Clinical Validation of Isothermal Nucleic Acid Amplification Bioassays Modules - GUINEA
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FORTIFIEDx and DECIPHER bioassays.
- Who it may be relevant to
- Registry conditions: Ebola Hemorrhagic Fever, Lassa Hemorrhagic Fever. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
The FORTIFIEDx \& DECIPHER projects aim to improve the diagnostic capacity for VHFs by developing two 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 both the FORTIFIEDx and DECIPHER bioassays modules, two retrospective studies will be conducted using biobanked plasma samples and/ or buccal swabs from patients previously tested for EBOV and LASV. These samples, collected by the CRV-LFHVG, 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 FORTIFIEDx \& DECIPHER diagnostic tools. 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 LASV and 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 inverstigators will evaluate the user-friendliness (by the laboratory technician) of the bioassay modules.
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
Primary outcome measures
- Assess sensitivity and specificity of the FORTIFIEDx and DECIPHER bioassays for EBOV and LASV [Time frame: Up to 1 year after the intervention]
Secondary outcome measures (2)
- Evaluate the usability of the bioassays by laboratory technicians - quantitative feedback [Time frame: Up to 1 year after the intervention]
- Evaluate the usability of the bioassay by laboratory technicians - qualitative feedback [Time frame: Up to 1 year after the intervention]
Eligibility criteria
Inclusion criteria
- EBOV and LASV test positive and negative biobanked patient samples
Exclusion criteria
- not applicable
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-control
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07681752 · 2020/26 · 101137242 · 101092049