HIV抗原抗体光激化学发光法联合检测试剂的评价  

The Evaluation of Reagents for Joint Detection of HIV Antigen and Antibody by Light Initiated Chemiluminescence Assay

作　　者：宋淑静[1] 马小亮[1] 杨晓玲[1] 刘亚楠[1] 陈丽娟[1] 李娟[1] 王雅杰 SONG Shu-jing;MA Xiao-liang;YANG Xiao-ling;LIU Ya-nan;CHEN Li-juan;LI Juan;WANG Ya-jie(Department of Clinical Laboratory,Beijing Ditan Hospital,Capital Medical University,Beijing 100015,China)

机构地区：[1]首都医科大学附属北京地坛医院

出　　处：《标记免疫分析与临床》2019年第10期1758-1761,共4页Labeled Immunoassays and Clinical Medicine

基　　金：首都医科大学附属北京地坛医院院内科研基金“育苗计划”项目(编号:DTYM201803)

摘　　要：目的评价北京科美生物技术有限公司的人类免疫缺陷病毒抗原抗体(HIV Ag/Ab)检测试剂盒(光激化学发光法)与已上市HIV抗原抗体检测试剂盒的一致性以及血清转化灵敏度。方法收集363例血清样本,包括HIV患者样本、健康人员样本、以及类风湿因子样本、孕妇样本、ANA阳性样本、乙型病毒性肝炎和丙型病毒性肝炎患者等干扰样本;另外有10套HIV血清转换盘共120份血清样本。检测采用LiCA 500自动光激化学发光检测仪和相应的检测试剂、校准品和质控品以及检测参数,定性检测血清HIV1 p24抗原和HIV1/2抗体并评价与参比试剂结果一致性和血清转化灵敏度。结果北京科美生物技术有限公司的人类免疫缺陷病毒抗原抗体(HIVAg/Ab)检测试剂盒(光激化学发光法)血清样本检测结果和参比试剂检测结果具有较好一致性;评估试剂的血清转化灵敏度同参比试剂相当。结论北京科美生物技术有限公司的人类免疫缺陷病毒抗原抗体(HIVAg/Ab)检测试剂盒(光激化学发光法)与已上市同品种试剂盒检测结果具有一致性,血清转换灵敏度较高,有利于筛查HIV早期感染,为临床HIV早期诊断提供有效的实验室诊断依据。Objective To evaluate the consistency and seroconversion sensitivity of the human immunodeficiency virus antigen and antibody(HIV Ag/Ab) detection kit made by Beijing Chemclin Diagnostics(Group) with the four generations of HIV detection kits on the market.Methods 363 serum samples were collected for the study,including subjects of HIV patients,healthy person,rheumatoid factor samples,pregnancy samples,ANA positive samples,hepatitis B and hepatitis C patients and other interference samples.In addition,120 serum samples in 10 sets of HIV seroconversion panel were also included.Using LiCA 500 automatic light initiated Chemiluminescent assay instrument and matching reagents,calibrators,quality control and detection parameters reagents to detect serum HIV p24 antigen and qualitative HIV 1/2 antibody,so to evaluate its consistency with the results of reference reagents and the sensitivity of serum transformation.Results The results of serum samples detected by the human immunodeficiency virus antigen antibody kit(HIV Ag/Ab)and the reference reagent of Beijing Chemclin Diagnostics(Group) were in a good consistency.The sensitivity of the evaluation reagent for seroconversion was 1 day earlier than that of the reference reagent on average.Conclusion The detection kit of human immunodeficiency virus antigen and antibody(HIV Ag/Ab) made by Beijing Chemclin Diagnostics(Group) is in consistency with the similar products on the market.The sensitivity of serum conversion is qualified for screening the early HIV infection and can provide an effective laboratory diagnostic basis for the early clinical HIV diagnosis.

关 键 词：人类免疫缺陷病毒抗原抗体(HIV Ag/Ab)检测试剂盒(光激化学发光法) HIV p24抗原和HIV1/2抗体 结果一致性 血清转换灵敏度 

分 类 号：R51[医药卫生—内科学]