Al-Shobaili Hani, Hassanein Khaled M, Mostafa Marwa Salah, Al Duways Ali Saleh
Department of Dermatology, College of Medicine, Qassim University, Buraydah, Kingdom of Saudi Arabia.
J Clin Lab Anal. 2015 Jan;29(1):43-6. doi: 10.1002/jcla.21725. Epub 2014 Mar 28.
A rapid point-of-care test with high sensitivity and specificity is required in order to fulfill the need for early detection and screening of Herpes simplex virus type 2 (HSV-2) infection among patients with genital ulcer disease (GUD), for better management and control of virus transmission.
The goal of this study is to evaluate the performance of the commercially available HerpeSelect Express rapid test in comparison with three ELISA assays: HerpeSelect ELISA, Kalon HSV-2 glycoprotein G2 assay, and monoclonal antibody blocking enzyme immunoassay, which was used as the gold standard for the detection of HSV-2 antibodies.
This study showed high sensitivity (ranging from 82.6 to 100%) and specificity (100%) of the HerpeSelect Express rapid test when compared to the three ELISA assays. The agreement between the HerpeSelect Express rapid test with the three ELISAs ranged from 93.3 to 100%.
The HerpeSelect Express rapid test has adequate sensitivity and specificity for confirming HSV-2 infection in patients with GUD, indicating its suitability for epidemiological studies.
为满足对生殖器溃疡疾病（GUD）患者进行单纯疱疹病毒2型（HSV - 2）感染早期检测和筛查的需求，以更好地管理和控制病毒传播，需要一种具有高灵敏度和特异性的即时检测方法。
本研究的目的是评估市售的HerpeSelect Express快速检测与三种酶联免疫吸附测定（ELISA）方法的性能比较：HerpeSelect ELISA、Kalon HSV - 2糖蛋白G2测定法和单克隆抗体阻断酶免疫测定法，后者被用作检测HSV - 2抗体的金标准。
与三种ELISA测定法相比，本研究显示HerpeSelect Express快速检测具有高灵敏度（范围为82.6%至100%）和特异性（100%）。HerpeSelect Express快速检测与三种ELISA之间的一致性范围为93.3%至100%。
HerpeSelect Express快速检测在确认GUD患者的HSV - 2感染方面具有足够的灵敏度和特异性，表明其适用于流行病学研究。
