McCready J A, Morens D, Fields H A, Coleman P J, Kane M, Schatz G
Hepatitis Branch, Centers for Disease Control, Atlanta, Georgia 30333.
Epidemiol Infect. 1991 Dec;107(3):673-84. doi: 10.1017/s0950268800049372.
Commercially available kits for detection of hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) by enzyme immunoassay (EIA) were evaluated in American Samoa during a public health programme to eliminate the transmission of hepatitis B. The first 19,184 serum specimens obtained, representing 68% of the total cooperating population, were initially tested for anti-HBs, and those without detectable antibody were tested for HBsAg. All the antigen-positive serum samples, and a selection of the antigen- and antibody-negative specimens were tested by radioimmunoassay (RIA) for detection of both markers. Compared with the standard tests, the EIA kits for anti-HBs and HBsAg performed well; sensitivity and specificity were 90.3 and 96.0%, respectively, for antibody, and 97.8 and 97.9% respectively for antigen. Substantial disagreement between the EIA and RIA tests for HBsAg was found only for specimens considered weakly reactive by EIA. Few differences were found between three EIA method options for follow-up HBsAg testing of weakly reactive serum specimens; each option contributed about equally to improved test specificity for these 'borderline' specimens. Based on their demonstrated equivalence to the standard RIA tests, we conclude that the EIA kits for anti-HBs and HBsAg detection are suitable for use in hepatitis B control programmes in open populations.
在美属萨摩亚的一项消除乙肝传播的公共卫生项目中，对通过酶免疫测定法（EIA）检测乙肝表面抗原（HBsAg）和乙肝表面抗体（抗-HBs）的市售试剂盒进行了评估。最初获得的19,184份血清标本占总合作人群的68%，首先检测抗-HBs，未检测到抗体的标本再检测HBsAg。所有抗原阳性血清样本以及部分抗原和抗体阴性标本通过放射免疫测定法（RIA）检测这两种标志物。与标准检测相比，抗-HBs和HBsAg的EIA试剂盒表现良好；抗体检测的灵敏度和特异性分别为90.3%和96.0%，抗原检测的灵敏度和特异性分别为97.8%和97.9%。仅在EIA检测认为反应较弱的标本中发现EIA和RIA检测HBsAg之间存在较大差异。对于反应较弱的血清标本进行后续HBsAg检测的三种EIA方法选项之间几乎没有差异；每种选项对提高这些“临界”标本的检测特异性贡献大致相同。基于其与标准RIA检测的等效性，我们得出结论，用于检测抗-HBs和HBsAg的EIA试剂盒适用于开放人群的乙肝控制项目。
