Journal
ANALYTICAL CHEMISTRY
Volume 89, Issue 11, Pages 5777-5784Publisher
AMER CHEMICAL SOC
DOI: 10.1021/acs.analchem.6b04801
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Funding
- NIH [R01AI096184]
- Directorate For Engineering
- Div Of Chem, Bioeng, Env, & Transp Sys [1450187] Funding Source: National Science Foundation
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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 specithens. The total test time from device initiation to result was approximately 35 min. Device performance for influenza A detection was similar to 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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