Sysmex HISCL5000化学发光分析仪检测乙型肝炎标志物性能评价

Performance evaluation of Sysmex HISCL5000 in detecting HBV markers

目的评价Sysmex HISCL5000化学发光免疫分析仪(以下简称HISCL5000分析仪)对乙型肝炎血清标志物检测的分析性能。方法用HISCL5000分析仪进行HBsAg、HBsAb、HBeAg、HBeAb、HBcAb检测,根据美国临床和实验室标准化协会(CLSI)颁布的EP系列文件对仪器分析性能进行评价。结果 HISCL5000分析仪检测HBsAg、HBsAb、HBeAg、HBeAb、HBcAb低浓度和高浓度两个浓度批内不精密度变异系数(CV)%分别为1.24%、1.05%、2.56%、2.27%、2.19%、1.95%、2.37%、1.43%、2.49%、1.29%;总不精密度CV%分别为2.32%、1.74%、3.12%、2.45%、2.94%、2.96%、3.02%、1.82%、3.21%、1.54%。HBsAg检测线性r^2=0.976 5,HBsAb检测线性r^2=0.951 6,两者r^2均大于0.95。HISCL5000分析仪和e601分析仪HBsAg检测结果比对:r^2=0.982 2,HBsAb检测结果比对:r^2=0.974 8。HISCL5000分析仪与ELISA两种方法检测HBsAg、HBsAb、HBeAg、HBeAb、HBcAb结果的符合率分别为99.6%(550/552)、93.5%(516/552)、99.6%(550/552)、94.9%(524/550)、92.0%(508/552)。HISCL5000分析仪检测HBsAg携带污染X=0.070 8,3SD(L-L)=0.106 2,X<3SD(L-L)。HISCL5000分析仪检测HBsAg、HBsAb下限分别为0.006IU/mL、0.213 6mIU/mL。结论 HISCL5000分析仪检测乙型肝炎血清标志物的精密度、线性范围、比对结果、携带污染、检测下限均达到要求,能满足临床需求。

Objective To analyze performance of Sysmex HISCL5000 chemical luminescence immunity analyzer in detecting HBV markers.Methods Evaluate the accuracy,linearity,carry pollution,the comparison results and detection limit of HISCL5000 according to Clinical and Laboratory Standards Institute（CLSI）documents.Results Inter-inaccuracy of HISCL5000 in detecting HBsAg,HBsAb,HBeAg,HBeAb and HBcAb with low and high concentrations were 1.24%,1.05%,2.56%,2.27%,2.19%,1.95%,2.37%,1.43%,2.49%,1.29% respectively;Total-inaccuracy were 2.32%,1.74%,3.12%,2.45%,2.94%,2.96%,3.02%,1.82%,3.21%,1.54% respectively.The linearity of HBsAg and HBsAb were 0.976 5and 0.951 6,the both greater than0.95.The comparison result of HISCL5000 and e601in HBsAg and HBsAb were 0.982 2and 0.974 8.Coincidence of HISCL5000 and ELISA in HBsAg,HBsAb,HBeAg,HBeAb,HBcAb were 99.6%（550/552）,93.5%（516/552）,99.6%（550/552）,94.9%（524/550）,92.0%（508/552）respectively.The carry pollution of HISCL5000 when detecting HBsAg was X =0.070 8,3SD（L-L）=0.106 2,X3SD（L-L）.Meanwhile detection limit in HBsAg and HBsAb were 0.006IU/mL,0.213 6mIU/mL.Conclusion HISCL5000 is suitable for clinical application with good precision,accuracy,linearity,carry pollution,the comparison results and detection limit.