Clinical Trial: Clinical Validation of Isothermal Nucleic Acid Amplification Bioassays Modules - DRC

U.S., July 8 -- ClinicalTrials.gov registry received information related to the study (NCT07688083) titled 'Clinical Validation of Isothermal Nucleic Acid Amplification Bioassays Modules - DRC' on June 24.

Brief Summary: 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 Biomedicales (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 transcript...