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基于激光切割纸片的假病毒颗粒捕获抗原检测试剂盒用于检测基孔肯雅病毒特异性 IgM。

Detection of chikungunya virus-specific IgM on laser-cut paper-based device using pseudo-particles as capture antigen.

机构信息

bioMérieux, Innovations New Immuno-Concepts department, Chemin de l'Orme, Marcy-l'Etoile, France.

Unité des Virus Emergents (UVE: Aix-Marseille Univ, IRD 190, Inserm 1207, IHU Méditerranée Infection), Marseille, France.

出版信息

J Med Virol. 2019 Jun;91(6):899-910. doi: 10.1002/jmv.25420. Epub 2019 Feb 8.

DOI:10.1002/jmv.25420
PMID:30734316
Abstract

The incidence of arbovirus infections has increased dramatically in recent decades, affecting hundreds of millions of people each year. The Togaviridae family includes the chikungunya virus (CHIKV), which is typically transmitted by Aedes mosquitoes and causes a wide range of symptoms from flu-like fever to severe arthralgia. Although conventional diagnostic tests can provide early diagnosis of CHIKV infections, access to these tests is often limited in developing countries. Consequently, there is an urgent need to develop efficient, affordable, simple, rapid, and robust diagnostic tools that can be used in point-of-care settings. Early diagnosis is crucial to improve patient management and to reduce the risk of complications. A glass-fiber laser-cut microfluidic device (paper-based analytical device [PAD]) was designed and evaluated in a proof of principle context, for the analysis of 30 µL of patient serum. Biological raw materials used for the functionalization of the PAD were first screened by MAC-ELISA (IgM capture enzyme-linked immunosorbent assay) for CHIKV Immunoglobulin M (IgM) capture and then evaluated on the PAD using various human samples. Compared with viral lysate traditionally used for chikungunya (CHIK) serology, CHIKV pseudo-particles (PPs) have proven to be powerful antigens for specific IgM capture. The PAD was able to detect CHIKV IgM in human sera in less than 10 minutes. Results obtained in patient sera showed a sensitivity of 70.6% and a specificity of around 98%. The PAD showed few cross-reactions with other tropical viral diseases. The PAD could help health workers in the early diagnosis of tropical diseases such as CHIK, which require specific management protocols in at-risk populations.

摘要

虫媒病毒感染的发病率在最近几十年内急剧上升,每年影响数亿人。披膜病毒科包括基孔肯雅病毒(CHIKV),它通常由埃及伊蚊传播,引起从流感样发热到严重关节痛等各种症状。尽管传统的诊断检测方法可以提供 CHIKV 感染的早期诊断,但在发展中国家,获得这些检测方法的机会往往有限。因此,迫切需要开发高效、经济实惠、简单、快速且强大的诊断工具,以便在现场进行检测。早期诊断对于改善患者管理和降低并发症风险至关重要。在原理验证的背景下,设计并评估了一种玻璃纤维激光切割微流控装置(纸基分析装置 [PAD]),用于分析 30µL 的患者血清。用于 PAD 功能化的生物原材料首先通过 MAC-ELISA(IgM 捕获酶联免疫吸附测定)进行筛选,以捕获 CHIKV 免疫球蛋白 M(IgM),然后在各种人类样本上在 PAD 上进行评估。与传统用于基孔肯雅(CHIK)血清学的病毒裂解物相比,CHIKV 假型颗粒(PPs)已被证明是用于特异性 IgM 捕获的有效抗原。PAD 能够在不到 10 分钟的时间内检测到人类血清中的 CHIKV IgM。在患者血清中获得的结果显示出 70.6%的敏感性和约 98%的特异性。PAD 与其他热带病毒病的交叉反应较少。PAD 可以帮助卫生工作者在高危人群中对 CHIK 等热带疾病进行早期诊断,这些疾病需要特定的管理方案。

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