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

Inclusion Criteria:

1. 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;
2. Remaining samples (serum) that have undergone combas HBV DNA testing and have clear test results, with the sample collection time frozen for ≤ 6 months;
3. The remaining sample volume is sufficient (≥ 1.0 mL), sufficient for digital PCR testing and necessary duplicate testing;
4. Samples from the same patient at different time points can be included as independent samples, but the sampling interval time needs to be recorded.

Exclusion Criteria:

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