Mobile Point of Care Diagnostic Testing for Ebola Virus Disease in DRC

NCT04235361 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2020-11-10

No results posted yet for this study

Summary

A mobile suitcase laboratory for EBOV point-of-care (POC) detection at Ebola treatment centers was successfully implemented in Guinea during the large Ebola virus disease (EVD) outbreak in West-Africa 2014-2015.

It was shown that isothermal amplification (Recombinase Polymerase Amplification (RPA)) could be efficiently used to test suspect EVD cases and local teams were trained in and successfully deployed with this fast method.

In the frame of this project we want to train teams in DRC and expand RPA testing capacity to the differentials recommended by the WHO. Existing RPA assays for all parameters will be included into a multistrip for simultaneous use. This will be integrated with a simple biosafe extraction method.

Implementing this approach and testing in the ongoing EVD outbreak will provide teams in DRC with response capacity for future EVD outbreaks.

Conditions

  • Ebola Virus Disease
  • Malaria
  • Typhoid Fever
  • Dengue Fever
  • Chikungunya Fever
  • Yellow Fever

Interventions

DIAGNOSTIC_TEST

Differential RPA tests

The mobile diagnostic suitcases will be deployed at Ebola Treatment centres in DRC. Samples of patients refered for diagnostic testing will be tested by PCR by existing diagnostic teams, and will be additionally tested by the mobile suitcase laboratory using differential RPA tests for 6 parameters.

Sponsors & Collaborators

  • Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo

    collaborator OTHER
  • Institut Pasteur de Dakar

    collaborator OTHER
  • University of Göttingen

    collaborator OTHER
  • Centre de Recheche du Centre Hospitalier Université Laval

    collaborator OTHER
  • University of Stirling

    lead OTHER

Principal Investigators

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-15
Primary Completion
2021-06-30
Completion
2021-07-30

Countries

  • Canada
  • Democratic Republic of the Congo
  • Germany
  • Senegal

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04235361 on ClinicalTrials.gov