Kruining J, Mulder P G, Heijtink R A
Department of Virology, Erasmus University Rotterdam, The Netherlands.
J Virol Methods. 1988 Oct;22(1):89-98. doi: 10.1016/0166-0934(88)90091-2.
In the first part of this study anti-HBs developed after vaccination (three different vaccines, sampling at four time intervals after the first injection) or infection (n = 342) was simultaneously tested by Ausab-RIA and Ausab-EIA (Abbot Laboratories). For each vaccination subgroup (vaccine, time) the geometric mean level (GML) of anti-HBs, expressed in IU/l using the Abbott reference panel, was calculated. The ratio GML-RIA/GML-EIA ranged from 1.4 to 2.2. Differences between the vaccine subgroups were found at months 2/3 and month 7, but not at months 12 and 24. The results obtained in convalescent sera by RIA and EIA were similar (ratio GML 1.1). It is concluded that the behaviour of anti-HBs based on the Abbott reference panel differs from that of anti-HBs obtained after vaccination. In the second part of this study, we compared RIA (Abbott Laboratories) with two other EIAs (Organon Teknika): Hepanostika anti-HBs monoclonal (HM) and Hepanostika anti-HBs 'new' (HN). The suitability of these EIAs for detecting anti-HBs greater than 10 IU/l was investigated in sera obtained after vaccination and infection (n = 538). On the first screening, all samples with anti-HBs greater than 10 IU/l (n = 109) in the RIA were detected by HM, whereas 5-7%, dependent on the time of the first incubation step, were negative by HN. The functional sensitivity of HN was 3.9 IU/l (short incubation) or 1.5 IU/l (overnight incubation) and 16.1 IU/l for HM as determined with the Organon reference panel. Sera from three reference panels, as in-house panel, an Abbott panel and an Organon panel were tested in Ausab-RIA, HM and HN. For a serum with the arbitrarily chosen level of 50 IU/l anti-HBs (in-house panel) the results of the in-house panel, the Abbott panel and the Organon panel deviated less by the Ausab-RIA. Since in the Organon-EIAs extreme values of 77 and 35 IU/l were calculated with the Abbott and the Organon panel, respectively, the need for reference sera, the use of which is not related to any particular test system, is stressed once again.
在本研究的第一部分，通过澳抗 - RIA法（雅培实验室）和澳抗 - EIA法，对疫苗接种（三种不同疫苗，首次注射后四个时间间隔采样）或感染（n = 342）后产生的抗 - HBs进行同步检测。对于每个疫苗接种亚组（疫苗、时间），使用雅培参考标准品，计算以IU/l表示的抗 - HBs几何平均水平（GML）。GML - RIA/GML - EIA的比值范围为1.4至2.2。在第2/3个月和第7个月发现疫苗亚组之间存在差异，但在第12个月和第24个月未发现差异。通过RIA法和EIA法在恢复期血清中获得的结果相似（GML比值为1.1）。得出结论，基于雅培参考标准品的抗 - HBs行为与疫苗接种后获得的抗 - HBs行为不同。在本研究的第二部分，我们将RIA法（雅培实验室）与另外两种EIA法（欧加农公司）进行比较：肝炎诊断抗 - HBs单克隆法（HM）和肝炎诊断抗 - HBs“新”法（HN）。在疫苗接种和感染后获得的血清（n = 538）中，研究了这些EIA法检测抗 - HBs大于10 IU/l的适用性。在首次筛查中，RIA法检测出抗 - HBs大于10 IU/l的所有样本（n = 109）均被HM法检测到，而HN法有5 - 7%（取决于首次孵育步骤的时间）为阴性。根据欧加农参考标准品测定，HN法的功能灵敏度为3.9 IU/l（短孵育）或1.5 IU/l（过夜孵育），HM法为16.1 IU/l。在澳抗 - RIA法、HM法和HN法中对来自三个参考标准品的血清进行检测，这三个参考标准品分别为内部标准品、雅培标准品和欧加农标准品。对于内部标准品中任意选定的抗 - HBs水平为50 IU/l的血清，内部标准品、雅培标准品和欧加农标准品的结果在澳抗 - RIA法中偏差较小。由于在欧加农EIA法中，分别用雅培标准品和欧加农标准品计算出的极值为77 IU/l和35 IU/l，因此再次强调需要使用与任何特定检测系统无关的参考血清。
