RESUMO
Objective Use real-time fluorescence quantitative polymerase chain reaction(PCR)to determine HBV DNA,then calculate the linear range and the minimum detection limit,which are the main performance indicators in the laboratory verification. Methods According to the related documents,by serial dilution of high concentration samples,samples of serial concentrations were obtained which were out of the linear range mentioned in the instructions,then verifid the new linear range.By serial dilution of low concentration,samples were obtained,the concentrations of which were lower than the minimum detection limit of provide by the manufacturer,then the new minimum detection limit was verified.Results The linear range of HBV DNA detection was 8.58× 102 -8.41×107 IU/mL,and the minimum detection limit of HBV DNA detection was 4.07 ×102 IU/mL.Conclusion The linear range and the minimum detection limit of Real-time fluorescence quantitative PCR assessed reaches the expected requirement,and the method and validation scheme are simple and feasible.