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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,300IU/mL、500IU/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。
OBJECTIVE To evaluate the methodological performance of HBV-DNA quantitative assay in our laboratory to find out whether its methodological properties are in accordance with clinical and laboratory testing requirements. Methods The precision of patients with high and low concentration (LP) were evaluated respectively. The accuracy, linearity range and detection limit of national standards (L1-L6) were evaluated. Results The CVs of patients with both HP and LP were lower than 5.0% and the precision was satisfactory. The results of L1-L6 were within the allowable range of national standard, and the accuracy was satisfactory. a = 0.9867, r2 = 0.9985, linear range to meet the requirements; L4 national standard dilution, 300IU / mL, 500IU / mL can be detected, in line with the detection sensitivity of the kit requirements. Conclusion The methodological properties of the kits evaluated in this study are in line with the requirements and are suitable to be carried out in our laboratory.