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Clinical Validation of Isothermal Nucleic Acid Amplification Bioassays Modules - DRC
Sponsor: Institute of Tropical Medicine, Belgium
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 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.
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2027-01
Completion Date
2027-12
Last Updated
2026-07-07
Healthy Volunteers
Not specified
Conditions
Interventions
DECIPHER bioassay
DECIPHER bioassay, using recombinase polymerase amplification for a quantitative readout