乙型肝炎病毒核酸（HBV-DNA）检测程序的方法学性能评价

摘 要：目的 对本实验室乙型肝炎病毒核酸(HBV DNA)定量检测程序方法学性能进行评价，以了解其方法学性能是否符合临床及本实验室检测要求。方法 分别取高浓度(HP)和低浓度(LP)两个水平的患者标本对精密度进行评价，取国家标准品（L1-L6）对正确度、线性范围及检测下限进行评价。结果 高浓度(HP)和低浓度(LP)两个水平的患者标本CV均低于5.0%，精密度符合要求；L1-L6检测结果均在国家标准品的允许范围内，正确度符合要求；a=0.9867，r2=0.9985，线性范围符合要求；国家标准品中的L4稀释后，300 IU/mL、500 IU/mL均可检出，符合试剂盒的检测灵敏度要求。结论 本室所评价的试剂盒方法学性能指标均符合要求，适合在本室开展。

Methodological evaluation on the performance of the detection procedure of HBV DNA

Abstract: Objective To evaluate the methodological performance of the procedure for the detection of hepatitis B virus nucleic acid (HBV DNA) by real-time fluorescence quantitative polymerase chain reaction, and learn whether the methodological performance is in accordance with the clinical and the laboratory''s requirements. Methods High concentration and low concentration of patient specimens were used to evaluate the precision. The national standard samples (6 samples numbered from L1 to L6) were used to evaluate the accuracy, linear range and detection limit. Results The coefficients of variation (CV) of both high and low concentration of the specimens were lower than 5%, and the precision met the requirements. The results of the six standard samples were within the acceptable range of the national standard, and the accuracy met the requirements. The linear range met the requirements, with a=0.9867 and r2=0.9985. The diluted standard sample L4 were detected at both 300 IU/mL and 500 IU/mL, which met the requirements for the detection sensitivity of kits. Conclusion The indexes of methodological performance of the kits were evaluated as meeting the requirements.