Centre for Communicable Diseases Research, Institute for Public Health, National Institutes of Health, Ministry of Health, Persiaran Setia Murni, Setia Alam, Shah Alam 40170, Selangor, Malaysia.
Department of Medical Microbiology, Faculty of Medicine, University of Malaya, Jalan Profesor Diraja Ungku Aziz, Kuala Lumpur 50603, Malaysia.
Biosensors (Basel). 2021 Apr 22;11(5):129. doi: 10.3390/bios11050129.
Dengue is a major threat to public health globally. While point-of-care diagnosis of acute/recent dengue is available to reduce its mortality, a lack of rapid and accurate testing for the detection of previous dengue remains a hurdle in expanding dengue seroepidemiological surveys to inform its prevention, especially vaccination, to reduce dengue morbidity. This study evaluated ViroTrack Dengue Serostate, a biosensors-based semi-quantitative anti-dengue IgG (immunoglobulin G) immuno-magnetic agglutination assay for the diagnosis of previous and recent dengue in a single test. Blood samples were obtained from 484 healthy participants recruited randomly from two communities in Petaling district, Selangor, Malaysia. The reference tests were Panbio Dengue IgG indirect and capture enzyme-linked immunosorbent assays, in-house hemagglutination inhibition assay, and focus reduction neutralization test. Dengue Serostate had a sensitivity and specificity of 91.1% (95%CI 87.8-93.8) and 91.1% (95%CI 83.8-95.8) for the diagnosis of previous dengue, and 90.2% (95%CI 76.9-97.3) and 93.2% (95%CI 90.5-95.4) for the diagnosis of recent dengue, respectively. Its positive predictive value of 97.5% (95%CI 95.3-98.8) would prevent most dengue-naïve individuals from being vaccinated. ViroTrack Dengue Serostate's good point-of-care diagnostic accuracy can ease the conduct of dengue serosurveys to inform dengue vaccination strategy and facilitate pre-vaccination screening to ensure safety.
登革热是全球公共卫生的主要威胁。虽然即时护理诊断急性/近期登革热的方法可降低死亡率，但缺乏快速准确的检测方法来检测以前的登革热仍然是扩大登革热血清流行病学调查以告知其预防措施，特别是疫苗接种，以降低登革热发病率的一个障碍。本研究评估了 ViroTrack Dengue Serostate，这是一种基于生物传感器的半定量抗登革热 IgG（免疫球蛋白 G）免疫磁凝集检测试剂盒，用于单次检测既往和近期登革热。从马来西亚雪兰莪州八打灵区两个社区随机招募了 484 名健康参与者，采集了他们的血液样本。参考测试是 Panbio Dengue IgG 间接和捕获酶联免疫吸附试验、内部血凝抑制试验和焦点减少中和试验。Dengue Serostate 对既往登革热的诊断灵敏度和特异性分别为 91.1%（95%CI 87.8-93.8）和 91.1%（95%CI 83.8-95.8），对近期登革热的诊断灵敏度和特异性分别为 90.2%（95%CI 76.9-97.3）和 93.2%（95%CI 90.5-95.4）。其 97.5%（95%CI 95.3-98.8）的阳性预测值可防止大多数无登革热经验的个体接种疫苗。ViroTrack Dengue Serostate 的良好即时护理诊断准确性可以简化登革热血清学调查的开展，为登革热疫苗接种策略提供信息，并促进疫苗接种前的筛查，以确保安全性。
