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

March 4, 2025 updated by: Kirby Institute

Evaluation of Novel Hepatitis B DNA Test from Capillary Blood At the Point-of-care As a Tool to Enhance Clinical Management

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will be a cross-sectional observational study and will assess the performance of a novel fingerstick HBV Viral Load and Dried Blood Spot tests within a total of 300 participants who will be recruited across a network of hepatitis clinics in Sydney, Australia. No treatment will be administered as part of this study.

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).

Study Type

Observational

Enrollment (Actual)

268

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2170
        • Liverpool Hospital
      • Sydney, New South Wales, Australia, 2010
        • St Vincent's Hospital
      • Sydney, New South Wales, Australia, 2031
        • Prince of Wales Hospital
      • Sydney, New South Wales, Australia, 2148
        • Blacktown Hospital
      • Sydney, New South Wales, Australia, 2145
        • STORR Liver Centre Westmead Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3065
        • St Vincent's Hospital Melbourne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited from across the network of tertiary hepatitis clinics active in providing HBV clinical care. All participants must meet the inclusion criteria to be eligible to participate in the study.

Participants will be recruited irrespective of HBV DNA Level, HBeAg or treatment status.

Description

Inclusion Criteria:

  • Have voluntarily signed the informed consent form, 18 years of age or older, HBsAg positive

Exclusion Criteria:

  • Nil

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: 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.
Diagnostic test: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: At completion of enrolment
Evaluate the diagnostic performance of the Xpert HBV viral load assay and DBS samples using fingerstick capillary blood compared with the gold standard venous blood HBV DNA viral load assay
At completion of enrolment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate diagnostic performance of the novel tests by hepatitis B e-antigen status
Time Frame: At completion of enrolment
Evaluate the diagnostic performance of the Xpert HBV viral load assay and DBS samples using fingerstick capillary blood compared with the gold standard venous blood HBV DNA viral load assay by 'Hepatitis B e-antigen status (among e-antigen positive and e-antigen negative patients).
At completion of enrolment
Evaluate diagnostic performance of the novel tests by HBV treatment status
Time Frame: At completion of enrolment
Evaluate the diagnostic performance of the Xpert HBV viral load assay and DBS samples using fingerstick capillary blood compared with the gold standard venous blood HBV DNA viral load assay by HBV treatment status (among treatment naïve patients and those receiving treatment)
At completion of enrolment
Evaluate diagnostic performance of the novel tests by HBV DNA levels
Time Frame: At completion of enrolment
Evaluate the diagnostic performance of the Xpert HBV viral load assay and DBS samples using fingerstick capillary blood compared with the gold standard venous blood HBV DNA viral load assay 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).
At completion of enrolment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kirby Institute

Investigators

  • Principal Investigator: Gail V Matthews, MBChB, The Kirby Institute, University of New South Wales Australia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2022

Primary Completion (Actual)

June 1, 2024

Study Completion (Actual)

June 5, 2024

Study Registration Dates

First Submitted

November 22, 2021

First Submitted That Met QC Criteria

November 22, 2021

First Posted (Actual)

December 3, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 4, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VHCRP 2103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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