Abstract：Objective To verify performance and evaluation of fluorescent quantitative detection method for hepatitis B virus deoxyribonucleic acid(HBV DNA).Methods According to the requirements of Application of accreditation criteria for quality and competence of medical laboratories in molecular diagnosis(CNAS-CL36)and EP series documents by the Clinical and Laboratory Standards Institute(CLSI),the precision,measurement accuracy,anti-interference ability,linear range and limit of detection of HBV DNA fluorescence quantitative PCR detection system were verified and evaluated.Results The intra assay CV of low(1×103 U/mL)and high(1×106 U/mL)value specimens were 0.07% and 0.06%,respectively,while the inter assay CV were 0.11% and 0.08%,respectively.Its accuracy was within acceptable range.The samples containing triglyceride,bilirubin,hemoglobin were detected,and the deviation between the measured value and the expected value was ≤±lg0.4.It exhibited a benign linear relation from 1.45×102-1.45×109 U/mL(Y=1.042X-0.337，R2=0.997),and the limit of detection was 100 U/mL.Conclusion The performance indexes of the fluorescent quantitative detection method of HBV DNA are consistent with the manufacturer′s statement,which can be used for routine clinical detection.
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