127例乙肝表面抗体ELISA检测与化学发光法的比较

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.

Comparison between ELISA and chemiluminescence assay in detecting Hepatitis B surface-anti-body

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.