Ebola Hemorrhagic FeverNCT07688083
Clinical Validation of Isothermal Nucleic Acid Amplification Bioassays Modules - DRC
An observational study of Ebola Hemorrhagic Fever, run by Institute of Tropical Medicine, Belgium.
Trial summary
This study aims to validate the clinical performance of a newly developed isothermal nucleic acid amplification bioassay module for EBOV. A retrospective studies will be conducted using biobanked patient samples such as plasma samples and buccal swabs already collected by the Institut National de Recherches… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ebola Hemorrhagic Fever
- What is being tested?
- DECIPHER bioassay
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Child, Adult, Older adult
Study population: EBOV biobanked patient samples already collected by the INRB as part of their surveillance and outbreak activities. The investigators will use samples with an approximate overall sex distribution of 50% female and 50% male.
Who may be able to join
- EBOV test positive and negative biobanked patient samples
Who cannot join
- not applicable
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study aims to validate the clinical performance of a newly developed isothermal nucleic acid amplification bioassay module for EBOV. A retrospective studies will be conducted using biobanked patient samples such as plasma samples and buccal swabs already collected by the Institut National de Recherches Biomédicales (INRB) in Kinshasa, DRC as part of their surveillance and outbreak activities. The diagnostic sensitivity and specificity of the EBOV bioassay module will be compared to the gold-standard reverse transcriptase polymerase chain reaction (RT-PCR) technologies used in the national reference lab.
Read the detailed description
The DECIPHER project aims to improve the diagnostic capacity for VHFs by developing a novel POC diagnostic tools capable of detecting EBOV and LASV. These tools are designed to enhance diagnostic sensitivity and specificity compared to existing rapid diagnostic solutions, thereby enabling faster and more accurate case detection. Improved diagnostic performance is expected to lead to better patient care and more effective outbreak control. Additionally, it aims to minimize healthcare worker's exposure to contaminated bodily fluids by supporting self-testing with healthcare worker assistance.
To validate the clinical performance of the EBOV DECIPHER bioassay modules, two retrospective studies will be conducted using biobanked samples from patients previously tested for EBOV. These samples, collected by the INRB, include both test-positive and test-negative cases confirmed by gold-standard RT-PCR assays. These studies are crucial steps in the evaluation of the DECIPHER diagnostic tool. Leveraging existing biobanked samples allows for the generation of clinically relevant performance data without the need for new patient recruitment.
The primary objective is to estimate the sensitivity and specificity of the bioassay modules for EBOV compared to standard RT-PCR on biobanked patient samples. As a secondary objective, the investigators will evaluate other endpoints related to diagnostic accuracy and concordance (e.g. positive and negative predictive values) and the investigators will evaluate the user-friendliness (by the laboratory technician) of the bioassay modules.
- Conditions
- Ebola Hemorrhagic Fever
- Being tested
- DECIPHER bioassay
- Medical subject headings
- Hemorrhagic Fever, Ebola
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DECIPHER bioassayDiagnostic test
DECIPHER bioassay, using recombinase polymerase amplification for a quantitative readout
| Study group | Role | What they receive |
|---|---|---|
| EBOV positives | Not described Receives: Diagnostic Test: DECIPHER bioassay | |
| EBOV negatives | Not described Receives: Diagnostic Test: DECIPHER bioassay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess sensitivity and specificity of the DECIPHER bioassay for EBOV
The assay gives quantitative results for EBOV, which will be classified as positive or negative. It is assumed that a higher value indicates a higher viral load. The threshold will be determined as follows: (1) the maximum threshold that achieves ≥80% sensitivity, (2) the minimum threshold that achieves ≥80% specificity, (3) the threshold that maximizes Youden's index and (4) the threshold that minimizes the Euclidean index. Note that approach (1) and (2) will give an unbiased estimate of sensitivity and specificity at these pre-specified thresholds, while approach (3) and (4) is expected to overestimate sensitivity and specificity. Sensitivity and specificity (together with their 95% Wilson CI) will be calculated using the observed number of true and false positives and negatives. Positive and negative predictive value will be estimated using the calculated sensitivity and specificity.
Measured: Up to 1 year after the intervention
Secondary outcomes (2)
Evaluate the usability of the bioassay by laboratory technicians - quantitative feedback
Responses from the standardized questionnaire completed by laboratory technicians will be analysed using descriptive statistics. Quantitative usability metrics (such as ease of use scores, time requirements, and satisfaction ratings) will be summarized using (cumulative) counts and percentages or using medians, quartiles and ranges as appropriate.
Measured: Up to 1 year after the intervention
Evaluate the usability of the bioassay by laboratory technicians - qualitative feedback
Responses from the standardized questionnaire completed by laboratory technicians will be analysed using descriptive statistics. Qualitative feedback regarding workflow integration, clarity of instructions, and implementation challenges will be categorized and analysed thematically to identify common patterns and areas for improvement in the bioassay system design and user interface.
