Abstract: Objective: To verify the detection performance of Tianlong HBV nucleic acid ultra-sensitive quantification kit on cobas^® Z480 automated quantitative PCR thermocycler and assess whether it meets clinical application requirements.Methods: According to CNAS-GL039 "Guidance on the Performance Verification for Molecular Diagnostic Procedures" and CNAS-CL02-A009 "Guidance on the Application of Accreditation Criteria for the Medical Laboratory Quality and Competence in the Field of Molecular Diagnostics", clinical serum samples, HBV DNA national serum standard materials and WHO international standard were used to verify the precision, accuracy, linear range, quantitative limit, detection limit, anti-interference ability, cross-contamination, reagent batch difference and nucleic acid room temperature placement time.Results: The repeatability precision of the system at 10², 10³and 10⁶IU/mL was 2.60%, 2.43%, and 0.91%, respectively, and the intermediate precision was 4.41%, 3.36%, and 2.48%, respectively. The differences between the expected and tested concentrations of the HBV DNA national standards including GBW(E) 090586(200 IU/mL), GBW(E) 090137(1.41×10³IU/mL), and GBW(E) 090139(4.60×10⁶IU/mL) were all within 0.4 Log₁₀IU/mL. The linearity range was 2.32×10¹-2.32×10⁹IU/mL, and the linear regression equation was Y=0.993 2 X+0.161 2, R²=0.998 9. The detection limit of the system was 10 IU/mL, and its limit of quantification was 30 IU/mL. When the concentration of hemoglobin(Hb) was less than 10 g/L, total bilirubin(Tb) was less than 512 μmol/L, and triglyceride(TG) was less than 18 mmol/L, there was no effect on the detection results(bias＜±7.5%). There was no cross-contamination during the“checkerboard”test. The detection differences between different batches of the kits met the requirements(bias＜±7.5%). When the nucleic acid exacted by the magnetic bead method was placed at room temperature for 2 hours, there was no effect on the detection results(bias＜±7.5%).Conclusion: The detection performance of the Tianlong HBV nucleic acid quantification kit on the cobas^® Z480 automated quantitative PCR thermocycler basically can meet clinical application requirements.