【摘要】 目的 验证和评价雅培ARCHITECT-i2000SR化学发光分析仪检测乙肝表面抗原(HBsAg)、抗人类免疫缺陷病毒(HIV)、抗梅毒螺旋体(TP)、抗丙型肝炎病毒(HCV)抗体的性能。方法 对ARCHITECT-i2000SR的精密度、污染携带、参考区间、分析测量范围进行验证;化学发光微粒免疫分析(CMIA)和ELISA法检测相同标本,进行方法学比对。结果HBsAg,HIV,TP,HCV抗体的精密度、携带污染和HBsAg参考区间均符合ARCH-ITECT-i2000SR的性能标准;HBsAg线性回归:Y=1.102X-6.678 6(r=0.995 5,P<0.05),HBsAg线性范围为:1.08~208.6 IU/ml;两种方法检测输血前四项结果的一致性为优。结论 ARCHITECT-i2000SR检测输血前四项的主要性能验证结果与厂家声明的范围基本一致,可用于临床样本的检测。更多还原

【Abstract】 Objective To evaluate the analytical performance of ARCHITECT-i2000 SR chemiluminescence analyzer in detection of HBsAg,HIV-antibody,TP-antibody and HCV-antibody.Methods Validated the precision,carryover,ference interval of alpha-fetoprotein and linearity performance of ARCHITECT-i2000 SR.The same specimens were tested by both CMIA and ELISA,and the results were compared and analyzed.Results The precision,carryover and ference interval of alpha-fetoprotein of HBsAg,HIV-antibody,TP-antibody and HCV-antibody were within the range provided by the manufacturer for ARCHITECT-i2000 SR.The theoretical and measured values of HBsAg were:Y = 1.102X- 6.678 6(r=0.995 5,P<0.05),the range of linearity 1.08 ~ 208.6.The sesult was very good for the four blood index by both methods.Conclusion The basic performances of ARCHITECT-i2000 SR were consistent with the data provided by the manufacturer,so it canbe used to inspect the clinical samples and the sasults were credible.更多还原