Clinical Validation of Isothermal Nucleic Acid Amplification Bioassays Modules - DRC
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The DECIPHER project aims to improve the diagnostic capacity for VHFs by developing a 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 the EBOV DECIPHER bioassay modules, two retrospective studies will be conducted using biobanked samples from patients previously tested for EBOV. These samples, collected by the INRB, 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 DECIPHER diagnostic tool. 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 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 investigators will evaluate the user-friendliness (by the laboratory technician) of the bioassay modules.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Koen Vercauteren, Prof. Dr.
- Telefonnummer: +32 3 247 63 32
- E-post: kvercauteren@itg.be
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- EBOV test positive and negative biobanked patient samples
Exclusion Criteria:
- not applicable
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
EBOV positives
|
DECIPHER bioassay, using recombinase polymerase amplification for a quantitative readout
|
|
EBOV negatives
|
DECIPHER bioassay, using recombinase polymerase amplification for a quantitative readout
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Assess sensitivity and specificity of the DECIPHER bioassay for EBOV
Tidsramme: Up to 1 year after the intervention
|
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.
|
Up to 1 year after the intervention
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Evaluate the usability of the bioassay by laboratory technicians - qualitative feedback
Tidsramme: Up to 1 year after the intervention
|
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.
|
Up to 1 year after the intervention
|
|
Evaluate the usability of the bioassay by laboratory technicians - quantitative feedback
Tidsramme: Up to 1 year after the intervention
|
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.
|
Up to 1 year after the intervention
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Placide Mbala, Prof., Institut National de Recherche Biomédicale, Kinshasa, Democratic Republic of the Congo
- Hovedetterforsker: Koen Vercauteren, Prof. Dr., Institute of Tropical Medicine, Antwerp, Belgium
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2019/26
- 101137242 (Annet stipend/finansieringsnummer: Horizon Europe)
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