Estimation and application of uncertainty of measurement in detecting of hepatitis B virus DNA by method of fluorescence quantitative polymerase chain reaction / 中华检验医学杂志

ABSTRACT

Objective To estimate the uncertainty of measurement in detecting of hepatitis B virus DNA(HBV DNA)by method of fluorescence quantitative polymerase chain reaction(FQ-PCR),and discuss the application value.Methods The process of the detection of HBV DNA by FQ-PCR was analysed to confirm and simplify the sources of uncertainties of measurement,which were obtained by disposing the data of methodology validation,internal quality control(type A evaluation of uncertainty)and external quality assessment(type B evaluation of uncertainty);combined uncertainty and expanded uncertainty were obtained by statistical methods.Results The main sources of uncertainties of measurement wereprecision within laboratory,precision between laboratory,method bias.The expanded uncertainty of HBV DNA by FQ-PCR was U=0.62(k=1.96,n=2).The uncertainty caused by method bias was found mostly.Conclusion Expanded uncertainty can be compared in different results of HBV DNA by FQ-PCR,and it provides guide significance for observing the cure effect of anti-HBV and choosing the concentration of quality control.