A Study on the Consistency Evaluation of Digital PCR Technology for Quantitative Detection of HBV Nucleic Acid

NCT07684209 | Not Yet Recruiting

• 1 other identifier: DTEC-KY2026-075-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The research plan aims to evaluate the consistency of the digital PCR-based hepatitis B virus nucleic acid quantification technique with the existing Roche qPCR-based detection method. Approximately 200 samples of residual serum from patients with chronic hepatitis B, covering high, medium, low, and those below the Roche lower limit concentration or undetectable, will be collected. The two methods will be used for parallel testing. The main objective is to evaluate the quantitative consistency of the two methods within the quantifiable range of Roche (≥ 20 IU/mL); the secondary objectives include evaluating the qualitative detection rate of samples with concentrations below 20 IU/mL or undetectable nucleic acid.

Conditions

Chronic Hepatitis b

Keywords

Digital PCR; Chronic Hepatitis b; Combas TaqMan HBV DNA Test

Outcome Measures

Primary Outcomes (1)

• quantitative consistency

  Evaluate the quantitative consistency of the self-developed digital PCR (ddPCR) method with the Roche Cobas TaqMan HBV DNA test (cobas HBV) within the quantifiable range (≥ 20 IU/mL)

  "Baseline, single cross-sectional testing at sample collection, through study completion"

Study Arms (5)

High-concentration group

After detection using digital PCR technology, the results were classified according to concentration levels as follows: high concentration group (≥ 1000 IU/mL); medium concentration group (100 - 1000 IU/mL); low concentration group (20 - 100 IU/mL); extremely low concentration group (below 20 IU/mL); undetectable group.

Other: the results were classified according to concentration levels

medium concentration group

After detection using digital PCR technology, the results were classified according to concentration levels as follows: high concentration group (≥ 1000 IU/mL); medium concentration group (100 - 1000 IU/mL); low concentration group (20 - 100 IU/mL); extremely low concentration group (below 20 IU/mL); undetectable group.

Other: the results were classified according to concentration levels

low concentration group

After detection using digital PCR technology, the results were classified according to concentration levels as follows: high concentration group (≥ 1000 IU/mL); medium concentration group (100 - 1000 IU/mL); low concentration group (20 - 100 IU/mL); extremely low concentration group (below 20 IU/mL); undetectable group.

Other: the results were classified according to concentration levels

extremely low concentration group

After detection using digital PCR technology, the results were classified according to concentration levels as follows: high concentration group (≥ 1000 IU/mL); medium concentration group (100 - 1000 IU/mL); low concentration group (20 - 100 IU/mL); extremely low concentration group (below 20 IU/mL); undetectable group.

Other: the results were classified according to concentration levels

undetectable group

After detection using digital PCR technology, the results were classified according to concentration levels as follows: high concentration group (≥ 1000 IU/mL); medium concentration group (100 - 1000 IU/mL); low concentration group (20 - 100 IU/mL); extremely low concentration group (below 20 IU/mL); undetectable group.

Other: the results were classified according to concentration levels

Interventions

the results were classified according to concentration levels OTHER

the results were classified according to concentration levels

High-concentration group; extremely low concentration group; low concentration group; medium concentration group; undetectable group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The research samples were derived from the routine diagnostic leftover serum samples of chronic hepatitis B patients who were treated at the outpatient or inpatient departments of Beijing Ditan Hospital, Capital Medical University. All the samples were the leftover samples obtained after the routine HBV DNA testing (combas HBV) was completed, and they were the secondary utilization of the leftover samples from clinical routine tests.

You may qualify if:

• Patients who have been diagnosed with chronic hepatitis B (in accordance with the diagnostic criteria of the "Chronic Hepatitis B Prevention and Treatment Guidelines (2022 Edition)") and are currently receiving NAs antiviral treatment for ≥ 6 months or have not received treatment and are ≥ 18 years old;
• Remaining samples (serum) that have undergone combas HBV DNA testing and have clear test results, with the sample collection time frozen for ≤ 6 months;
• The remaining sample volume is sufficient (≥ 1.0 mL), sufficient for digital PCR testing and necessary duplicate testing;
• Samples from the same patient at different time points can be included as independent samples, but the sampling interval time needs to be recorded.

You may not qualify if:

• Combine other liver virus infections such as HCV, HDV or HIV;
• Poor sample quality, such as severe hemolysis, lipemia or repeated freezing and thawing ≥ 3 times;
• The samples were not properly frozen and stored (-80℃) after collection or the temperature records were missing;
• The clinical information is severely lacking, making it impossible to confirm the diagnosis and treatment status;
• The duplicate samples already included at the same time point (only the first included sample is retained).

Sponsors & Collaborators

• Beijing Municipal Administration of Hospitals: lead

Study Sites (1)

Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100015, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

The research samples were derived from the routine diagnostic leftover serum samples of chronic hepatitis B patients who were treated at the outpatient or inpatient departments of Beijing Ditan Hospital, Capital Medical University. All the samples were the leftover samples obtained after the routine HBV DNA testing (combas HBV) was completed, and they were the secondary utilization of the leftover samples from clinical routine tests.

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: July 7, 2026

Record last verified: 2026-07

Locations

CN (1)