1Division of Infectious Diseases and Tropical Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
2Division of Dengue Hemorrhagic Fever Research, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
Am J Trop Med Hyg. 2021 Jul 19;105(3):771-776. doi: 10.4269/ajtmh.20-1558.
Dengue (DENV) infections are a public health concern worldwide and thus early diagnosis is important to ensure appropriate clinical management. The rapid diagnostic test (RDT) targets nonstructural protein 1 (NS1) detection and is the main tool used for diagnostic purpose. In this study, we evaluated the performance of a new rapid and semi-quantitative microfluidic DENV NS1 immuno-magnetic agglutination assay or IMA (ViroTrack Dengue Acute, BluSense Diagnostics, Copenhagen, Denmark). We studied 233 subjects confirmed to have DENV infection (by a real-time reverse transcriptase polymerase chain reaction) and 200 control samples were taken from patients with confirmed diagnoses of other febrile illnesses, in Thailand. Samples were tested using the NS1 antigen (Ag) detection methods: in-house NS1 Ag ELISA (ELISA), SD BIOLINE Dengue NS1 Ag RDT (ICT), and ViroTrack Dengue Acute (IMA). Sensitivities of these tests were 86.3%, 78.9%, and 85.5%, respectively. All tests showed high specificity (100%, 99%, and 97% for ELISA, ICT, and IMA, respectively). The sensitivities of both RDTs were affected by the low sensitivity to DENV-2 and DENV-4. NS1 Ag was detected in every patient on day 1 and day 2 after onset of illness by ELISA and IMA with a decline in detection rates over time after day 6 of illness. NS1 detection rate using ICT decreased from 100% on day 1 of illness to 98.6% on day 2 after onset of illness. By day 6, the detection rate was 45.9%. Thus, IMA performed better than ICT for early and rapid diagnosis of DENV infections in endemic countries.
登革热（DENV）感染是全球公共卫生关注的问题，因此早期诊断对于确保适当的临床管理非常重要。快速诊断测试（RDT）针对非结构蛋白 1（NS1）的检测，是用于诊断目的的主要工具。在这项研究中，我们评估了一种新的快速半定量微流控登革热 NS1 免疫磁性凝集检测或 IMA（ViroTrack Dengue Acute，BluSense Diagnostics，哥本哈根，丹麦）的性能。我们研究了 233 名经实时逆转录聚合酶链反应证实患有登革热感染的患者，200 名对照样本取自泰国经确诊患有其他发热性疾病的患者。使用 NS1 抗原（Ag）检测方法检测样本：内部 NS1 Ag ELISA（ELISA）、SD BIOLINE Dengue NS1 Ag RDT（ICT）和 ViroTrack Dengue Acute（IMA）。这些测试的灵敏度分别为 86.3%、78.9%和 85.5%。所有测试均显示出高特异性（ELISA、ICT 和 IMA 的特异性分别为 100%、99%和 97%）。两种 RDT 的灵敏度均受到对 DENV-2 和 DENV-4 的低灵敏度的影响。登革热感染后第 1 天和第 2 天，ELISA 和 IMA 均可检测到每个患者的 NS1 Ag，随着疾病发作后第 6 天的推移，检测率下降。登革热感染后第 1 天，ICT 的 NS1 检测率为 100%，第 2 天为 98.6%，第 6 天为 45.9%。因此，IMA 比 ICT 更适合在登革热流行国家进行早期和快速诊断登革热感染。
