检验医学
檢驗醫學
검험의학
LABORATORY MEDICINE
2013年
11期
1040-1043
,共4页
简敏华%张健%陈慧英%蒋玲丽%陆银华%肖艳群%邵维杰%徐罛
簡敏華%張健%陳慧英%蔣玲麗%陸銀華%肖豔群%邵維傑%徐罛
간민화%장건%진혜영%장령려%륙은화%초염군%소유걸%서고
乙型肝炎病毒血清标志物%胶体金免疫层析法%化学发光免疫测定法%酶联免疫吸附试验
乙型肝炎病毒血清標誌物%膠體金免疫層析法%化學髮光免疫測定法%酶聯免疫吸附試驗
을형간염병독혈청표지물%효체금면역층석법%화학발광면역측정법%매련면역흡부시험
Hepatitis B virus serological marker%Colloidal gold immunochromatography assay%Chemiluminescence immunoassay%Enzyme-linked immunosorbent assay
目的：评估乙型肝炎病毒血清标志物（HBV-M）胶体金免疫层析法（GICA）的分析性能。方法收集雅培i1000免疫检测系统检测的HBV-M阳性标本653例、阴性标本103例和HBV-M标准品，以化学发光免疫测定法（CLIA）检测结果为标准，分别用酶联免疫吸附试验（ELISA）试剂和5种GICA试剂检测，统计分析检测结果。结果检测HBV-M敏感性：ELISA和GICA检测HBV-M的最低检测限分别为乙型肝炎表面抗原（HBsAg）0．5 IU/mL和4～8 IU/mL、乙型肝炎表面抗体（抗 HBs）10 mIU/mL 和15～30 mIU/mL、乙型肝炎 e 抗原（HBeAg）1 NCU/mL和2～4 NCU/mL、乙型肝炎e抗体（抗HBe）2 NCU/mL和64～256 NCU/mL、乙型肝炎核心抗体（抗HBc）2 IU/mL和32～256 IU/mL。检测标本HBV-M的符合率：ELISA分别为87．4％、99．0％、87．7％、96．6％、100．0％，GICA分别为69．6％～71．7％、69．0％～72．0％、70．5％～73．9％、42．2％～49．1％、50．0％～60．0％。检测HBV-M特异性：除GICA检测抗HBs的特异性略差外，其余各HBV-M的检测特异性均是可接受。结论 GICA检测HBV-M低浓度的标本，漏检率很高，只能用于GICA检测线性范围里HBsAg的筛查，不能作为临床诊断乙型肝炎和疗效考核的依据。
目的：評估乙型肝炎病毒血清標誌物（HBV-M）膠體金免疫層析法（GICA）的分析性能。方法收集雅培i1000免疫檢測繫統檢測的HBV-M暘性標本653例、陰性標本103例和HBV-M標準品，以化學髮光免疫測定法（CLIA）檢測結果為標準，分彆用酶聯免疫吸附試驗（ELISA）試劑和5種GICA試劑檢測，統計分析檢測結果。結果檢測HBV-M敏感性：ELISA和GICA檢測HBV-M的最低檢測限分彆為乙型肝炎錶麵抗原（HBsAg）0．5 IU/mL和4～8 IU/mL、乙型肝炎錶麵抗體（抗 HBs）10 mIU/mL 和15～30 mIU/mL、乙型肝炎 e 抗原（HBeAg）1 NCU/mL和2～4 NCU/mL、乙型肝炎e抗體（抗HBe）2 NCU/mL和64～256 NCU/mL、乙型肝炎覈心抗體（抗HBc）2 IU/mL和32～256 IU/mL。檢測標本HBV-M的符閤率：ELISA分彆為87．4％、99．0％、87．7％、96．6％、100．0％，GICA分彆為69．6％～71．7％、69．0％～72．0％、70．5％～73．9％、42．2％～49．1％、50．0％～60．0％。檢測HBV-M特異性：除GICA檢測抗HBs的特異性略差外，其餘各HBV-M的檢測特異性均是可接受。結論 GICA檢測HBV-M低濃度的標本，漏檢率很高，隻能用于GICA檢測線性範圍裏HBsAg的篩查，不能作為臨床診斷乙型肝炎和療效攷覈的依據。
목적：평고을형간염병독혈청표지물（HBV-M）효체금면역층석법（GICA）적분석성능。방법수집아배i1000면역검측계통검측적HBV-M양성표본653례、음성표본103례화HBV-M표준품，이화학발광면역측정법（CLIA）검측결과위표준，분별용매련면역흡부시험（ELISA）시제화5충GICA시제검측，통계분석검측결과。결과검측HBV-M민감성：ELISA화GICA검측HBV-M적최저검측한분별위을형간염표면항원（HBsAg）0．5 IU/mL화4～8 IU/mL、을형간염표면항체（항 HBs）10 mIU/mL 화15～30 mIU/mL、을형간염 e 항원（HBeAg）1 NCU/mL화2～4 NCU/mL、을형간염e항체（항HBe）2 NCU/mL화64～256 NCU/mL、을형간염핵심항체（항HBc）2 IU/mL화32～256 IU/mL。검측표본HBV-M적부합솔：ELISA분별위87．4％、99．0％、87．7％、96．6％、100．0％，GICA분별위69．6％～71．7％、69．0％～72．0％、70．5％～73．9％、42．2％～49．1％、50．0％～60．0％。검측HBV-M특이성：제GICA검측항HBs적특이성략차외，기여각HBV-M적검측특이성균시가접수。결론 GICA검측HBV-M저농도적표본，루검솔흔고，지능용우GICA검측선성범위리HBsAg적사사，불능작위림상진단을형간염화료효고핵적의거。
Objective To evaluate the performance of colloidal gold immunochromatography assay (GICA)for the determination of the serological markers of hepatitis B virus (HBV-M).Methods Abbott i1 000 immunoassay system detected 653 cases of HBV-M positive samples,and the results of 103 cases of HBV-M negative samples and HBV-M standard materials by chemiluminescence immunoassay (CLIA)were as the standard.Enzyme-linked immunosorbent assay (ELISA)reagent and 5 GICA reagents were used for the detection,and the results were analyzed statistically. Results The sensitivity for the determination of HBV-M was analyzed.ELISA and GICA detection limits for HBV-M showed that hepatitis B surface antigen (HBsAg)0.5 IU/mL and 4-8 IU/mL,anti-hepatitis B surface antigen antibody (anti-HBs)10 mIU/mL and 1 5-30 mIU/mL,hepatitis Be antigen (HBeAg)1 NCU/mL and 2-4 NCU/mL,anti-hepatitis Be antigen antibody (anti-HBe)2 NCU/mL and 64-256 IU/mL,anti-hepatitis B core antigen antibody (anti-HBc)2 IU/mL and 32-256 NCU/mL.The coincidence rates of HBV-M were 87.4%,99.0%,87.7%,96.6% and 1 00.0% by ELISA and were 69.6%-71 .7%,69.0%-72.0%,70.5%-73.9%,42.2%-49.1% and 50.0%-60.0%by GICA.Except the specificity for the determination of anti-HBs by GICA was slightly bad,the specificities of other HBV-M were acceptable.Conclusions GICA for the determination of HBV-M with low concentration has high missing rate.GICA can only be used for the screening HBsAg with linear range,and its results cannot be used for the clinical diagnosis and efficacy assessment of hepatitis B.
