Evaluation of Hepatitis B Virus (HBV) DNA Test as Point of Care Tool - Trial NCT05144776
Access comprehensive clinical trial information for NCT05144776 through Pure Global AI's free database. This phase not specified trial is sponsored by Kirby Institute and is currently Recruiting. The study focuses on Hepatitis B. Target enrollment is 300 participants.
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Study Focus
Sponsor & Location
Kirby Institute
Timeline & Enrollment
N/A
Nov 17, 2022
Dec 01, 2026
Primary Outcome
Assess performance of Xpert HBV DNA viral load assay using novel fingerstick capillary blood collection and HBV DNA viral load using fingerstick capillary Dried Blood Spot sample collection.
Summary
This is a cross sectional observational study to asses the performance of two novel HBV DNA
 testing methodologies; a) dried blood spot sampling and b) fingerstick capillary blood using
 the Xpert® Hepatitis B Virus viral load assay. Both novel testing methodologies will be
 compared with venous blood tested using a gold standard HBV DNA assay. The sensitivity and
 specificity of the two novel testing will be evaluated.
 
 HBV viral load tests are essential to guide antiviral treatment eligibility and
 effectiveness. However, many people are unable to access these tests, particularly those
 living in remote or limited resources settings given high cost, or unavailable
 infrastructure. Simple, affordable and accessible HBV viral load tests are required to
 increase global access to HBV testing and treatment to meet the WHO HBV elimination targets.
 The GeneXpert Diagnostic Systems, the most common molecular point-of-care platform globally,
 has the potential to provide simple and affordable HBV viral load tests. Dried Blood Spot
 testing is also an affordable and accessible testing methodology particularly suited to
 remote and resource limited settings. This proof-of-concept study will assess the feasibility
 and diagnostic performance of Xpert® HBV Viral Load test and Dried Blood Spot testing for the
 quantitation of HBV DNA from fingerstick capillary samples.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05144776
Non-Device Trial