Evaluation of Novel Point of Care Hepatitis B Diagnostic Assays

Study Overview
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Brief Summary
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Evaluation of novel point of care Hepatitis B diagnostic assays.

Detailed Description
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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.

Official Title
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Evaluation of Novel Point of Care Hepatitis B Diagnostic Assays

Conditions
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Hepatitis B

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have voluntarily signed the informed consent form. 18 years of age or older. HBsAg positive 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>Not currently on antiviral therapy for HBV and HBV DNA detectable | Diagnostic Test: Xpert® HBV DNA fingerstick point of care assay<br>* Xpert® HBV DNA point of care assay from finger-stick whole blood<br>Diagnostic Test: Point of Care ALT<br>* Point of Care ALT from finger-stick whole blood<br>Diagnostic Test: Xpert® HBV DNA point of care assay from dried blood spot<br>* Xpert® HBV DNA point of care assay from dried blood spot<br>|
| B<br>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<br>* Xpert® HBV DNA point of care assay from finger-stick whole blood<br>Diagnostic Test: Point of Care ALT<br>* Point of Care ALT from finger-stick whole blood<br>Diagnostic Test: Xpert® HBV DNA point of care assay from dried blood spot<br>* Xpert® HBV DNA point of care assay from dried blood spot<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis B, Diagnostics, HBV DNA, ALT, Point of care, Dried blood spot