摘要
探讨ELISA检测乙肝表面抗原(HBsAg)弱阳性标本的复检策略。采用ELISA双孔检测法、化学发光免疫分析法及胶体金免疫层析法复查149例ELISA初检HBsAg弱阳性标本。比较这三种方法的检测灵敏度、特异性以及临床实用价值。结果显示,ELISA法复查149例HBsAg弱阳性标本中,仅81例阳性,与化学发光法比较,结果无显著性差异,一致性检验Kappa值为0.864;以化学发光法与ELISA检测一致的结果为标准,金标法检测HBsAg弱阳性标本灵敏度为87%,特异性达到95%,能够满足临床HBsAg弱阳性标本复查要求;化学发光法较前两者具有更高的特异性及灵敏度,影响因素小,准确性高,临床研究多将其作为参考方法,缺点是其试剂成本高。因此,我们依据各检测方法特点,并针对不同的干扰因素,综合考虑临床需要和经济效益,合理制定HBsAg弱阳性标本的复查策略。
To discuss the clinical application of methods for rechecking the weak hepatitis B surface antigen (HBsAg) positive samples detected by ELISA daily, with special interest on reducing false positive rate and false negative rate and improving the detection sensitivity and specificity, 149 serum samples with weak positive results of HBsAg were measured simultaneously by ELISA, ehemiluminesent immunoassay and colloidal gold immunochromatography (GICA). We found that when the samples were rechecked by ELISA strictly following operation procedures, 89 of the 149 samples were positive. There was no statisti- cally significant difference between ELISA and chemiluminesent immunoassay assay for HBsAg detection, suggesting existence of a good correlation (Kappa= 0. 864). With consistent results of chemiluminescence and ELISA detection as standard, the sensitivity of GICA was 87% and the specificity was 95%. The sensitivity and the specificity of chemiluminesent immunoassaywere significantly higher than ELISA and GICA. Compared with ELISA and GICA, chemiluminesent immunoassay had the characteristic of higher sensitivity and specificity, less influenced as well as higher accuracy. It is used as the reference assay in clinical practice, but its reagents are expensive. Consequently, we propose that for rechecking the weak positive results of HB sAg, we should choose cost effective methods, accordingly based on the different interference factors and the characteristics of the testing methods.
出处
《现代免疫学》
CAS
CSCD
北大核心
2013年第5期412-416,共5页
Current Immunology
基金
国家自然基金项目(81101557)