HIV抗原及抗体联合定量测定的分析性能验证与评价  

Validation and Evaluation of Analytical Performance of Combined Quantitative Assay of HIV Antigen and Antibody

作　　者：曾庆洋 曾令恒 ZENG Qing-yang;ZENG Ling-heng(Department of Medical Laboratory,Nanhai Hospital of Southern Medical University,Foshan 528244 China)

机构地区：[1]南方医科大学南海医院医学检验科,广东佛山528244

出　　处：《内蒙古医学杂志》2020年第5期513-516,共4页Inner Mongolia Medical Journal

基　　金：广东省医学科研基金(编号:A2016628);佛山市十三五医学重点专科和特色专科建设基金项目(编号:FSZDZK135045);佛山市南海区“十三五”医学重点专科基金项目(编号:2016-2020);佛山市医学骨干人才选拔培养项目(编号:2019-2021)。

摘　　要：目的验证与评价ARCHITECT I2000全自动化学发光免疫分析仪对HIV抗原及抗体联合定量测定的分析性能。方法参照美国临床实验室标准化协会(CLSI)系列文件,对HIV检测的精密度、准确度、CUTOFF值和携带污染率进行验证。结果 HIV测定的批内精密度变异系数(CV)为4.9%~7.4%和批间精密度(CV)为6.2%~9.9%,均符合厂家声明要求。HIV测定的敏感性为100%,特异性为100%,符合率为100%。阴性标本S/CO(x±3SD)为0.021~0.104,均小于CUTOFF值(1.0)。携带污染率为0.001%。结论 ARCHITECT I2000全自动化学发光免疫分析仪对HIV抗原及抗体联合定量测定的主要分析性能符合临床要求,检测结果准确可靠,可用于临床样本的初筛检测。Objective To validate and evaluate the analytical performance of ARCHITECT I2000 automatic chemiluminescence immunoassay for the combined quantitative determination of HIV antigen and antibody.Methods Referring to CLSI series of documents,the accuracy, CUTOFF value and contamination rate of HIV detection were verified. Results The coefficient of variation(CV) of intra assay precision(4.9%~7.4%) and inter assay precision(CV)of HIV were 6.2%~9.9%,all of which met the manufacturer’s declaration requirements. The sensitivity, specificity and coincidence rate of HIV test were 100%, 100% and 100%, respectively. The S/CO(x+3 SD) of negative specimens was 0.021~0.104, which was lower than CUTOFF(1.0).The contamination rate was 0.001%.Conclusion The main analytical performance of ARCHITECT I2000 automatic chemiluminescence immunoassay instrument for the combined quantitative determination of HIV antigen and antibody meets the clinical requirements, and the results are accurate and reliable, which can be used for the preliminary screening of clinical samples.

关 键 词：性能评价 化学发光法 HIV 

分 类 号：R392[医药卫生—免疫学] R446.6[医药卫生—基础医学]