Prevalence of Occult Hepatitis B Virus Infection?OBI? in Subjects With Chronic Hepatitis B?CHB? Family History
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Chronic Hepatitis B
- Type
- Observational
- Design
- Observational Model: Family-BasedTime Perspective: Prospective
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Both males and females
Description
Serum samples were tested for liver enzymes and liver synthesis function including ALT, aspartate aminotransferase?AST?, and albumin, etc. using a Hitachi 7600 automatic analyzer and reagent system (Hitachi, Tokyo, japan). HBsAg quantification was performed using automated electrochemiluminescence I...
Serum samples were tested for liver enzymes and liver synthesis function including ALT, aspartate aminotransferase?AST?, and albumin, etc. using a Hitachi 7600 automatic analyzer and reagent system (Hitachi, Tokyo, japan). HBsAg quantification was performed using automated electrochemiluminescence Immunoassay (ECLIA) manufactured by Roche. HBsAb, HBeAg, HBeAb and HBcAb were measured semi-quantitatively using Chemiluminescence Immunoassay (CLIA) manufactured by Abbott Diagnostics (USA). Serum HBV DNA levels were measured using the COBAS TaqMan HBV Monitor Test, with a lower limit of detection of 20 IU/mL (100 copies/mL). The false negative result excluding OBI due to Real time PCR (lower limit of 20 IU/ml) technically may exist. The study group plan to carry out nested PCR (specifically target the HBV Pre-S, S, Pre-C/Core, and X open reading frames) on subjects with HBsAg (-) HBV DNA (-) and HBcAb(+) to double check the potential false negative result in HBV DNA from Real time PCR. Quantitation of intrahepatic HBV cccDNA by quantitative real-time PCR (qPCR).
Tracking Information
- NCT #
- NCT04672915
- Collaborators
- Not Provided
- Investigators
- Study Director: Yingren Zhao First Affiliated Hospital of Xian JiaotongUniversity