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.

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Key information

Conditions

Ebola Hemorrhagic Fever Filoviridae Infections Hemorrhagic Fever, Ebola Hemorrhagic Fevers, Viral Infections Mononegavirales Infections RNA Virus Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

EBOV test positive and negative biobanked patient samples

Exclusion criteria

not applicable

Treatment and study plan

DECIPHER bioassay

Diagnostic Test

DECIPHER bioassay, using recombinase polymerase amplification for a quantitative readout

Primary outcomes

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.

Secondary outcomes

Evaluate the usability of the bioassay by laboratory technicians - quantitative feedback

Time frame: Up to 1 year after the intervention

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.
Evaluate the usability of the bioassay by laboratory technicians - qualitative feedback

Time frame: Up to 1 year after the intervention

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Koen Vercauteren, Prof. Dr.

CONTACT

[email protected]

+32 3 247 63 32

Sponsors and collaborators

Lead sponsor

Institute of Tropical Medicine, Belgium

Other

Collaborators

Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo

Registry information

Important dates

Study start: 2027
Primary completion: 2027
Study completion: 2027
First posted: Jul 7, 2026
Registry last updated: Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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