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Clinical Validation of Isothermal Nucleic Acid Amplification Bioassays Modules - GUINEA

StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
This study aim to validate the clinical performances of two newly developed isothermal nucleic acid amplification bioassays modules for EBOV and LASV. Two retrospective studies will be conducted using biobanked patient samples such as plasma samples and buccal swabs already collected by the Centre de Recherche en Virologie, Laboratoire des Fièvres Hémorragiques Virales de Guinée (CRV-LFHVG) as part of their surveillance and outbreak activities. The diagnostic sensitivity and specificity of the EBOV and LASV bioassays modules 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 NCT07681752
Lead Sponsor Institute of Tropical Medicine, Belgium
Collaborators: National Center for Training and Research of Maferinyah, Guinea, Gamal Abdel Nasser University of Conakry
Conditions
(from sponsor)		 Ebola Hemorrhagic Fever, Lassa Hemorrhagic Fever
Related terms Hemorrhagic Fever, Ebola, Lassa Fever
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov