Abstract: Objective To evaluate the anti-interference capability of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) quantitative reagents. Methods HBV DNA positive serum samples with critical concentrations, low, medium and high were collected. The analysis of interference was performed in four HBV DNA positive samples with hemoglobin (Hb) ranging from 1.63 to 17.25 g/L or total bilirubin (TBIL) ranging from 26.55 to 497.50 μmol/L by quantitative real-time polymerase chain reaction (q-RT-PCR). According to criterion of China National Accreditation Service for Conformity Assessment (CNAS) CL-36, if the bias is higher than and equal to ±7.5%, there will be interference with the detection of HBV DNA. Results All of the HBV DNA positive sample were subjected to interference with Hb ranging from 7.75 to 17.25g/L, and were not subjected to interference with Hb less than or equal to 3.50 g/L. For TBIL ranging from 274.60 to 399.15 μmol/L, the sample with HBV DNA viral load 2.24×10⁸ IU/mL was the only one without interference. For TBIL=153.55μmol/L, only the sample with HBV DNA viral load 4.62×10² IU/mL was subjected to interference. None of the HBV DNA positive sample were subjected to interference with TBIL less than or equal to 26.55μmol/L. Conclusion The HBV DNA quantitative reagent has certain anti-interference capability:there was no interference effect on HBV DNA results when Hb is less than or equal to 3.50 g/L and TBIL is less than or equal to 26.55 μmol/L.

Key words: hepatitis B virus, PCR, hemoglobin, total bilirubin, interference