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NCT05144776

Evaluation of Hepatitis B Virus (HBV) DNA Test as Point of Care Tool

Evaluation of Novel Hepatitis B DNA Test From Capillary Blood at the Point-of-care as a Tool to Enhance Clinical Management
Kirby Institute·ClinicalTrials.gov·diagnostic testRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Hepatitis B
Drug/Device/Intervention
GeneXpert HBV DNA Viral Load Assay
Study type
Observational
Intervention type
diagnostic test
Sponsor & location
Primary sponsor
Kirby Institute
Location
Sydney,Sydney,Sydney, Australia
Timeline & enrollment
Phase
N/A
Start date
Nov 17, 2022
End date
Dec 01, 2026
Enrollment
300 participants
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
Acute hepatitis BAcute hepatitis B without delta-agent and without hepatic comaAcute delta-(super)infection in chronic hepatitis BChronic viral hepatitis B without delta-agentChronic viral hepatitis B without delta-agent : other and unspecified phase
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05144776
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.