine (LSTM) and Global Access Diagnostics (GADx) have created an RDT prototype to detect CCHF viral antigens. Initial testing in Türkiye (2024) showed promising accuracy, meeting WHO's basic standards but further testing is needed to confirm its reliability, especially with fresh samples.
Read more
Aims This study will evaluate the RDT using 200 fresh blood and serum samples during the 2025 CCHF season in Türkiye (Sivas and Samsun). If the test meets WHO standards, a clinical trial with 492 patients in CCHF-endemic areas of Türkiye will follow in 2026 to support regulatory approval (CE IVDR and UKCA certification).
Methods Researchers will test 200 fresh samples for diagnostic accuracy and evaluate the impact of storage conditions. This study aims to improve the test's accuracy and stability. Success will advance the development of a fast, reliable diagnostic tool for better CCHF detection and patient care in affected regions.
Read the detailed description
Background Crimean-Congo Haemorrhagic Fever (CCHF) is a life-threatening disease with a fatality rate ranging from 10% to 50%, and up to 80% in outbreaks. Despite its severity, there are no licensed drugs or vaccines available, and treatment options like Ribavirin are only effective if administered early. The current diagnostic method is slow, taking 2-5 days, which delays treatment, worsens patient outcomes, increases the risk of human-to-human transmission, and strains healthcare resources. Rapid diagnostic tests (RDTs) have been identified as a priority by the WHO to address these challenges.
Delays in diagnosis are particularly critical in regions such as Afghanistan and Pakistan, where suspected CCHF cases, especially among pregnant women, struggle to access emergency care until test results are available. The WHO R\&D Blueprint has emphasized the urgent need for point-of-care (POC) tests to reduce diagnosis time and improve patient management.
To meet this need, the Liverpool School of Tropical Medicine (LSTM) and Global Access Diagnostics (GADx) have developed an RDT prototype capable of detecting CCHF viral antigens. This prototype has demonstrated promising sensitivity and specificity, exceeding the WHO's target product profile (TPP) minimum requirements of >80% sensitivity and >90% specificity, with optimal performance defined as >90% sensitivity and >95% specificity. Initial tests in Türkiye in August 2024 showed the prototype achieving sensitivity of 81.2% in 38 prospective samples and 86.4% in 117 retrospective inactivated serum samples, with specificity between 95.5% and 98%.
Further testing in December 2024 with 770 frozen stored samples in Iraq and Türkiye yielded slightly lower performance, potentially due to the effects of freezing and thawing on sample integrity. We hypothesize that freezing alters gene expression, protein stability, and aggregation, impacting test accuracy. Therefore, additional testing with fresh, unfrozen samples is needed to confirm the RDT's reliability before progressing to clinical evaluation.
Aims This study aims to evaluate the RDT using 200 fresh samples collected during the 2025 CCHF season in Sivas and Samsun, Türkiye. If performance aligns with WHO TPP standards, a clinical trial involving 492 patients in CCHF-endemic regions of Türkiye is planned for 2026. The trial data will support regulatory submissions for CE IVDR and UKCA certification.
Methods Before launching the clinical trial, the investigators will conduct further diagnostic accuracy testing on 200 fresh samples (whole blood and serum) to ensure compliance with WHO TPP standards. These samples, pseudonymized and not used for patient management, will also undergo stability testing to assess the impact of storage conditions, including refrigeration for 72 hours (at Sivas site only) and freeze-thaw cycles.
By using optimized RDTs and fresh samples, we aim to improve sensitivity and specificity beyond previous results from December 2024. This study is critical for refining the test, ensuring its effectiveness, and providing essential data on device stability. Ultimately, this research will pave the way for a reliable, rapid diagnostic tool that can significantly enhance CCHF detection and patient outcomes in endemic regions.
