CAJ | 학술논문

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 ARCHITECT-i2000SR 的性能标准；HB-sAg 线性回归：Y ＝1.102X －6.6786（r＝0.9955，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。
목적：험증화평개아배 ARCHITECT-i2000SR 화학발광분석의검측을간표면항원（HBsAg）、항인류면역결함병독（HIV）、항매독라선체（TP）、항병형간염병독（HCV）항체적성능。방법대 ARCHITECT-i2000SR 적정밀도、오염휴대、삼고구간、분석측량범위진행험증；화학발광미립면역분석（CMIA）화 ELISA 법검측상동표본，진행방법학비대。결과HBsAg，HIV，TP，HCV 항체적정밀도、휴대오염화 HBsAg 삼고구간균부합 ARCHITECT-i2000SR 적성능표준；HB-sAg 선성회귀：Y ＝1.102X －6.6786（r＝0.9955，P ＜0.05），HBsAg 선성범위위：1.08～208.6 IU／ml；량충방법검측수혈전사항결과적일치성위우。결론ARCHITECT-i2000SR 검측수혈전사항적주요성능험증결과여엄가성명적범위기본일치，가용우림상양본적검측。
Objective To evaluate the analytical performance of ARCHITECT-i2000SR chemiluminescence analyzer in detec-tion of HBsAg,HIV-antibody,TP-antibody and HCV-antibody.Methods Validated the precision,carryover,ference interval of alpha-fetoprotein and linearity performance of ARCHITECT-i2000SR.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-feto-protein of HBsAg,HIV-antibody,TP-antibody and HCV-antibody were within the range provided by the manufacturer for ARCHITECT-i2000SR.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-i2000SR were consistent with the data provided by the manufacturer,so it canbe used to inspect the clinical samples and the sasults were credible.