Prevalence and Burden of Hepatitis D Virus Infection in China Through Preoperative Examination Test (Predict Study)

Study Overview
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Brief Summary
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In China, there is no recommendation for Hepatitis D virus (HDV) screening, but the fact is estimated that one-third of the world's population of individuals with chronic Hepatitis B virus (HBV) infection live in China while we do not know the prevalence of co-infection of HBV/HDV in China. So far, no nationwide study has been undertaken to evaluate the epidemiology of hepatitis D, on the other hand, reports of HDV infection rate in different regions of China are not consistent because of the different detection methods and detection objects. Here, we plan to test HDV-Ab/RNA for 5000 HBsAg reactive samples from 10 major tertiary hospital and to know the prevalence and disease burden of HDV in China.

Official Title
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Prevalence and Burden of Hepatitis D Virus Infection in China Through Preoperative Examination Test (Predict Study)

Conditions
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Hepatitis D, Hepatitis B, Antibodies; Anti-D, RNA Virus Infections

Intervention / Treatment
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* Diagnostic Test: HDV-Ab (IgG), HDV-RNA, RNA genotype


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Positive HBV surface antigen (HBsAg) Age 18 yeas and above Exclusion Criteria: 1. Severe cardiac, renal, respiratory, hematological, or psychiatric illness.

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: HDV-Ab (IgG), HDV-RNA, RNA genotype|Anti-HDV was evaluated semiquantitatively by means of end-point dilutions. Quantitative HDV-RNA was performed by means of LightCycler 2.0. Genotyping of HDV was performed by direct sequencing of the delta antigen region.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HDV seroprevalence and HDV RNA prevalence amongst HBsAg positive carriers in China. | Briefly, serum samples were tested undiluted, and after dilution of 1:10, 1:100, 1:1,000, 1:5,000, 1:10,000, 1:50,000, and was considered the highest dilution with a S/Co value >1.0. The detection system consisted of a competitive enzyme immunoassay, in which Anti-HDV antibodies (IgG/IgM), if present in the sample, compete with a virus-specific human polyclonal IgG, labeled with peroxidase (HRP), for a ţxed amount of full-length rec-HDV coated on the microplate. Qualitative HDV RNA was determined by in-house Polymerase Chain Reaction (PCR). Quantitative HDV-RNA was performed by means of LightCycler 2.0 (lower limit of detection 10 copies/reaction). | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The distribution of HDV genotypes in China | Genotyping of HDV was performed by direct sequencing of the delta antigen region. | 3 months |