HBV DNA荧光定量检测方法的性能验证及评价

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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.

Key words： Hepatitis B virus Nucleic acid quantification Performance verification Fluorescence quantitative PCR

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	Articles by authors
	CHEN Mei-lian
	XIE Li-zhu
	MO Qi-wen
	LI Liu-yan
	XIE Ling-ping
	FANG Xiu-zhu

Cite this article:

CHEN Mei-lian,XIE Li-zhu,MO Qi-wen, et al. Performance verification and evaluation of fluorescent quantitative detection method for HBV DNA[J]. 中国当代医药, 2021, 28(22): 28-31.

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http://dangdaiyiyao.com/EN/ OR http://dangdaiyiyao.com/EN/Y2021/V28/I22/28

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