浙江省抗HIV抗体盲样质控考核结果分析及不同品牌分析灵敏度比较  

Analysis of HIV antibody results from the quality control of blind samples in Zhejiang province and comparison of the analysis sensitivity from different brands of kits

作　　者：宋超[1] 单志明[1] 康凤凤[1] 陈倩 郦卫星[1] SONG Chao;SHAN Zhiming;KANG Fengfeng;CHEN Qian;LI Weixing(Zhejiang Center for Clinical Laboratories, Zhejiang Provin- cial People＇s Hospital, People＇s Hospital Affiliated to Hangzhou Medical College, Hangzhou 310014, Zhejiang, China)

机构地区：[1]浙江省人民医院杭州医学院附属人民医院浙江省临床检验中心,杭州310014

出　　处：《临床检验杂志》2018年第7期532-535,共4页Chinese Journal of Clinical Laboratory Science

基　　金：浙江省医药卫生科技项目(2018KY006)

摘　　要：目的调查医疗机构选用不同方法学检测抗HIV抗体的能力情况,比较不同品牌和方法学对抗HIV抗体和抗原的分析灵敏度。方法定制6个不同浓度的抗HIV-1抗体标准物质,对218家实验室开展盲样质控考核,统计医院满分率、项目脱靶率和方法学脱靶率。采用3种不同稀释液对定制标准物质倍比稀释,获得低浓度抗HIV-1抗体和HIV-p24抗原标准物质,对考核中的6款化学发光品牌和3款ELISA品牌进行分析灵敏度的比较以及稀释液的影响比较。结果医院满分率为95.9%(209/218),抗HIV-1抗体项目脱靶率为1.8%,均为假阴性脱靶。ELISA、化学发光法(CLIA)和胶体金法(GICA)的脱靶率分别为0、13.3%和40.0%。在抗HIV-1抗体浓度为1 NCU/m L时3款CLIA品牌不能检出,1款CLIA品牌不能检出2 NCU/m L的抗体浓度。2款GICA品牌不能检出12 NCU/m L的抗体浓度。3、4代ELISA和3代CLIA品牌对抗HIV-1抗体检测的分析灵敏度优于部分4代CLIA品牌,而4代CLIA品牌对HIV-p24抗原的分析灵敏度显著高于4代ELISA。不同稀释液对检测结果影响存在显著差异,但不影响定性结果判断。结论 GICA检测抗HIV抗体存在较高的漏检风险。4代CLIA对HIV抗原检测分析灵敏度较高,但对抗HIV抗体检测的分析灵敏度相对弱于ELISA和3代试剂。稀释液的差异不是免疫定性分析的主要影响因素。Objective To investigate the ability of different medical institutions to detect HIV antibodies,and compare the analysis sensitivity of different brands of kits for HIV antibodies and antigens. Methods Six different concentrations of HIV-1 antibody standard substances were customized,and distributed to 218 laboratories to perform the quality control of blind samples. The full score rate and the miss rates of item and methodology were calculated.The HIV-1 antibody and HIV-p24 standard substances were diluted to low concentrations with 3 different diluents,and the analysis sensitivity of 6 chemiluminescent brands and 3 ELISA brands of kits and the influence of different diluents were compared.Results The full score rate was 95.9%（ 209/218）. The miss rate of HIV-1 antibody item was 1.8%,and all of miss were false negative. The miss rates of ELISA,chemiluminescence（ CLIA） and the gold immunochromatography assay（ GICA） were 0,13.3% and 40.0%,respectively. Three CLIA brands of kits couldn＇t detect 1 NCU/m L of HIV-1 antibody and 1 couldn＇t detect 2 NCU/m L of HIV-1 antibody. Two GICA brands of kits couldn＇t detect 12 NCU/m L of HIV-1 antibody. The sensitivity of the third and fourth generation ELISA and the third generation CLIA brands of kits to detect HIV-1 antibody were higher than that of some the fourth generation CLIA brands,while the sensitivity of the fourth generation CLIA brands of kits to detect HIV-p24 antigen were significantly higher than that of the fourth generation ELISA. There was significant effects of different diluents on the determination results,but they didn＇t affect the qualitative results.Conclusion There is a high risk of false negative detection for GICA. The analysis sensitivity of the fourth generation CLIA is high for the detection of HIV antigen,but is lower than that of ELISA and the third generation CLIA for the detection of HIV antibody.The difference of diluents is not the main influence factor of qualitative immunoassay.

关 键 词：人免疫缺陷病毒 窗口期 化学发光法 灵敏度 酶联免疫吸附试验 

分 类 号：R446.6[医药卫生—诊断学]