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NCT07684209

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

Sponsor: Beijing Municipal Administration of Hospitals

View on ClinicalTrials.gov

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.

Official title: A Study on the Consistency Evaluation of Digital PCR Technology for Quantitative Detection of Hepatitis B Virus Nucleic Acid

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2026-08-01

Completion Date

2028-08-01

Last Updated

2026-07-06

Healthy Volunteers

Not specified

Interventions

OTHER

the results were classified according to concentration levels

the results were classified according to concentration levels

Locations (1)

Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, China