Abstract:

Objective 　To investigate the uncertainty of hepatitis B virus (HBV) DNA determination by fluorescence quantitative polymerase chain reaction (PCR) according to quality control data,and evaluate the feasibility. Methods　The uncertainty of Type A was evaluated by the data of within-run and between-run coefficients of variation. The uncertainty of Type B was evaluated according to the data of external quality assessments from the National Center for Clinical Laboratory and College of American Pathologists(CAP). The combined uncertainties and expanded uncertainties were evaluated and analyzed. Results　The expanded uncertainties in 10⁴-10⁵ IU/mL and 10⁶-10⁷ IU/mL concentrations were 0.521 6 and 0.529 8(k=1.96,n=1),according to the data from the National Center for Clinical Laboratory. The expanded uncertainties in 10⁴-10⁵ IU/mL and 10⁶-10⁷ IU/mL concentrations were 0.973 1 and 0.977 5(k=1.96,n=1),according to the data from CAP. Conclusions　It is not bilievable to evaluate the uncertainty of HBV DNA determination by fluorescence quantitative PCR,and it is suitable to evaluate the uncertainty using the results traced back to the national standard substance.

Key words: Uncertainty, Polymerase chain reaction, Hepatitis B