An observational study in Hepatitis B, sponsored by Kirby Institute. Withdrawn at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-03.
Sponsored by Kirby Institute · Observational
Evaluation of novel point of care Hepatitis B diagnostic assays.
This study aims to evaluate the sensitivity of the following novel assays for evaluation of HBV infection and assessment of treatment eligibility;
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
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Participants will be enrolled into the study in two parts until the following sample sizes are met for the prospective samples Part A: At least 30 paired specimens of venous EDTA whole blood and DBS in treatment naive adults (HBV DNA detectable) Part B: At least 30 paired specimens of venous EDTA whole blood and DBS in HBV DNA undetectable adults on antiviral therapy
Exclusion Criteria:
Not currently on antiviral therapy for HBV and HBV DNA detectable
Diagnostic Test: Xpert® HBV DNA fingerstick point of care assay · Diagnostic Test: Point of Care ALT · Diagnostic Test: Xpert® HBV DNA point of care assay from dried blood spot
Stable on HBV antiviral therapy for at least 3 months with HBV DNA \< 20 IU/ml
Diagnostic Test: Xpert® HBV DNA fingerstick point of care assay · Diagnostic Test: Point of Care ALT · Diagnostic Test: Xpert® HBV DNA point of care assay from dried blood spot
Xpert® HBV DNA point of care assay from finger-stick whole blood
Point of Care ALT from finger-stick whole blood
Xpert® HBV DNA point of care assay from dried blood spot
Sensitivity and specificity of the Xpert® HBV DNA fingerstick point of care assay
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.
Time frame: Through study completion, an average of 1 year
Sensitivity and specificity of the point of care ALT
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.
Time frame: Through study completion, an average of 1 year
Sensitivity and specificity of the Xpert® HBV DNA point of care assay on dried blood spots
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.
Time frame: Through study completion, an average of 1 year
Plan to share: No
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This study is withdrawn, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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