Eing Bodo Rolf, Lippelt Lars, Lorentzen Eva Ulla, Hafezi Wali, Schlumberger Wolfgang, Steinhagen Katja, Kühn Joachim Ewald
Institute of Medical Microbiology, Clinical Virology, University of Muenster, Muenster. Euroimmun GmbH, Gross-Groenau, Germany.
J Clin Microbiol. 2002 Feb;40(2):407-13. doi: 10.1128/JCM.40.2.407-413.2002.
In this study, the optimal combination of three commercial glycoprotein G-2 (gG-2)-based herpes simplex virus type 2 (HSV-2) type-specific enzyme-linked immunosorbent assays (Euroimmun anti-HSV-2 immunoglobulin G [IgG] ELISA [Eu2], Gull HSV-2-specific IgG ELISA [Gu2], and Radim HSV-2 IgG ELISA [Ra2]) and one gG-2-based HSV-2-specific immunoblot (Euroimmun anti-HSV-1/HSV-2 gG Western blot [EuW]) was determined with regard to diagnostic performance and cost efficiency. Two hundred fifty serum samples were included in this study, 194 of which were from female prostitutes. When a formal primary "gold standard" was defined based on majority agreement of the commercial tests, with EuW being decisive in stand-off situations, the sensitivity and specificity of the assays in the samples from prostitutes were as follows: Eu2, 100 and 89.22%; Gu2, 94.44 and 96.08%; Ra2, 61.18 and 95.10%; and EuW, 98.90 and 100%. The most cost-effective confirmatory strategy in the samples from prostitutes was screening with Eu2, retesting positive and equivocal samples with Gu2, and resolving the remaining discordant results with EuW (estimated additional costs per sample, 79.02%; sensitivity, 100%; positive predictive value, 96.81%). Applying a self-developed gG-2-independent assay to the discordant and concordant negative samples in the samples from prostitutes suggested that the primary gold standard may have missed six HSV-2-positive samples. In conclusion, confirmatory strategies based on commercial gG-2-dependent seroassays result in an increase in the specificity of HSV-2-specific serology. However, further improvement of the sensitivity of current HSV-2-specific serology may require the additional exploitation of the gG-2-independent type-specific antibody response.
在本研究中，针对三种基于糖蛋白G-2（gG-2）的2型单纯疱疹病毒（HSV-2）型特异性酶联免疫吸附测定法（欧蒙抗HSV-2免疫球蛋白G [IgG] ELISA [Eu2]、古尔德HSV-2特异性IgG ELISA [Gu2]和拉迪姆HSV-2 IgG ELISA [Ra2]）以及一种基于gG-2的HSV-2特异性免疫印迹法（欧蒙抗HSV-1/HSV-2 gG免疫印迹法[EuW]）的最佳组合，在诊断性能和成本效益方面进行了测定。本研究纳入了250份血清样本，其中194份来自女性性工作者。当基于商业检测的多数一致性定义一个正式的主要“金标准”，在相持情况下以EuW为决定性标准时，这些检测方法在性工作者样本中的敏感性和特异性如下：Eu2，分别为100%和89.22%；Gu2，分别为94.44%和96.08%；Ra2，分别为61.18%和95.10%；以及EuW，分别为98.90%和100%。在性工作者样本中，最具成本效益的确认策略是先用Eu2进行筛查，对阳性和疑似阳性样本用Gu2重新检测，并用EuW解决其余不一致的结果（估计每份样本的额外成本为79.02%；敏感性为100%；阳性预测值为96.81%）。将一种自行开发的不依赖gG-2的检测方法应用于性工作者样本中不一致和一致的阴性样本，提示主要金标准可能遗漏了6份HSV-2阳性样本。总之，基于商业gG-2依赖性血清学检测的确认策略可提高HSV-2特异性血清学的特异性。然而，当前HSV-2特异性血清学敏感性的进一步提高可能需要额外利用不依赖gG-2的型特异性抗体反应。
