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

Hepatitis B Clinical Trial

— HBVPOCT  

Official title:

Evaluation of Novel Hepatitis B DNA Test From Capillary Blood at the Point-of-care as a Tool to Enhance Clinical Management

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05144776
• Other study ID #: VHCRP 2103
• Status: Recruiting
• Start date: November 17, 2022
• Est. completion date: December 1, 2025

Study information

• Verified date: March 2024
• Source: Kirby Institute
• Contact: Elise Tu
• Phone: +61 2 9385 0886
• Email: etu[@]kirby.unsw.edu.au
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Nil

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

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.
• 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

Locations

Country	Name	City	State
Australia	St Vincent's Hospital Melbourne	Melbourne	Victoria
Australia	Blacktown Hospital	Sydney	New South Wales
Australia	Liverpool Hospital	Sydney	New South Wales
Australia	Prince of Wales Hospital	Sydney	New South Wales
Australia	St Vincent's Hospital	Sydney	New South Wales
Australia	STORR Liver Centre Westmead Hospital	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Kirby Institute

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluate diagnostic performance of the novel tests by hepatitis B e-antigen status	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
Secondary	Evaluate diagnostic performance of the novel tests by HBV treatment status	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
Secondary	Evaluate diagnostic performance of the novel tests by HBV DNA levels	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