Measured: Up to 1 year after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study startJan 2027 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ebola Hemorrhagic FeverStudies 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-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de Recherche Biomedicale (INRB)
- Responsible party
- Sponsor
- Investigators
- Placide Mbala, Prof., Principal investigator, Institut National de Recherche Biomédicale, Kinshasa, Democratic Republic of the CongoKoen Vercauteren, Prof. Dr., Principal investigator, Institute of Tropical Medicine, Antwerp, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688083
- Sponsor's protocol ID
- 2019/26
- Other IDs
- 101137242
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of Isothermal Nucleic Acid Amplification Bioassays Modules - DRC
- ClinicalTrials.gov ID
- NCT07688083
- Acronym / sponsor ID
- 2019/26
- Conditions
- Ebola Hemorrhagic Fever
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- Institut National de Recherche Biomedicale (INRB)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 7 Jul 2026 (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.
This study aims to validate the clinical performance of a newly developed isothermal nucleic acid amplification bioassay module for EBOV. A retrospective studies will be conducted using biobanked patient samples such as plasma samples and buccal swabs already collected by the Institut National de Recherches Biomédicales (INRB) in Kinshasa, DRC as part of their surveillance and outbreak activities. The diagnostic sensitivity and specificity of the EBOV bioassay module will be compared to the gold-standard reverse transcriptase polymerase chain reaction (RT-PCR) technologies used in the national reference lab.
Detailed description
The DECIPHER project aims to improve the diagnostic capacity for VHFs by developing a novel POC diagnostic tools capable of detecting EBOV and LASV. These tools are designed to enhance diagnostic sensitivity and specificity compared to existing rapid diagnostic solutions, thereby enabling faster and more accurate case detection. Improved diagnostic performance is expected to lead to better patient care and more effective outbreak control. Additionally, it aims to minimize healthcare worker's exposure to contaminated bodily fluids by supporting self-testing with healthcare worker assistance.
To validate the clinical performance of the EBOV DECIPHER bioassay modules, two retrospective studies will be conducted using biobanked samples from patients previously tested for EBOV. These samples, collected by the INRB, include both test-positive and test-negative cases confirmed by gold-standard RT-PCR assays. These studies are crucial steps in the evaluation of the DECIPHER diagnostic tool. Leveraging existing biobanked samples allows for the generation of clinically relevant performance data without the need for new patient recruitment.
The primary objective is to estimate the sensitivity and specificity of the bioassay modules for EBOV compared to standard RT-PCR on biobanked patient samples. As a secondary objective, the investigators will evaluate other endpoints related to diagnostic accuracy and concordance (e.g. positive and negative predictive values) and the investigators will evaluate the user-friendliness (by the laboratory technician) of the bioassay modules.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EBOV positives | – | Diagnostic Test: DECIPHER bioassay |
| EBOV negatives | – | Diagnostic Test: DECIPHER bioassay |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- EBOV biobanked patient samples already collected by the INRB as part of their surveillance and outbreak activities. The investigators will use samples with an approximate overall sex distribution of 50% female and 50% male.
Key inclusion criteria (1 listed)
- EBOV test positive and negative biobanked patient samples
Key exclusion criteria (1 listed)
- not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DECIPHER bioassayDECIPHER bioassay, using recombinase polymerase amplification for a quantitative readout | Diagnostic test | EBOV negatives, EBOV positives |
Primary outcome
Assess sensitivity and specificity of the DECIPHER bioassay for EBOV
Time frame: Up to 1 year after the intervention
The assay gives quantitative results for EBOV, which will be classified as positive or negative. It is assumed that a higher value indicates a higher viral load. The threshold will be determined as follows: (1) the maximum threshold that achieves ≥80% sensitivity, (2) the minimum threshold that achieves ≥80% specificity, (3) the threshold that maximizes Youden's index and (4) the threshold that minimizes the Euclidean index. Note that approach (1) and (2) will give an unbiased estimate of sensitivity and specificity at these pre-specified thresholds, while approach (3) and (4) is expected to overestimate sensitivity and specificity. Sensitivity and specificity (together with their 95% Wilson CI) will be calculated using the observed number of true and false positives and negatives. Positive and negative predictive value will be estimated using the calculated sensitivity and specificity.
2 secondary outcomes
Evaluate the usability of the bioassay by laboratory technicians - quantitative feedback
Time frame: Up to 1 year after the intervention
Evaluate the usability of the bioassay by laboratory technicians - qualitative feedback
Time frame: Up to 1 year after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
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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.
Placide Mbala, Prof. principal investigator
Institut National de Recherche Biomédicale, Kinshasa, Democratic Republic of the Congo
Koen Vercauteren, Prof. Dr. principal investigator
Institute of Tropical Medicine, Antwerp, Belgium
Questions about this trial
What is this clinical trial studying?
An observational study of Ebola Hemorrhagic Fever, run by Institute of Tropical Medicine, Belgium.
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 1 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: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Koen Vercauteren, Prof. Dr. (+32 3 247 63 32, kvercauteren@itg.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess sensitivity and specificity of the DECIPHER bioassay for EBOV (time frame: Up to 1 year after the intervention). 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 7 Jul 2026.