自制HBV DNA质控血清的临床应用与评估

Clinical application and evaluation of self-made HBV DNA quality control serum

目的:探讨自制质控血清用于HBV DNA定量检测室内质量控制的可行性。方法:收集正常血清和HBV DNA高水平的异常血清,充分混匀配成HBV DNA质控血清,该血清灭活后分装并置于-20℃保存,每支质控血清室温融化半小时后与患者标本在相同条件下进行检测,剩余血清置于4℃保存,并在2周内用完。结果:质控血清的管间差为1.23%,12个月测定的月均值差异无统计学意义(F=1.48,P=0.14),而且质控血清开盖后于4℃密封保存2周,其测定结果差异无统计学意义(4.83±0.20VS4.83±0.23,P=0.91)。结合"Lev-ery-Jennings"质控规则能有效地识别包括标本降解、扩增效率异常或者标准品降解引起的失控。结论:自制HBV DNA质控血清均一稳定,-20℃至少可稳定保存1年,4℃至少可稳定保存2周,能满足室内质量控制的要求。

Objective： To investigate feasibility of the self-made quality control serum as an internal quality control for quantitating HBV DNA. Method： Normal serum and abnormally high levels HBV DNA serum were collected and mixed thoroughly to make HBV DNA quality control serum, then the serum were disinfected and transferred into EP tubes. All the control serum were kept at -20℃ until analyzed. Every one tube of control ser urn was thawed at room temperature for half hour, then treated and detected like daily clinical samples. The remai- ning serum were stored at 4℃ and detected within two weeks. Result： The tube-to tube variation was 1.23%. There was no significant difference among 12 monthly means of control serum（F 1.48, P 0. 14）. If the recapped control serum was used and stored at 4℃ for two weeks, no significant difference in measurement results was found（4.83±0.20 VS 4.83±0.23, P ：0.91）. In addition, combining with Levery-Jennings control rules, the self-made control serum could discriminate the events out of control resulted from sample degradation, stand- ard degradation and abnormal amplification efficiency. Conclusion： The selLmade HBV DNA control serum was homogeneous and stable, which was stable for 1 year and two weeks at least at -20℃ and 4℃, respectively, therefore, the self-made serum conformed to the requirement as an internal quality control.