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Clinical Validation of Isothermal Nucleic Acid Amplification Bioassays Modules - DRC

StatusNot Yet Recruiting
PhaseNot specified
Started
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Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07688083
Lead Sponsor Institute of Tropical Medicine, Belgium
Collaborators: Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
Conditions
(from sponsor)		 Ebola Hemorrhagic Fever
Related terms Hemorrhagic Fever, Ebola
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov