Clinical Validation of Isothermal Nucleic Acid Amplification Bioassays Modules - DRC
Clinical Validation of Isothermal Nucleic Acid Amplification Bioassays Modules - DRC
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.
The DECIPHER project aims to improve the diagnostic capacity for VHFs by developing a novel POC diagnostic tools capable of detecting EBOV and LASV. These tools are designed to enhance diagnostic sensitivity and specificity compared to existing rapid diagnostic solutions, thereby enabling faster and more accurate case detection. Improved diagnostic performance is expected to lead to better patient care and more effective outbreak control. Additionally, it aims to minimize healthcare worker's exposure to contaminated bodily fluids by supporting self-testing with healthcare worker assistance.
To validate the clinical performance of the EBOV DECIPHER bioassay modules, two retrospective studies will be conducted using biobanked samples from patients previously tested for EBOV. These samples, collected by the INRB, include both test-positive and test-negative cases confirmed by gold-standard RT-PCR assays. These studies are crucial steps in the evaluation of the DECIPHER diagnostic tool. Leveraging existing biobanked samples allows for the generation of clinically relevant performance data without the need for new patient recruitment.
The primary objective is to estimate the sensitivity and specificity of the bioassay modules for EBOV compared to standard RT-PCR on biobanked patient samples. As a secondary objective, the investigators will evaluate other endpoints related to diagnostic accuracy and concordance (e.g. positive and negative predictive values) and the investigators will evaluate the user-friendliness (by the laboratory technician) of the bioassay modules.
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kvercauteren@itg.be+32 3 247 63 32