Clinical Validation of Isothermal Nucleic Acid Amplification Bioassays Modules - DRC

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ebola Hemorrhagic Fever
• Intervention / Treatment: Diagnostic test: DECIPHER bioassay

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Koen Vercauteren, Prof. Dr.; Phone Number: +32 3 247 63 32; Email: kvercauteren@itg.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• EBOV test positive and negative biobanked patient samples

Exclusion Criteria:

• not applicable

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
EBOV positives	Diagnostic test: DECIPHER bioassay; DECIPHER bioassay, using recombinase polymerase amplification for a quantitative readout
EBOV negatives	Diagnostic test: DECIPHER bioassay; DECIPHER bioassay, using recombinase polymerase amplification for a quantitative readout

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 1 year after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 1 year after the intervention
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.	Up to 1 year after the intervention

Collaborators and Investigators

• Sponsor: Institute of Tropical Medicine, Belgium
• Collaborators: Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
• Investigators: Principal Investigator: Placide Mbala, Prof., Institut National de Recherche Biomédicale, Kinshasa, Democratic Republic of the Congo; Principal Investigator: Koen Vercauteren, Prof. Dr., Institute of Tropical Medicine, Antwerp, Belgium

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: June 24, 2026
• First Submitted That Met QC Criteria: June 30, 2026
• First Posted (Actual): July 7, 2026

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: June 30, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; RNA Virus Infections; Virus Diseases; Hemorrhagic Fevers, Viral; Mononegavirales Infections; Filoviridae Infections; Hemorrhagic Fever, Ebola
• Other Study ID Numbers: 2019/26; 101137242 (Other Grant/Funding Number: Horizon Europe)