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Clinical Validation of Isothermal Nucleic Acid Amplification Bioassays Modules - GUINEA

NCT07681752 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2026-07-02

No results posted yet for this study

Summary

This study aim to validate the clinical performances of two newly developed isothermal nucleic acid amplification bioassays modules for EBOV and LASV. Two retrospective studies will be conducted using biobanked patient samples such as plasma samples and buccal swabs already collected by the Centre de Recherche en Virologie, Laboratoire des Fièvres Hémorragiques Virales de Guinée (CRV-LFHVG) as part of their surveillance and outbreak activities. The diagnostic sensitivity and specificity of the EBOV and LASV bioassays modules 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
  • Lassa Hemorrhagic Fever

Interventions

DIAGNOSTIC_TEST

FORTIFIEDx and DECIPHER bioassays

FORTIFIEDx bioassay, using recombinase polymerase amplification for a qualitative readout and DECIPHER bioassay, using recombinase polymerase amplification for a quantitative readout

Sponsors & Collaborators

  • National Center for Training and Research of Maferinyah, Guinea

    collaborator UNKNOWN

  • Gamal Abdel Nasser University of Conakry

    collaborator OTHER

  • Institute of Tropical Medicine, Belgium

    lead OTHER

Principal Investigators

  • Karifa Kourouma, MD, MSc · Centre National de Formation et de Recherche en Santé Rurale, Maferinyah, Guinea

  • Alimou Camara, Dr. · Centre de Recherche en Virologie, Laboratoire des Fièvres Hémorragiques Virales de Guinée, Conakry, Guinea

  • Koen Vercauteren, Dr. Prof. · 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 NCT07681752 on ClinicalTrials.gov