Kacaki J, Wolters G, Kuijpers L, Stulemeyer S
Vox Sang. 1978 Jul-Aug;35(1-2):65-74. doi: 10.1111/j.1423-0410.1978.tb02902.x.
The results obtained in a multicentre clinical trial of an enzyme immunoassay (EIA) method for hepatitis B surface antigen (HBsAg) (65,451 sera tested) have demonstrated that this new test has a significantly higher sensitivity than a reversed haemagglutination test (rHA). In a part of the trial, EIA was also compared with radioimmunoassay (RIA). Only a small number of discrepant results was obtained with these two tests, indicating similar sensitivities. No definite conclusion about a difference in sensitivities could be drawn from these results. Although the specificity of the EIA screening test is lower than that of rHA and RIA, the mean percentage of false positives was 2.2% of the total number of donor samples screened. Presumptive positives in EIA were subjected to a confirmatory test based on neutralization with human antibodies to HBsAg. After elimination of false positives in EIA screening, there was excellent agreement between EIA and RIA results.
一项针对乙肝表面抗原（HBsAg）的酶免疫测定法（EIA）的多中心临床试验结果（检测了65451份血清）表明，这项新检测方法的灵敏度显著高于反向血凝试验（rHA）。在该试验的一部分中，还将EIA与放射免疫测定法（RIA）进行了比较。这两种检测方法仅获得了少量不一致的结果，表明它们的灵敏度相似。从这些结果中无法得出关于灵敏度差异的明确结论。尽管EIA筛查试验的特异性低于rHA和RIA，但假阳性的平均百分比占所筛查供血者样本总数的2.2%。EIA中的推定阳性样本接受了基于用人抗HBsAg抗体进行中和的确认试验。在消除EIA筛查中的假阳性后，EIA和RIA的结果高度一致。
