Disposable Autonomous Device for Rapid Swab-to-Result Diagnosis of Influenza
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 o...
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Published in | Analytical chemistry (Washington) Vol. 89; no. 11; pp. 5776 - 5783 |
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Main Authors | , , , , , , , , , , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
08.05.2017
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Online Access | Get full text |
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Summary: | 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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ISSN: | 0003-2700 1520-6882 |
DOI: | 10.1021/acs.analchem.6b04801 |