Disposable Autonomous Device for Swab-to-Result Diagnosis of Influenza.
Disposable Autonomous Device for Swab-to-Result Diagnosis of Influenza.
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DOI：
10.1021/acs.analchem.6b04801
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发表时间：
2017-06-06
影响因子：
7.4
通讯作者：
Yager P
中科院分区：
文献类型：
--
作者：
Huang S;Abe K;Bennett S;Liang T;Ladd PD;Yokobe L;Anderson CE;Shah K;Bishop J;Purfield M;Kauffman PC;Paul S;Welch AE;Strelitz B;Follmer K;Pullar K;Sanchez-Erebia L;Gerth-Guyette E;Domingo G;Klein E;Englund JA;Fu E;Yager P
开发了一种用于鼻拭子标本中流感病毒化学扩增蛋白检测的独立、自动化、一次性装置原型，并在临床环境中进行了评价。该设备只需要简单的标本操作，无需任何专用仪器或操作员进行专门的解释培训。该装置基于流感病毒核蛋白的夹心免疫测定;它使用酶标记抗体和显色底物以二维纸网络格式提供放大的可见信号。所有试剂均储存在器械内。设备性能在西雅图儿童医院进行了评估;临床工作人员从25名患者中采集鼻拭子样本，然后现场操作测试设备检测这些样本中的甲型和B型流感病毒。从器械启动到获得结果的总测试时间约为35分钟。使用内部qRT-PCR甲型流感病毒作为金标准比较，甲型流感病毒检测的器械性能准确度为≥ 70%。有效器械运行与总完成器械运行的比率产生的成功率为92%，甲型流感和B流感检测试剂的阴性预测值均为81%。快速诊断呼吸道感染并靠近患者的能力受到医院工作人员的好评，激发了设备功能的进一步优化。
A prototype of a self-contained, automated, disposable device for chemically-amplified protein-based detection of influenza virus from nasal swab specimens was developed and evaluated in a clinical setting. The device required only simple specimen manipulation without any dedicated instrumentation or specialized training by the operator for interpretation. The device was based on a sandwich immunoassay for influenza virus nucleoprotein; it used an enzyme-labeled antibody and a chromogenic substrate to provide an amplified visible signal, in a two-dimensional paper network format. All reagents were stored within the device. Device performance was assessed at Seattle Children's Hospital; clinical staff collected nasal swab samples from 25 patients, and then operated test devices on site to detect influenza A and B in those specimens. The total test time from device initiation to result was approximately 35 minutes. Device performance for influenza A detection was ∼70% accurate using in-house qRT-PCR influenza A as a gold-standard comparison. The ratio of valid to total completed device runs yielded a success rate of 92%, and the negative predictive value for both the influenza A and B assay was 81%. The ability to diagnose respiratory infections rapidly and close to the patient was well received by hospital staff, inspiring further optimization of device function.
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影响因子：
7.4
作者：
Grant BD;Smith CA;Karvonen K;Richards-Kortum R
通讯作者：
Richards-Kortum R
影响因子：
9.4
作者：
Kuypers, Jane;Wright, Nancy;Morrow, Rhoda
通讯作者：
Morrow, Rhoda
影响因子：
3.3
作者：
Taubenberger, Jeffery K.;Morens, David M.
通讯作者：
Morens, David M.
影响因子：
4.4
作者：
Bose, Michael E.;Sasman, Amy;Henrickson, Kelly J.
通讯作者：
Henrickson, Kelly J.
影响因子：
6.1
作者：
Parolo, Claudio;Medina-Sanchez, Mariana;Merkoci, Arben
通讯作者：
Merkoci, Arben