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

NCT05144776 | Completed

• 1 other identifier: VHCRP 2103
• Study Type: observational
• Target: 268
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Hepatitis B

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (3)

• Evaluate diagnostic performance of the novel tests by hepatitis B e-antigen status

  At completion of enrolment

• Evaluate diagnostic performance of the novel tests by HBV treatment status

  At completion of enrolment

• Evaluate diagnostic performance of the novel tests by HBV DNA levels

  At completion of enrolment

Study Arms (1)

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; Diagnostic Test: Dried Blood Spot HBV DNA test

Interventions

GeneXpert HBV DNA Viral Load Assay DIAGNOSTIC_TEST

The Xpert venous blood HBV DNA viral load assay will be adapted to operate using fingerstick capillary blood samples.

Chronic hepatitis B

Dried Blood Spot HBV DNA test DIAGNOSTIC_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

Chronic hepatitis B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Nil

Sponsors & Collaborators

• Kirby Institute: lead

Study Sites (6)

St Vincent's Hospital

Sydney, New South Wales, 2010, Australia

Location

Prince of Wales Hospital

Sydney, New South Wales, 2031, Australia

Location

STORR Liver Centre Westmead Hospital

Sydney, New South Wales, 2145, Australia

Location

Blacktown Hospital

Sydney, New South Wales, 2148, Australia

Location

Liverpool Hospital

Sydney, New South Wales, 2170, Australia

Location

St Vincent's Hospital Melbourne

Melbourne, Victoria, 3065, Australia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Dried blood spot samples will collected, tested for HBV viral load and remaining samples stored for future unspecified ethically approved HBV research.

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Gail V Matthews, MBChB

  The Kirby Institute, University of New South Wales Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 3, 2021
• Study Start: November 17, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 5, 2024
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (6)