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Vastly improved influenza diagnostics through the development of a handheld thermal contrast reader

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41NR017825-01A1
Agency Tracking Number: R41NR017825
Amount: $300,939.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 600
Solicitation Number: PA16-303
Timeline
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-09-27
Award End Date (Contract End Date): 2019-08-31
Small Business Information
822 FAIRMOUNT AVE
Saint Paul, MN 55105-3340
United States
DUNS: 079812159
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 JOHN BISCHOF
 (612) 625-5513
 bischof@umn.edu
Business Contact
 MICHAEL LOTTI
Phone: (651) 402-0810
Email: lotti010@umn.edu
Research Institution
 UNIVERSITY OF MINNESOTA
 
100 CHURCH ST SE
MINNEAPOLIS, MN 55455-0149
United States

 Nonprofit College or University
Abstract

VIGILANT DIAGNOSTICS
NIAID NIH STTR Phase I Application
Vastly improved influenza diagnostics through the development of a portable thermal contrast reader
PROJECT SUMMARY ABSTRACT
Despite recent advances in rapid influenza diagnostic tests false negatives stemming from poor sensitivity
contribute to nosocomial transmission and prevent thousands from receiving appropriate antiviral treatment
Among vulnerable populations the consequences can be grave The population under five years of age
experienced hospitalization rates of with influenza associated pediatric deaths during the
influenza season and deaths in the pandemic Influenza associated hospitalization rates were
for those years and for those over years
We have developed a desktop system that uses a thermal contrast assay TCA reader to detect gold
nanoparticles used in nearly all lateral flow assays LFAs for influenza With this TCA reader we have
demonstrated an fold improvement in sensitivity over results from the industry leading handheld BD Veritor
system in a flu A antigen dilution study We propose to begin commercializing this TCA reader technology by
Building a prototype portable TCA reader that is functionally equivalent to the existing desktop TCA reader and
Testing this prototype portable TCA reader alongside an existing visual flu LFA i e BD Veritor or other
system the desktop TCA reader and polymerase chain reaction PCR testing in a clinical setting To build a
prototype of the portable TCA reader we will first test and validate new and cheaper handheld components for
functional equivalency with the corresponding fully characterized component in the desktop TCA reader We will
then assemble the parts with a custom designed LFA holder into a functioning portable TCA reader Further we
will work to develop proprietary Windows based software and algorithms for control of the prototype The
prototype TCA reader will be tested on up to discarded influenza LFAs We will also compare to the
corresponding nasopharyngeal samples that generated the LFAs to allow for correlative gold standard PCR
testing The visual results of these LFAs will be known We will then test the visually negative LFAs with the
portable TCR reader prototype After the corresponding nasopharyngeal swabs undergo PCR testing all results
will be compared
This portable TCA reader system will then be a prototype for a low cost high sensitivity easy to use point
of care influenza diagnostic system that will reduce false negatives over today s industry leading handheld BD
Veritor and other visual based flu LFAs VIGILANT DIAGNOSTICS
NIAID NIH STTR Phase I Application
Vastly improved influenza diagnostics through the development of a portable thermal contrast reader
PROJECT NARRATIVE
Early detection of influenza contributes to improved patient care reduced hospital admissions reduced
transmission and better public health management Despite recent advances however the best early
detection tests and reader for influenza on the market have low sensitivity roughly and thus a high rate
of false negative results We propose to develop our innovative and highly effective thermal contrast
amplification technology to build a low cost easy to use portable influenza detection system that will
significantly reduce false negative results

* Information listed above is at the time of submission. *

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