Sato K, Ichiyama S, Iinuma Y, Nada T, Shimokata K, Nakashima N
Department of Clinical Laboratory Medicine, Nagoya University Hospital, Japan.
J Clin Microbiol. 1996 Jun;34(6):1420-2. doi: 10.1128/jcm.34.6.1420-1422.1996.
We evaluated two immunochromatographic assays (ICAs), Dainascreen HBsAg for detecting human hepatitis hepatitis B surface antigen (HBsAg) and Dainascreen Ausab for detecting human hepatitis B surface antibody (anti-HBs) in human serum. The ICA systems are composed of a comb-shaped device that contains nitrocellulose strips on which complexes of HBsAg and anti-HBs can be visualized. The results can be read within 15 min of incubation. The limit of detection for HBsAg was 3.1 ng/ml and that for anti-HBs was 42 mIU/ml. Results of HBsAg detection agreed completely with those of conventional enzyme immunoassays (EIAs) and showed a 100% sensitivity (158 of 158 samples) and a 100% specificity (304 of 304 samples). The Dainascreen Ausab detected 184 of the 199 EIA-positive samples (sensitivity, 92.5%) and yielded 6 positive results among the 281 EIA-negative samples (specificity, 97.9%). The ICA systems are rapid and sensitive methods for detecting HBsAg and anti-HBs. They are low-cost systems that need no complex instrumentation for analysis and can be recommended for routine use in clinical microbiology laboratories.
我们评估了两种免疫层析法（ICA），即用于检测人血清中乙型肝炎表面抗原（HBsAg）的戴纳斯creen HBsAg和用于检测人乙型肝炎表面抗体（抗-HBs）的戴纳斯creen Ausab。ICA系统由一个梳状装置组成，该装置包含硝酸纤维素条带，在其上可以观察到HBsAg和抗-HBs的复合物。孵育15分钟内即可读取结果。HBsAg的检测限为3.1 ng/ml，抗-HBs的检测限为42 mIU/ml。HBsAg检测结果与传统酶免疫测定（EIA）结果完全一致，灵敏度为100%（158份样本中的158份），特异性为100%（304份样本中的304份）。戴纳斯creen Ausab在199份EIA阳性样本中检测出184份（灵敏度为92.5%），在281份EIA阴性样本中产生6份阳性结果（特异性为97.9%）。ICA系统是检测HBsAg和抗-HBs的快速灵敏方法。它们是低成本系统，无需复杂的仪器进行分析，可推荐用于临床微生物实验室的常规检测。
