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

Beijing Municipal Administration of Hospitals1 个研究点分布在 1 个国家目标入组 200 人开始时间: 2026年8月1日最近更新: 2026年7月7日

适应症

干预措施

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 200
试验地点: 1
主要终点: quantitative consistency

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

The study aims to include a total sample size of approximately 200 cases: 100 positive cases: ≥ 1000 IU/mL: 40 cases; 100 - 1000 IU/mL: 30 cases; 20 - 100 IU/mL: 30 cases; 100 negative cases: lower than 20 IU/mL: 40 cases, and undetected: 60 cases. Collect the age, gender, duration of HBV infection, antiviral treatment drugs and treatment courses, HBeAg status, HBsAg quantification (if available), ALT/AST levels, date of blood sample collection, date and result of combas HBV DNA detection, and digital PCR detection results of the enrolled patients. By comparing the detection results of the two methods, evaluate the quantitative accuracy or qualitative detection ability of the digital PCR hepatitis B detection method.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Other

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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.

排除标准

•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).

研究组 & 干预措施

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.