- Conditions
- Infectious Diseases, Emerging
- Keywords
- CCHF, Rapid Diagnostic Test, Lateral Flow, RDT, Medical Device
- Medical subject headings
- Communicable Diseases, Emerging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All participants | All participants will suspected of CCHF infection who present at two hospital sites in Türkiye. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of the RDT
The principal objective of this study is to evaluate the diagnostic accuracy (novel RDT against RT-PCR) of the RDT using well-characterised fresh whole blood and serum samples from 200 CCHF suspected patients at the point of care.
Measured: RDT will be performed at the point-of-care and RT-PCR performed 5-7 days after blood draw.
Secondary outcomes (2)
Sequencing of positive RT-PCR samples
To sequence using MinION (Oxford Nanopore Technologies) for all RT-PCR positive (in at least one of the 3 PCRs selected) below a Ct count of 30. This objective aims to evaluate the sensitivity of the RDT in different CCHF strains.
Measured: This will be performed near to the end of the study at LSTM in a batch.
Survival status of participants
To obtain survival data on those infected with CCHF, to evaluate the use of the RDT on severe cases.
Measured: From enrolment to outcome of participant (discharge or death) up to 1 month post presentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start17 Jun 2025
- Primary completion10 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious Diseases, EmergingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool School of Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Ondokuz Mayıs University, Cumhuriyet University
- Responsible party
- Sponsor
- Investigators
- Ana Cubas Isabel Atienzar, PhD, Principal investigator, Liverpool School of Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06894758
- Sponsor's protocol ID
- LSTM 25-017
- Acronym
- DETECT-R&D
- Status last verified
- Aug 2026
- First submitted
- 12 Mar 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This data will be used in conjunction with next years trial for IVDR submission.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Rapid Diagnostic Test to Identify Crimean-Congo Haemorrhagic Fever at the Point-of-Care - Research and Development Testing
- ClinicalTrials.gov ID
- NCT06894758
- Acronym / sponsor ID
- DETECT-R&D / LSTM 25-017
- Conditions
- Infectious Diseases, Emerging
- Keywords
- CCHF, Rapid Diagnostic Test, Lateral Flow, RDT, Medical Device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Liverpool School of Tropical MedicineUniversity, hospital or other
- Collaborators
- Ondokuz Mayıs University, Cumhuriyet University
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background Crimean-Congo Haemorrhagic Fever (CCHF) is a rare disease with a death rate between 10% and 50%, rising to 80% during outbreaks. There are no approved drugs or vaccines, and existing treatments only work if given early. Current diagnosis is slow (2-5 days), delaying treatment, increasing risks, and heightening the chance of other people being infected. The WHO has prioritized developing rapid diagnostic tests (RDTs) to address these issues.
In regions like Afghanistan and Pakistan, delayed diagnosis is especially dangerous, particularly for pregnant women who cannot access emergency care until results are available. To tackle this, the Liverpool School of Tropical Medicine (LSTM) and Global Access Diagnostics (GADx) have created an RDT prototype to detect CCHF viral antigens. Initial testing in Türkiye (2024) showed promising accuracy, meeting WHO's basic standards but further testing is needed to confirm its reliability, especially with fresh samples.
Aims This study will evaluate the RDT using 200 fresh blood and serum samples during the 2025 CCHF season in Türkiye (Sivas and Samsun). If the test meets WHO standards, a clinical trial with 492 patients in CCHF-endemic areas of Türkiye will follow in 2026 to support regulatory approval (CE IVDR and UKCA certification).
Methods Researchers will test 200 fresh samples for diagnostic accuracy and evaluate the impact of storage conditions. This study aims to improve the test's accuracy and stability. Success will advance the development of a fast, reliable diagnostic tool for better CCHF detection and patient care in affected regions.
Detailed description
Background Crimean-Congo Haemorrhagic Fever (CCHF) is a life-threatening disease with a fatality rate ranging from 10% to 50%, and up to 80% in outbreaks. Despite its severity, there are no licensed drugs or vaccines available, and treatment options like Ribavirin are only effective if administered early. The current diagnostic method is slow, taking 2-5 days, which delays treatment, worsens patient outcomes, increases the risk of human-to-human transmission, and strains healthcare resources. Rapid diagnostic tests (RDTs) have been identified as a priority by the WHO to address these challenges.
