Clinical Validation of Isothermal Nucleic Acid Amplification Bioassays Modules - GUINEA

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorInstitute of Tropical Medicine, Belgium

About this trial

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.

Eligibility criteria

Qualifiers

EBOV and LASV test positive and negative biobanked patient samples

Disqualifiers

not applicable

Trial design

Treatments tested in this trial

  • FORTIFIEDx and DECIPHER bioassays

Treatment groups

150 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Institute of Tropical Medicine, Belgium

Lead sponsor

National Center for Training and Research of Maferinyah, Guinea

Collaborator

Gamal Abdel Nasser University of Conakry

Collaborator