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Clinical Validation of Isothermal Nucleic Acid Amplification Bioassays Modules - DRC

NCT07688083 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-07-07

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

DECIPHER bioassay

DECIPHER bioassay, using recombinase polymerase amplification for a quantitative readout

Sponsors & Collaborators

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

    collaborator OTHER

  • Institute of Tropical Medicine, Belgium

    lead OTHER

Principal Investigators

  • Placide Mbala, Prof. · Institut National de Recherche Biomédicale, Kinshasa, Democratic Republic of the Congo

  • Koen Vercauteren, Prof. Dr. · Institute of Tropical Medicine, Antwerp, Belgium

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-31
Primary Completion
2027-12-31
Completion
2027-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07688083 on ClinicalTrials.gov