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新型微流控免疫磁珠凝集法检测登革病毒 NS1 抗原的评价。

Evaluation of a novel microfluidic immuno-magnetic agglutination assay method for detection of dengue virus NS1 antigen.

机构信息

Department of Clinical Microbiology, Hospital Clinic, Barcelona, Spain.

ISGlobal, Barcelona Centre for International Health Research (CRESIB), Hospital Clinic, Universitat de Barcelona, Barcelona, Spain.

出版信息

PLoS Negl Trop Dis. 2020 Feb 18;14(2):e0008082. doi: 10.1371/journal.pntd.0008082. eCollection 2020 Feb.

DOI:10.1371/journal.pntd.0008082
PMID:32069280
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7048294/
Abstract

BACKGROUND

Dengue virus (DENV) is the most important arbovirus worldwide, causing infections in endemic countries and returning travellers from these areas. Rapid diagnostic tests are needed to improve patient management and monitor local transmission. The detection of DENV non-structural protein 1 (NS1) is a useful tool for the diagnosis, but the currently available methods can be time consuming or lack sensitivity. The objective of our study was to evaluate a new rapid and semi-quantitative microfluidic DENV NS1 immuno-magnetic agglutination assay based on aggregation of magnetic nanoparticles detected by an electronic reader (Virotrack Dengue Acute and Blubox, Blusense diagnostics, Copenhagen, Denmark).

METHODOLOGY/PRINCIPAL FINDINGS: A panel of 135 serum samples from travelers returning from dengue endemic countries was analyzed (74 DENV positive samples including the four DENV serotypes, 26 Zika virus positive samples, 25 chikungunya virus positive samples, 5 malaria positive samples and 5 negative samples). Samples were tested by three different antigen detection methods: SD Dengue NS1 Ag ELISA, SD BIOLINE Dengue Duo and ViroTrack Dengue Acute. The sensitivity observed for SD Dengue NS1 Ag ELISA, ViroTrack Dengue Acute and SD BIOLINE Dengue Duo was 97.2%, 91.1% and 68.1%, respectively. All methods showed high specificity (98.4% for ViroTrack Dengue Acute and 100% for both SD Dengue NS1 Ag ELISA and SD BIOLINE Dengue Duo). SD Dengue NS1 Ag ELISA and ViroTrack Dengue Acute only failed to detect samples positive for DENV-2.

CONCLUSIONS/SIGNIFICANCE: ViroTrack Dengue Acute is a sensitive and specific assay for DENV NS1 detection. It provides faster results than the ELISA method and a better performance than the rapid immunochromatographic tests. ViroTrack Dengue Acute could represent a valuable tool for rapid diagnosis of DENV infections in returning travellers from endemic countries.

摘要

背景

登革热病毒（DENV）是全球最重要的虫媒病毒，在流行地区会引起感染，并使来自这些地区的旅行者返回时感染。需要快速诊断测试来改善患者管理并监测当地传播。检测登革热非结构蛋白 1（NS1）是诊断的有用工具，但目前可用的方法可能耗时或缺乏敏感性。我们的研究目的是评估一种新的快速半定量微流控登革热 NS1 免疫磁珠凝集检测法，该方法基于电子读取器检测到的磁性纳米颗粒聚集（Virotrack Dengue Acute 和 Blubox，Blusense diagnostics，哥本哈根，丹麦）。

方法/主要发现：分析了一组来自登革热流行国家的旅行者的 135 份血清样本（74 份 DENV 阳性样本，包括四种 DENV 血清型，26 份寨卡病毒阳性样本，25 份基孔肯雅病毒阳性样本，5 份疟疾阳性样本和 5 份阴性样本）。使用三种不同的抗原检测方法对样本进行检测：SD Dengue NS1 Ag ELISA、SD BIOLINE Dengue Duo 和 ViroTrack Dengue Acute。SD Dengue NS1 Ag ELISA、ViroTrack Dengue Acute 和 SD BIOLINE Dengue Duo 的灵敏度分别为 97.2%、91.1%和 68.1%。所有方法均表现出高特异性（ViroTrack Dengue Acute 为 98.4%，SD Dengue NS1 Ag ELISA 和 SD BIOLINE Dengue Duo 均为 100%）。SD Dengue NS1 Ag ELISA 和 ViroTrack Dengue Acute 仅未能检测到 DENV-2 阳性样本。

结论/意义：ViroTrack Dengue Acute 是一种用于 DENV NS1 检测的灵敏且特异的方法。与 ELISA 方法相比，它提供了更快的结果，并且比快速免疫层析检测法具有更好的性能。ViroTrack Dengue Acute 可能成为从流行地区返回的旅行者中快速诊断 DENV 感染的有价值工具。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/989a/7048294/d3bcb0ff9be8/pntd.0008082.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/989a/7048294/eb8f149c10df/pntd.0008082.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/989a/7048294/d3bcb0ff9be8/pntd.0008082.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/989a/7048294/eb8f149c10df/pntd.0008082.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/989a/7048294/d3bcb0ff9be8/pntd.0008082.g002.jpg

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