国际医药卫生导报
國際醫藥衛生導報
국제의약위생도보
INTERNATIONAL MEDICINE & HEALTH GUIDANCE NEWS
2009年
12期
85-87
,共3页
刘云锋%陈曲波%刘海英%关启鸿%蒋涛%张建
劉雲鋒%陳麯波%劉海英%關啟鴻%蔣濤%張建
류운봉%진곡파%류해영%관계홍%장도%장건
乙肝表面抗体%酶联免疫吸附法%化学发光
乙肝錶麵抗體%酶聯免疫吸附法%化學髮光
을간표면항체%매련면역흡부법%화학발광
HBsAb%ELISA%Chemiluminescence
目的 探讨浓度处于5～100mIU/ml的乙肝表面抗体(HBsAb)ELISA定性检测与化学发光法的符合情况.方法 采用10种国产主流HBsAb ELISA试剂对127例经用化学发光法检测已知HBsAb浓度的标本进行检测,分析ELISA检测OD值与抗体浓度的相关性,并以试剂盒临界值为准分别比较不同OD值段ELISA结果 与化学发光法结果 的符合率.结果 10种同产HBsAb ELISA试剂盒OD值与化学发光定最值均呈正相关(P<0.01);ELISA法检测结果 与化学发光的阴阳符合率比较显示,5～10mIU/ml样本符合率较低,只有37.5%,在大于100mIU/ml时可达99.4%,在10～30mIU/ml,30～100mIU/ml分别为75.3%和90.7%;OD值存0～0.05,0.05～0.105、0.105～0.21、0.21～0.3、0.3～0.5、大于0.5分别为73.4%、65.3%、60.5%、72.0%、86.5%、92.2%.结果 显示阴阳结果 符合率在较高在大于0.5时最高,在介于0.105～0.21的符合率最低;处于试剂盒临界值±20%处的标本的符合率普遍偏低,最低只有42%,最高亦不超过80%.结论 虽然10种国产ELISA试剂之间的检测结果 没有统计学差异,但是对于浓度介于5～10mIU/ml标本符合率低.而且在接近试剂盒临界值时与化学发光结果 符合率则很低,但是随着OD值的增高符合率也逐渐升高.考虑到乙肝表面抗体的特殊临床意义,如何选取一个更为科学客观的结果 判断临界值值得进一步探讨.
目的 探討濃度處于5～100mIU/ml的乙肝錶麵抗體(HBsAb)ELISA定性檢測與化學髮光法的符閤情況.方法 採用10種國產主流HBsAb ELISA試劑對127例經用化學髮光法檢測已知HBsAb濃度的標本進行檢測,分析ELISA檢測OD值與抗體濃度的相關性,併以試劑盒臨界值為準分彆比較不同OD值段ELISA結果 與化學髮光法結果 的符閤率.結果 10種同產HBsAb ELISA試劑盒OD值與化學髮光定最值均呈正相關(P<0.01);ELISA法檢測結果 與化學髮光的陰暘符閤率比較顯示,5～10mIU/ml樣本符閤率較低,隻有37.5%,在大于100mIU/ml時可達99.4%,在10～30mIU/ml,30～100mIU/ml分彆為75.3%和90.7%;OD值存0～0.05,0.05～0.105、0.105～0.21、0.21～0.3、0.3～0.5、大于0.5分彆為73.4%、65.3%、60.5%、72.0%、86.5%、92.2%.結果 顯示陰暘結果 符閤率在較高在大于0.5時最高,在介于0.105～0.21的符閤率最低;處于試劑盒臨界值±20%處的標本的符閤率普遍偏低,最低隻有42%,最高亦不超過80%.結論 雖然10種國產ELISA試劑之間的檢測結果 沒有統計學差異,但是對于濃度介于5～10mIU/ml標本符閤率低.而且在接近試劑盒臨界值時與化學髮光結果 符閤率則很低,但是隨著OD值的增高符閤率也逐漸升高.攷慮到乙肝錶麵抗體的特殊臨床意義,如何選取一箇更為科學客觀的結果 判斷臨界值值得進一步探討.
목적 탐토농도처우5～100mIU/ml적을간표면항체(HBsAb)ELISA정성검측여화학발광법적부합정황.방법 채용10충국산주류HBsAb ELISA시제대127례경용화학발광법검측이지HBsAb농도적표본진행검측,분석ELISA검측OD치여항체농도적상관성,병이시제합림계치위준분별비교불동OD치단ELISA결과 여화학발광법결과 적부합솔.결과 10충동산HBsAb ELISA시제합OD치여화학발광정최치균정정상관(P<0.01);ELISA법검측결과 여화학발광적음양부합솔비교현시,5～10mIU/ml양본부합솔교저,지유37.5%,재대우100mIU/ml시가체99.4%,재10～30mIU/ml,30～100mIU/ml분별위75.3%화90.7%;OD치존0～0.05,0.05～0.105、0.105～0.21、0.21～0.3、0.3～0.5、대우0.5분별위73.4%、65.3%、60.5%、72.0%、86.5%、92.2%.결과 현시음양결과 부합솔재교고재대우0.5시최고,재개우0.105～0.21적부합솔최저;처우시제합림계치±20%처적표본적부합솔보편편저,최저지유42%,최고역불초과80%.결론 수연10충국산ELISA시제지간적검측결과 몰유통계학차이,단시대우농도개우5～10mIU/ml표본부합솔저.이차재접근시제합림계치시여화학발광결과 부합솔칙흔저,단시수착OD치적증고부합솔야축점승고.고필도을간표면항체적특수림상의의,여하선취일개경위과학객관적결과 판단림계치치득진일보탐토.
Objective To compare the difference between ELISA and chemiluminescence assay in de-tecting hepatitis B surface antibody (HBsAb) serum valued in 5～100mIU/ml. Method 127 HBsAb serum samples that had valued by chemiluminescence were detected using 10 domestic ELISA kits. The correlation between the results of ELISA kits and chemiluminescence assay were analyzed. Coincidence between the results of ELISA kits and chemiluminescence at different OD value range were also analyzed. Results The detected results between 10 domestic ELISA kits and chemiluminescence assay are positive correlation (P<0.01); The optimal coincidence rates of the results of ELISA with those samples valued by chemiluminescence at more than 100mIU/ml was 99.4%; the coinci-dence rate is from 42% to 80% in cut-off±20%. The average coincidence rate is under 60%. Conclusions Though the detected results of 10 domestic ELISA reagents is related closely, the coincidence rate of the results at 5～10mIU/ ml in detecting anti-HBs is low. So it is important to make a positive standard in detecting anti-HBs.