Delays in diagnosis are particularly critical in regions such as Afghanistan and Pakistan, where suspected CCHF cases, especially among pregnant women, struggle to access emergency care until test results are available. The WHO R\&D Blueprint has emphasized the urgent need for point-of-care (POC) tests to reduce diagnosis time and improve patient management.
To meet this need, the Liverpool School of Tropical Medicine (LSTM) and Global Access Diagnostics (GADx) have developed an RDT prototype capable of detecting CCHF viral antigens. This prototype has demonstrated promising sensitivity and specificity, exceeding the WHO's target product profile (TPP) minimum requirements of >80% sensitivity and >90% specificity, with optimal performance defined as >90% sensitivity and >95% specificity. Initial tests in Türkiye in August 2024 showed the prototype achieving sensitivity of 81.2% in 38 prospective samples and 86.4% in 117 retrospective inactivated serum samples, with specificity between 95.5% and 98%.
Further testing in December 2024 with 770 frozen stored samples in Iraq and Türkiye yielded slightly lower performance, potentially due to the effects of freezing and thawing on sample integrity. We hypothesize that freezing alters gene expression, protein stability, and aggregation, impacting test accuracy. Therefore, additional testing with fresh, unfrozen samples is needed to confirm the RDT's reliability before progressing to clinical evaluation.
Aims This study aims to evaluate the RDT using 200 fresh samples collected during the 2025 CCHF season in Sivas and Samsun, Türkiye. If performance aligns with WHO TPP standards, a clinical trial involving 492 patients in CCHF-endemic regions of Türkiye is planned for 2026. The trial data will support regulatory submissions for CE IVDR and UKCA certification.
Methods Before launching the clinical trial, the investigators will conduct further diagnostic accuracy testing on 200 fresh samples (whole blood and serum) to ensure compliance with WHO TPP standards. These samples, pseudonymized and not used for patient management, will also undergo stability testing to assess the impact of storage conditions, including refrigeration for 72 hours (at Sivas site only) and freeze-thaw cycles.
By using optimized RDTs and fresh samples, we aim to improve sensitivity and specificity beyond previous results from December 2024. This study is critical for refining the test, ensuring its effectiveness, and providing essential data on device stability. Ultimately, this research will pave the way for a reliable, rapid diagnostic tool that can significantly enhance CCHF detection and patient outcomes in endemic regions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | – | –All participants will suspected of CCHF infection who present at two hospital sites in Türkiye. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants suspected of CCHF infection requiring a standard of care test.
Key inclusion criteria (2 listed)
- Willing to give whole blood samples (in a serum tube and EDTA tube) suspected of CCHF from Türkiye, Department of Infectious Diseases and Clinical Microbiology, Medical Faculty, Sivas Cumhuriyet University, Sivas or the department of Infectious Diseases or Ondokuz Mayis University (OMU) Faculty of Medicine, Department of Clinical Microbiology and Infectious Diseases, Samsun, that have not been frozen or refrigerated.
- Adults aged 18 or over.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Accuracy of the RDT
Time frame: RDT will be performed at the point-of-care and RT-PCR performed 5-7 days after blood draw.
The principal objective of this study is to evaluate the diagnostic accuracy (novel RDT against RT-PCR) of the RDT using well-characterised fresh whole blood and serum samples from 200 CCHF suspected patients at the point of care.
2 secondary outcomes
Sequencing of positive RT-PCR samples
Time frame: This will be performed near to the end of the study at LSTM in a batch.
Survival status of participants
Time frame: From enrolment to outcome of participant (discharge or death) up to 1 month post presentation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No. This data will be used in conjunction with next years trial for IVDR submission.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Cubas Isabel Atienzar, PhD principal investigator
Liverpool School of Tropical Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infectious Diseases, Emerging, run by Liverpool School of Tropical Medicine at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of the RDT (time frame: RDT will be performed at the point-of-care and RT-PCR performed 5-7 days after blood draw.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.