Evaluation of Novel Point of Care Hepatitis B Diagnostic Assays

Kirby Institute

Status: Withdrawn

Conditions: Hepatitis B

Treatments: Diagnostic Test: Point of Care ALT; Diagnostic Test: Xpert® HBV DNA point of care assay from dried blood spot; Diagnostic Test: Xpert® HBV DNA fingerstick point of care assay

Study type: Observational

Funder types: Other

Identifiers

NCT04289428

VHCRP2001

Details and patient eligibility

About

Evaluation of novel point of care Hepatitis B diagnostic assays.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

0 participants in 2 patient groups

A

Description:

Not currently on antiviral therapy for HBV and HBV DNA detectable

Treatment:

Diagnostic Test: Point of Care ALT

Diagnostic Test: Xpert® HBV DNA fingerstick point of care assay

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

B

Description:

Stable on HBV antiviral therapy for at least 3 months with HBV DNA \< 20 IU/ml

Treatment:

Diagnostic Test: Point of Care ALT

Diagnostic Test: Xpert® HBV DNA fingerstick point of care assay

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