Department of Global Health, University of Washington, Seattle, Washington, USA.
Sex Transm Infect. 2011 Apr;87(3):238-41. doi: 10.1136/sti.2010.047415. Epub 2011 Feb 9.
To compare the performance of the Focus HerpeSelect-2 enzyme immunoassay (EIA) with the gold standard herpes simplex virus (HSV) type 2 western blot, among HIV-1-uninfected men and women in east and southern Africa.
3399 HIV-1-uninfected women and men from seven countries in east and southern Africa were tested for HSV-2 antibody using the Focus HerpeSelect-2 EIA. The performance of the HerpesSelect-2 EIA was compared with the gold standard HSV-2-specific western blot.
Two-thirds (2294/3399) of participants were male and two-thirds (2242/3399) were from east Africa. By western blot testing, HSV-2 prevalence was 68%; 59% in men and 85% in women. At the manufacturer's recommended cut-off value of greater than 1.1, the HerpeSelect-2 EIA had a sensitivity of 98.3% and specificity of 80.3%. Receiver operating characteristic plot analysis indicated that the optimum cut-off was 2.1 or greater, with sensitivity 93.9% and specificity 90.5%. Diagnostic accuracy was modestly higher for southern Africa (area under the curve (AUC) 0.979, 95% CI 0.970 to 0.988) compared with east Africa (AUC 0.954, 95% CI 0.942 to 0.965; p<0.001 for southern vs east Africa).
The Focus HerpeSelect-2 EIA has acceptable diagnostic accuracy for the determination of HSV-2 serostatus in African HIV-1-uninfected adults. An assay cut-off value of 2.1 or greater results in approximately 90% sensitivity and specificity, against a gold standard HSV-2 western blot. Diagnostic accuracy differed slightly by geographical region.
比较 Focus HerpeSelect-2 酶免疫分析（EIA）与单纯疱疹病毒 2 型（HSV-2）western 印迹的金标准在东非和南非的 HIV-1 未感染者中的表现。
对来自东非和南非七个国家的 3399 名 HIV-1 未感染者使用 Focus HerpeSelect-2 EIA 检测 HSV-2 抗体。将 HerpesSelect-2 EIA 的性能与 HSV-2 特异性 western 印迹的金标准进行比较。
研究对象中，三分之二（2294/3399）为男性，三分之二（2242/3399）来自东非。通过 western 印迹检测，HSV-2 流行率为 68%；男性为 59%，女性为 85%。在制造商推荐的大于 1.1 的截止值下，HerpeSelect-2 EIA 的敏感性为 98.3%，特异性为 80.3%。受试者工作特征曲线分析表明，最佳截止值为 2.1 或更高，敏感性为 93.9%，特异性为 90.5%。与东非（曲线下面积（AUC）0.954，95%CI 0.942 至 0.965）相比，南部非洲（AUC 0.979，95%CI 0.970 至 0.988）的诊断准确性略高（南部 vs 东部非洲；p<0.001）。
Focus HerpeSelect-2 EIA 对确定非洲 HIV-1 未感染者的 HSV-2 血清状态具有可接受的诊断准确性。使用 2.1 或更高的检测截止值可获得约 90%的敏感性和特异性，与 HSV-2 western 印迹的金标准相比。诊断准确性在地理区域上略有差异。
