Clinical Validation of Isothermal Nucleic Acid Amplification Bioassays Modules - GUINEA
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorInstitute of Tropical Medicine, Belgium
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
EBOV and LASV test positive and negative biobanked patient samples
Disqualifiers
not applicable
Trial 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.
Trial design
Design model
Case-control
Time perspective
Retrospective
Treatments tested in this trial
FORTIFIEDx and DECIPHER bioassays
Diagnostic testFORTIFIEDx bioassay, using recombinase polymerase amplification for a qualitative readout and DECIPHER bioassay, using recombinase polymerase amplification for a quantitative readout
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: LASV positives1 intervention
Group B: EBOV positives1 intervention
Group C: LASV and EBOV negatives1 intervention
Trial outcomes
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.
Time frame
Up to 1 year after the interventionSecondary outcomes
1
Evaluate the usability of the bioassays by laboratory technicians - quantitative feedback
Responses from the standardized questionnaire completed by laboratory technicians will be analysed using descriptive statistics. Quantitative usability metrics (such as ease of use scores, time requirements, and satisfaction ratings) will be summarized using (cumulative) counts and percentages or using medians, quartiles and ranges as appropriate.
Time frame
Up to 1 year after the intervention2
Evaluate the usability of the bioassay by laboratory technicians - qualitative feedback
Responses from the standardized questionnaire completed by laboratory technicians will be analysed using descriptive statistics. Qualitative feedback regarding workflow integration, clarity of instructions, and implementation challenges will be categorized and analysed thematically to identify common patterns and areas for improvement in the bioassay system design and user interface.
Time frame
Up to 1 year after the interventionLocations
Sponsors and contacts
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Institute of Tropical Medicine, Belgium
Lead sponsor
National Center for Training and Research of Maferinyah, Guinea
Collaborator
Gamal Abdel Nasser University of Conakry
Collaborator
Source ClinicalTrials.gov
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