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NOT YET RECRUITING
NCT07688083

Clinical Validation of Isothermal Nucleic Acid Amplification Bioassays Modules - DRC

Sponsor: Institute of Tropical Medicine, Belgium

View on ClinicalTrials.gov

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

Interventions

DIAGNOSTIC_TEST

DECIPHER bioassay

DECIPHER bioassay, using recombinase polymerase amplification for a quantitative readout