摘要
目的评价Roche电化学发光法联合检测HIV抗原抗体试剂的检测性能。方法收集包括健康献血员、人类免疫缺陷病毒(HIV)感染者、丙型肝炎病毒(HCV)抗体阳性和高危人群在内的血清样本1 327例。购买美国BBI公司的7套HIV血清转换盘共计51份血清样本。采用Roche cobas e411(架式系统)电化学全自动免疫分析仪和相应的检测试剂、校准品和质控品以及检测参数进行测定。以Roche Elecsys HIV Combi试剂盒为评估试剂,以生物梅里埃Vironostika Uni-FormⅡplus O HIV抗体试剂盒为参比试剂。定性检测血清HIV p24抗原和HIV1/2抗体并评价检测方法分析性能、结果一致性和血清转化灵敏度。结果 Roche Elecsys HIV Combi试剂盒批内和天间不精密度良好,符合临床使用要求。血清样本检测结果和参比试剂检测结果一致性完全符合。评估试剂的血清转化灵敏度比参比试剂平均提前了5.1 d。结论 Roche Elecsys HIV Combi试剂盒具有良好的精密度和血清转换灵敏度,有利于筛查HIV早期感染,能为临床HIV早期诊断、随访监测提供有效的实验室诊断依据。
Objective To evaluate the performance of Roche Elecsys HIV Combi reagent in detecting HIV p24-antigen and HIV1/2 antibody.Methods A total of 1 327 serum samples were collected for healthy subjects,patients with human immunodeficiency virus（HIV） infection and patients with antibody positive and high-risk hepatitis C virus（HCV）.The 1 327 serum samples were detected by Roche cobas e411 Elecsys HIV Combi reagent and Vironostika Uni-FormII plus O HIV reagent,respectively.The both reagents were used to detect 51 serum samples of 7 seroconversion panels from American BBI company,and the analytical performance,consistency and the sensitivity of seroconversion were evaluated.Roche Elecsys HIV Combi reagent was as evaluation reagent,and Vironostika Uni-Form II plus O HIV reagent was as reference reagent.Results The Roche Elecsys HIV Combi reagent had good within-run and interday precisions,which met the clinical requirements.The consistency of the results of the 2 reagents was good.The sensitivity of seroconversion of Roche Elecsys HIV Combi reagent was 5.1 ahead of the Vironostika Uni-Form II plus O HIV reagent.Conclusions Roche Elecsys HIV Combi reagent has a good precision and sensitivity of seroconversion,which can provide the reference for early screening,diagnosing and follow-up monitoring HIV infection.
出处
《检验医学》
CAS
北大核心
2011年第12期845-849,共5页
Laboratory Medicine
基金
国家临床重点检验专科建设项目资助
