Evaluation of Hepatitis B Virus (HBV) DNA Test As Point of Care Tool
NCT ID: NCT05144776
Last Updated: 2025-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
268 participants
OBSERVATIONAL
2022-11-17
2024-06-05
Brief Summary
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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.
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Detailed Description
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The Xpert HBV cartridge will be adapted to use fingerstick capillary blood instead of processed whole blood, and it's performance measured against a gold standard venous blood HBV DNA assay. Dried Blood Spot HBV DNA testing performance will also be measured against the gold standard venous blood HBV DNA assay.
Secondary objectives of the study are to: 1) evaluate diagnostic performance of the Xpert® HBV Viral Load assay compared to standard of care testing, by patients' hepatitis B e-antigen status (among e-antigen positive and e-antigen negative patients). 2) Evaluate diagnostic performance of the Xpert® HBV Viral Load assay compared to standard of care testing, by HBV treatment status (among treatment naïve patients and those receiving treatment). 3) Evaluate diagnostic performance of the Xpert® HBV Viral Load assay compared to standard of care testing, by HBV DNA levels (among patients with HBV DNA \<20 IU/mL; between 20 and 2,000 IU/mL, between 2,000 and 20,000 IU/mL; between 20,000 and 200,000 IU/mL; and \>200,000 IU/mL).
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Chronic hepatitis B
300 patients diagnosed with chronic hepatitis B will be enrolled. A fingerstick HBV DNA test will be performed using the Xpert HBV Viral Load assay, and a dried blood spot sample will be collected which will be tested using a gold standard HBV DNA viral load assay. Both results will be compared against the HBV DNA viral load from standard of care venous blood using the gold standard HBV DNA viral load assy. Enrolment of HBV DNA undetectable participants will be capped at 100.
GeneXpert HBV DNA Viral Load Assay
The Xpert venous blood HBV DNA viral load assay will be adapted to operate using fingerstick capillary blood samples.
Dried Blood Spot HBV DNA test
HBV DNA viral load will be measured from a fingerstick capillary dried blood spot sample using a gold standard HBV DNA viral load assay
Interventions
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GeneXpert HBV DNA Viral Load Assay
The Xpert venous blood HBV DNA viral load assay will be adapted to operate using fingerstick capillary blood samples.
Dried Blood Spot HBV DNA test
HBV DNA viral load will be measured from a fingerstick capillary dried blood spot sample using a gold standard HBV DNA viral load assay
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Kirby Institute
OTHER_GOV
Responsible Party
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Principal Investigators
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Gail V Matthews, MBChB
Role: PRINCIPAL_INVESTIGATOR
The Kirby Institute, University of New South Wales Australia
Locations
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St Vincent's Hospital
Sydney, New South Wales, Australia
Prince of Wales Hospital
Sydney, New South Wales, Australia
STORR Liver Centre Westmead Hospital
Sydney, New South Wales, Australia
Blacktown Hospital
Sydney, New South Wales, Australia
Liverpool Hospital
Sydney, New South Wales, Australia
St Vincent's Hospital Melbourne
Melbourne, Victoria, Australia
Countries
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Other Identifiers
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VHCRP 2103
Identifier Type: -
Identifier Source: org_study_id
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