Department of Biomedical Science, College of Health Sciences, Qatar University, Doha, Qatar; BioMedical Research Center, Qatar University, Doha, Qatar.
Infectious Disease Epidemiology Group, Weill Cornell Medicine-Qatar, Cornell University, Qatar Foundation - Education City, Doha, Qatar.
J Clin Virol. 2019 Feb;111:33-38. doi: 10.1016/j.jcv.2019.01.001. Epub 2019 Jan 7.
Assessments of commercial assays in detecting herpes simplex virus type 2 (HSV-2) antibodies have shown variable sensitivity and specificity, and variation in performance by global population.
To evaluate performance of four assays in detecting HSV-2 antibodies in a composite Middle Eastern and North African (MENA) population. The assays are two ELISA kits: HerpeSelect 2 ELISA IgG and Euroimmun Anti-HSV-2 (gG2) ELISA (IgG), and two immunoblot (IB)/Western blot (WB) assays: HerpeSelect 1 and 2 Immunoblot IgG and Euroimmun Anti-HSV-1/HSV-2 gG2 Euroline-WB (IgG/IgM).
Blood specimens were drawn from blood donors between 2013-2016 in Doha, Qatar. Twenty specimens from ten nationalities (Egypt, Iran, Jordan, Lebanon, Pakistan, Palestine, Qatar, Sudan, Syria, and Yemen; total = 200) were randomly selected and tested for HSV-2 antibodies.
In the six possible assay comparisons, Cohen's kappa statistics indicated fair to good agreement, ranging between 0.57 (95% CI 0.28-0.86) and 0.69 (95% CI 0.44-0.95). Meanwhile, positive percent agreement ranged between 50.0 (95% CI 18.7-81.3%) and 63.6% (95% CI 30.8-89.1%); negative percent agreement ranged between 97.8% (95% CI 94.4-99.4%) and 99.5% (95% CI 97.0-100.0%); and overall percent agreement ranged between 95.8% (95% CI 91.9-97.9%) and 97.5% (95% CI 94.2-98.9%). The two ELISA kits demonstrated comparable sensitivities and specificities ≥50% and >98%, respectively, with respect to the IB/WB assays.
The study provided, for the first time, primary data on performance of these assays in diagnosing HSV-2 infection in MENA populations. Findings support comparable performance and utility of these assays, and demonstrate challenges in establishing seropositivity (versus seronegativity).
对商业检测方法检测单纯疱疹病毒 2 型（HSV-2）抗体的评估表明，其敏感性和特异性存在差异，并且在全球人群中的表现也存在差异。
评估四种检测方法在中东和北非（MENA）混合人群中检测 HSV-2 抗体的性能。这四种检测方法包括两种酶联免疫吸附试验（ELISA）试剂盒：HerpeSelect 2 ELISA IgG 和 Euroimmun Anti-HSV-2（gG2）ELISA（IgG），以及两种免疫印迹（IB）/Western blot（WB）检测试剂盒：HerpeSelect 1 和 2 Immunoblot IgG 和 Euroimmun Anti-HSV-1/HSV-2 gG2 Euroline-WB（IgG/IgM）。
2013 年至 2016 年间，在卡塔尔多哈的献血者中采集了血液样本。从来自 10 个国家（埃及、伊朗、约旦、黎巴嫩、巴基斯坦、巴勒斯坦、卡塔尔、苏丹、叙利亚和也门）的 20 名献血者中随机选择了 20 份样本（共 200 份），用于检测 HSV-2 抗体。
在六种可能的检测方法比较中，Cohen's kappa 统计数据表明，一致性为中等至良好，范围在 0.57（95%置信区间 0.28-0.86）至 0.69（95%置信区间 0.44-0.95）之间。同时，阳性百分比一致性范围在 50.0%（95%置信区间 18.7-81.3%）至 63.6%（95%置信区间 30.8-89.1%）之间；阴性百分比一致性范围在 97.8%（95%置信区间 94.4-99.4%）至 99.5%（95%置信区间 97.0-100.0%）之间；总百分比一致性范围在 95.8%（95%置信区间 91.9-97.9%）至 97.5%（95%置信区间 94.2-98.9%）之间。两种 ELISA 试剂盒在与 IB/WB 检测方法比较时，均表现出相似的敏感性和特异性，分别为≥50%和>98%。
该研究首次提供了这些检测方法在 MENA 人群中诊断 HSV-2 感染的性能的初步数据。研究结果支持这些检测方法的可比性和实用性，并表明在确定血清阳性（而非血清阴性）方面存在挑战。
