【摘要】 目的对国产PCR扩增仪、国产试剂实时荧光定量PCR检测HBV-DNA的性能作验证评价。方法以两质控血清按《医院检验科建设管理规范》方案作批内、批间不精密度评价;以定值标准血清重复3次测量,以偏差作准确性评价;以定值质控血清10倍倍比稀释,所得各样本重复3次测定,以示值与测定平均值作相关分析,作为线性评价;以定值标准血清样本,10次重复检测,以均能检测出阳性值(非阴性)为标准,评价最低检测限。结果两质控血清批内、批间精密度均<5%;定值标准血清测量值对数值与认定值偏差不超过±0.5;线性评价相关性r=0.990,P<0.000;最低检测限符合试剂盒说明。结论本实验室HBV-DNA荧光定量PCR检测系统性能符合YY/T 1182—2010《核酸扩增检测用试剂(盒)》要求,符合所用试剂盒说明的要求。更多还原

【Abstract】 Objective To verify the performance evaluation of detecting HBV- DNA with domestic PCR amplification and domestic reagent by real- time fluorescence quantitative PCR. Methods Two quality control serum were evaluated imprecisely within and between groups according to the program of Specification for Construction and Management of Hospital Laboratory; the fixed value standard serums were determined for 3 times and the standard deviations were used for accuracy evaluation; the fixed value standard serum was diluted to 10 times,each sample was determined for 3 times,and the linear correlation between the determination values and the average values was analyzed. The fixed standard serum samples were determined for 10 times,the detected positive values( non negative) were used as the standard, and the minimum detection limit was evaluated.Results The precisions of the two quality control serums between intra and inter batch were bellow 5%; the deviations between the measurement numerical values of the fixed standard serums and the certified values value were within the range of < 0. 5; the linearity correlation was r = 0. 990,P < 0. 000; the lowest detection limit met the requirement of kit. Conclusion The performance of HBV- DNA fluorescence quantitative PCR detection system conforms to the requirement of YY / T 1182—2010 Nucleic Acid Amplification Detection Reagent( Box) and that of the kit.更多还原