Health Condition 1: B189- Chronic viral hepatitis, unspecified
Conditions
Interventions
Intervention1: HBcrAg biomarker quantitation.: HBcrAg protein quantification using Chemiluminescence enzyme immunoassay. Duration of the intervention-6 months.
Control Intervention1: HBV DNA RT PCR as
Sponsors
Agappe Diagnostics Limited
Eligibility
Inclusion criteria
Inclusion criteria: Study group (n=250): Adult population (Above 18 years) diagnosed with CHB (HBsAg and /or HBV DNA positive for more than 6 months or histopathologically confirmed chronic hepatitis with HBsAg positive), both treatment naïve and experienced in different groups in which adequate specimen volume (minimum 1 ml) could be retrieved. Control group (n=50): True negative which is defined as virologically confirmed Hepatitis B negative cases (HBsAg negative and or anti-HBcore total negative and or HBV DNA negative), adult population (above 18 years) in which adequate specimen volume (minimum 1 ml) could be retrieved.
Exclusion criteria
Exclusion criteria: Co-infection with other hepatotropic virus (Hepatitis A/C/D/E) Cases with underlying other chronic liver disease Co-infection with HIV Patients on other immunosuppressive therapy Pregnant females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy confirmation of HBcrAg biomarker in comparison to HBV DNA real time PCR.Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: | — |
Countries
India
Contacts
Public ContactDr Ekta Gupta
Institute of Liver and Biliary Sciences
Outcome results
None listed