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A Study on the Consistency Evaluation of Digital PCR Technology for Quantitative Detection of HBV Nucleic Acid
Sponsor: Beijing Municipal Administration of Hospitals
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
Conditions
Interventions
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