Prevalence of Occult HBV Infection Among Anti-HBc Alone Group in Northern Taiwan

Atni-HBs to HBsAg and Anit-HBc was interpreted based on three hepatitis markers for clinical detection of HBV-infections. HBAg and Anti-HBs were negative and the Anit-HBc-positive referred to as Anti-HBc alone. When the Anti-HBc alone occurs, patients may be due to mutations in HBV HBsAg can not be detected due to (1), but if by the molecular diagnostics by polymerase chain reaction (PCR) technology can detect HBV DNA present. When Anti-HBc alone in patients with serum HBV DNA can be measured, then there may be occult HBV infection. In different countries, Occult HBV infection in the Anti-HBc Alone group had significant differences in the prevalence (2.9 ~ 22.8%) (2), but prevalence survey in Taiwan there are very few studies on this , It is hoped to be able to investigation the prevalence of occult HBV infection Among Anti-HBc Alone.

Study Overview

• Status: Unknown
• Conditions: HBV Coinfection

Detailed Description

The main use of this program, Taipei Medical University - Wan Fang Hospital in clinical specimens using the Roche system (Corbas e601) operating HBsAg, Anti-HBs, Anti-HBc to screen for the Anti-HBc alone group. Recycling Roche molecular system (Taq48) Real-time PCR to detect all anti-HBc alone population to understand their serum HBV-DNA viral load, in order to understand Occult HBV infection in the Anti-HBc alone group, the prevalence and viral load changes in these studies through the clinical units to provide occult HBV infection as a reference basis.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Taipei Medical University - WanFang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

anti-HBc alone（HBsAg(-)；Anti-HBs(-)；Anti-HBc(+)）；occult HBV infection（the presence of HBV DNA in the liver and blood, in the absence Occult HBV of detectable HBsAg

Description

Inclusion Criteria:

HBsAg(-)；Anti-HBs(-)；Anti-HBc(+)

Exclusion Criteria:

None

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Taipei Medical University WanFang Hospital
• Investigators: Study Director: Yi-Kue Chen, college, Taipei Medical University WanFang Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Study Completion (Anticipated): May 1, 2012

Study Registration Dates

• First Submitted: July 4, 2011
• First Submitted That Met QC Criteria: July 14, 2011
• First Posted (Estimate): July 18, 2011

Study Record Updates

• Last Update Posted (Estimate): October 12, 2011
• Last Update Submitted That Met QC Criteria: October 11, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: anti-HBc alone ；occult HBV infection
• Additional Relevant MeSH Terms: Infections; Coinfection
• Other Study ID Numbers: 100028