Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.
Institute for Public Health, National Institutes of Health, Ministry of Health, Setia Alam, Selangor, Malaysia.
BMC Infect Dis. 2020 Mar 12;20(1):210. doi: 10.1186/s12879-020-4911-5.
Dengue is an emerging infectious disease that infects up to 390 million people yearly. The growing demand of dengue diagnostics especially in low-resource settings gave rise to many rapid diagnostic tests (RDT). This study evaluated the accuracy and utility of ViroTrack Dengue Acute - a new biosensors-based dengue NS1 RDT, SD Bioline Dengue Duo NS1/IgM/IgG combo - a commercially available RDT, and SD Dengue NS1 Ag enzyme-linked immunosorbent assay (ELISA), for the diagnosis of acute dengue infection.
This prospective cross-sectional study consecutively recruited 494 patients with suspected dengue from a health clinic in Malaysia. Both RDTs were performed onsite. The evaluated ELISA and reference tests were performed in a virology laboratory. The reference tests comprised of a reverse transcription-polymerase chain reaction and three ELISAs for the detection of dengue NS1 antigen, IgM and IgG antibodies, respectively. The diagnostic performance of evaluated tests was computed using STATA version 12.
The sensitivity and specificity of ViroTrack were 62.3% (95%CI 55.6-68.7) and 95.0% (95%CI 91.7-97.3), versus 66.5% (95%CI 60.0-72.6) and 95.4% (95%CI 92.1-97.6) for SD NS1 ELISA, and 52.4% (95%CI 45.7-59.1) and 97.7% (95%CI 95.1-99.2) for NS1 component of SD Bioline, respectively. The combination of the latter with its IgM and IgG components were able to increase test sensitivity to 82.4% (95%CI 76.8-87.1) with corresponding decrease in specificity to 87.4% (95%CI 82.8-91.2). Although a positive test on any of the NS1 assays would increase the probability of dengue to above 90% in a patient, a negative result would only reduce this probability to 23.0-29.3%. In contrast, this probability of false negative diagnosis would be further reduced to 14.7% (95%CI 11.4-18.6) if SD Bioline NS1/IgM/IgG combo was negative.
The performance of ViroTrack Dengue Acute was comparable to SD Dengue NS1 Ag ELISA. Addition of serology components to SD Bioline Dengue Duo significantly improved its sensitivity and reduced its false negative rate such that it missed the fewest dengue patients, making it a better point-of-care diagnostic tool. New RDT like ViroTrack Dengue Acute may be a potential alternative to existing RDT if its combination with serology components is proven better in future studies.
登革热是一种新兴的传染病，每年感染人数多达 3.9 亿人。在资源匮乏的环境中，对登革热诊断的需求不断增长，这促使了许多快速诊断检测（RDT）的出现。本研究评估了 ViroTrack Dengue Acute（一种新的基于生物传感器的登革热 NS1 RDT）、SD Bioline Dengue Duo NS1/IgM/IgG 组合（一种市售 RDT）和 SD Dengue NS1 Ag 酶联免疫吸附试验（ELISA）在诊断急性登革热感染方面的准确性和实用性。
这是一项前瞻性的病例对照研究，连续招募了马来西亚一家诊所的 494 名疑似登革热患者。两种 RDT 均在现场进行。评估的 ELISA 和参考检测均在病毒学实验室进行。参考检测包括逆转录-聚合酶链反应和三种用于检测登革热 NS1 抗原、IgM 和 IgG 抗体的 ELISA。使用 STATA 版本 12 计算评估测试的诊断性能。
ViroTrack 的灵敏度和特异性分别为 62.3%（95%CI 55.6-68.7）和 95.0%（95%CI 91.7-97.3），而 SD NS1 ELISA 的灵敏度和特异性分别为 66.5%（95%CI 60.0-72.6）和 95.4%（95%CI 92.1-97.6），SD Bioline 的 NS1 组件的灵敏度和特异性分别为 52.4%（95%CI 45.7-59.1）和 97.7%（95%CI 95.1-99.2）。后两者与其 IgM 和 IgG 成分的组合能够将检测的灵敏度提高到 82.4%（95%CI 76.8-87.1），同时特异性降低到 87.4%（95%CI 82.8-91.2）。尽管任何一种 NS1 检测的阳性结果都会使患者患登革热的概率超过 90%，但阴性结果只会将该概率降低到 23.0-29.3%。相比之下，如果 SD Bioline NS1/IgM/IgG 组合为阴性，假阴性诊断的概率将进一步降低至 14.7%（95%CI 11.4-18.6）。
ViroTrack Dengue Acute 的性能与 SD Dengue NS1 Ag ELISA 相当。在 SD Bioline Dengue Duo 中添加血清学成分显著提高了其灵敏度，并降低了其假阴性率，从而使它漏诊的登革热患者最少，使其成为更好的即时诊断工具。如果像 ViroTrack Dengue Acute 这样的新型 RDT 在未来的研究中被证明与血清学成分的组合更好，那么它可能成为现有 RDT 的一种替代选择。
