Performance validation of hepatitis B virus DNA quantification by AUTRAX automatic nucleic acid extraction workstation / 国际检验医学杂志

ABSTRACT

Objective To verify the performance of a novel HBV DNA assay based on AUTRAX automatic nucleic acid extrac-tion workstation .Methods According to the evaluation protocols of Clinical and Laboratory Standards Institute (CLSI) ,the per-formance of a novel HBV DNA assay was assessed in the aspects of accuracy ,precision ,lower limit detection ,linearity ,interference rejection and pollution prevention .Results The accuracy rate of this assay for laboratory evaluation samples of Shanghai Clinical Laboratory Center was 100% during 2015 to 2016 ,with each deviation between observed and expected values within ± 0 .18 lg IU/mL .The intra-assay and inter -assay CV of two levels (106 ,104 ) samples were both less than 5% .Detectable rates of lower limit of detection (LOD) and lower limit of quantitation (LOQ) were 5/5 at 20IU/mL and 40 IU/mL ,respectively .And intra-assay CV of LOQ was 3 .18% ,less than 5% .Linearity assessment exhibited an excellent dynamic range of linear quantification from 40 to 108 IU/mL(Y=1 .0182X-0 .3182 ,R2 =0 .978) .According to product manual ,conjugated bilirubin ,hemoglobin and triglyceride as interfering substance were made at concentration of 600 μmol/L ,7 g/L and 4 .5 mmol/L ,separately ,which had no interference for two levels (106 ,104 ) samples .Each deviation value between interference group and control group was within ± 0 .45 lg IU/mL .No pollution phenomenon was found .Conclusion The novel HBV DNA quantification by AUTRAX automatic nucleic acid extraction workstation has excellent performance in aspects of accuracy ,precision ,lower limit detection ,linearity ,interference rejection and pollution prevention ,which can be used for the detection of clinical specimens .