Clinical Validation of Isothermal Nucleic Acid Amplification Bioassays Modules - GUINEA

NCT07681752 | Not Yet Recruiting

• 3 other identifiers: 2020/26101137242101092049
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Assess sensitivity and specificity of the FORTIFIEDx and DECIPHER bioassays for EBOV and LASV

  The FORTIFIED assay gives qualitative results. The DECIPHER assay gives quantitative results for EBOV and LASV, which will be classified as positive or negative. It is assumed that a higher value indicates a higher viral load. The threshold for each pathogen 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 bioassays 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 (3)

LASV positives

Diagnostic Test: FORTIFIEDx and DECIPHER bioassays

EBOV positives

Diagnostic Test: FORTIFIEDx and DECIPHER bioassays

LASV and EBOV negatives

Diagnostic Test: FORTIFIEDx and DECIPHER bioassays

Interventions

FORTIFIEDx and DECIPHER bioassays DIAGNOSTIC_TEST

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

EBOV positives; LASV and EBOV negatives; LASV positives

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

EBOV and LASV biobanked patient samples already collected by the CRV-LFHVG and CNFRSR 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 and LASV test positive and negative biobanked patient samples

You may not qualify if:

• not applicable

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead
• National Center for Training and Research of Maferinyah, Guinea: collaborator
• Gamal Abdel Nasser University of Conakry: collaborator

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola; Lassa Fever

Condition Hierarchy (Ancestors)

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

Study Officials

• Karifa Kourouma, MD, MSc

  Centre National de Formation et de Recherche en Santé Rurale, Maferinyah, Guinea

  PRINCIPAL INVESTIGATOR

• Alimou Camara, Dr.

  Centre de Recherche en Virologie, Laboratoire des Fièvres Hémorragiques Virales de Guinée, Conakry, Guinea

  PRINCIPAL INVESTIGATOR

• Koen Vercauteren, Dr. Prof.

  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 2, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 2, 2026

Record last verified: 2026-06