Clinical Validation of Isothermal Nucleic Acid Amplification Bioassays Modules - DRC

NCT07688083 | Not Yet Recruiting

• 2 other identifiers: 2019/26101137242
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Ebola Hemorrhagic Fever

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  Up to 1 year after the intervention

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

  Up to 1 year after the intervention

Study Arms (2)

EBOV positives

Diagnostic Test: DECIPHER bioassay

EBOV negatives

Diagnostic Test: DECIPHER bioassay

Interventions

DECIPHER bioassay DIAGNOSTIC_TEST

DECIPHER bioassay, using recombinase polymerase amplification for a quantitative readout

EBOV negatives; EBOV positives

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• EBOV test positive and negative biobanked patient samples

You may not qualify if:

• not applicable

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead
• Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo: collaborator

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, Viral; RNA Virus Infections; Virus Diseases; Infections; Filoviridae Infections; Mononegavirales Infections

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Koen Vercauteren, Prof. Dr.

CONTACT

+32 3 247 63 32; kvercauteren@itg.be

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 7, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 7, 2026

Record last verified: 2026-06