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.
EBOV test positive and negative biobanked patient samples
not applicable
EBOV biobanked patient samples already collected by the INRB 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.
Case-control
Retrospective
DECIPHER bioassay
Diagnostic testDECIPHER bioassay, using recombinase polymerase amplification for a quantitative readout
Assess sensitivity and specificity of the DECIPHER bioassay for EBOV
The assay gives quantitative results for EBOV, which will be classified as positive or negative. It is assumed that a higher value indicates a higher viral load. The threshold 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.
Evaluate the usability of the bioassay 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.
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.
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Institute of Tropical Medicine, Belgium
Lead sponsor
Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
Collaborator
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