Evaluation of Novel Point of Care Hepatitis B Diagnostic Assays

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04289428

Enrollment

Registered

2020-02-28

Start date

2022-01-31

Completion date

2022-10-31

Last updated

2021-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B

Keywords

Hepatitis B, Diagnostics, HBV DNA, ALT, Point of care, Dried blood spot

Brief summary

Evaluation of novel point of care Hepatitis B diagnostic assays.

Detailed description

This study aims to evaluate the sensitivity of the following novel assays for evaluation of HBV infection and assessment of treatment eligibility; * GeneXpert HBV DNA via Fingerstick testing, * Dried Blood Spot based HBV DNA * Point of care ALT.

Interventions

DIAGNOSTIC_TESTXpert® HBV DNA fingerstick point of care assay

Xpert® HBV DNA point of care assay from finger-stick whole blood

DIAGNOSTIC_TESTPoint of Care ALT

Point of Care ALT from finger-stick whole blood

DIAGNOSTIC_TESTXpert® HBV DNA point of care assay from dried blood spot

Xpert® HBV DNA point of care assay from dried blood spot

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Have voluntarily signed the informed consent form. 2. 18 years of age or older. 3. HBsAg positive 4. Part A: Not currently on antiviral therapy for HBV and HBV DNA detectable OR Part B: Stable on HBV antiviral therapy for at least 3 months with HBV DNA \< 20 IU/ml

Exclusion criteria

1\) Inability or unwillingness to provide informed consent or abide by the requirements of the study.

Design outcomes

Primary

Measure	Time frame	Description
Sensitivity and specificity of the Xpert® HBV DNA fingerstick point of care assay	Through study completion, an average of 1 year	To evaluate the sensitivity and specificity of the Xpert® HBV DNA point of care assay from finger-stick whole blood samples compared to plasma samples collected via venipuncture and tested on the Roche COBAS AmpliPrep/COBAS TaqMan HBV (CAP/CTM HBV) V2 assay.

Secondary

Measure	Time frame	Description
Sensitivity and specificity of the point of care ALT	Through study completion, an average of 1 year	To evaluate the sensitivity and specificity of the point of care ALT assay from finger-stick whole blood samples compared to standard of care ALT collected via venepuncture.
Sensitivity and specificity of the Xpert® HBV DNA point of care assay on dried blood spots	Through study completion, an average of 1 year	To evaluate the sensitivity and specificity of the Xpert® HBV DNA point of care assay from dried blood spot samples compared to plasma samples collected via venipuncture and tested on the Roche COBAS AmpliPrep/COBAS TaqMan HBV (CAP/CTM HBV) V2 assay.

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026