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A sample-to-answer diagnostic cartridge that identifies influenza using a glucometer

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41AI126965-01
Agency Tracking Number: R41AI126965
Amount: $137,689.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIAID
Solicitation Number: PA15-270
Solicitation Year: 2016
Award Year: 2016
Award Start Date (Proposal Award Date): 2016-07-04
Award End Date (Contract End Date): 2017-06-30
Small Business Information
Austin, TX 78746-5634
United States
DUNS: 078669099
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (512) 245-1050
Business Contact
Phone: (512) 245-1050
Research Institution

Project Summary Abstract
Seasonal influenza has an annual global incidence of up to in adults and up to in children
About to million infections result in severe disease while somewhere between a quarter and a half million
cases are fatal Antiviral drugs can lessen the severity and reduce mortality when administered within h of
onset of symptoms Hence sensitive and specific point of care POC diagnostic tools especially those that
can be used at home can be invaluable in expediting appropriate therapy and mitigating viral spread While
TaqMan real time reverse transcriptase polymerase chain reaction RT PCR and viral culture continue to be
the diagnostic gold standards several rapid POC influenza diagnostic technologies have been
commercialized Although results are available within min most of these tests have poor sensitivity
compared to gold standards Rapid tests based on isothermal nucleic acid amplification Alere i influenza A
and B test have also recently become available and while they are very specific and sensitive they can be
too expensive for widespread POC use $ to $ per test and requiring the Alere i instrument that itself
costs about $ To reduce testing cost and make nucleic acid diagnostics more widely available for at
home testing we propose to develop a one pot robust and cheap POC test that can distinguish influenza A
and B viruses Key to this technology is viral RNA amplification by loop mediated isothermal amplification
LAMP and conversion of the resulting nucleic acid amplicons into glucose for readout via widely available
over the counter glucometers Overall in a partnership between Paratus Diagnostics and the Ellington lab at
the University of Texas at Austin we will develop a Paratus Consumable Cartridge PCC that will serve as an
all in one device that extracts amplifies and transduces pathogen genetic signatures from patient samples to
glucometers for readout and is projected to cost about $ device In particular we will develop reverse
transcription RT LAMP assays specific for the influenza A and B virus matrix genes Aim Objective and
transduce the amplicons into glucose via our novel patent pending sequence specific oligonucleotide strand
displacement OSD reporters Aim Objective We will automate the molecular assay on the PCC Aim
Objective and using biological samples perfect field appropriate sample extraction procedures requiring
only intuitive user input Aim Objective Diagnostic utility of the PCC and the molecular assay will be
demonstrated by comparing its robustness and its positive and negative predictive values with those of
TaqMan real time RT PCR when challenged with blinded surrogate clinical samples Aim Objective
These data will position the PCC based POC diagnostic for further validation with clinical samples and
eventually field trials Project Narrative
Cheap and portable influenza diagnostics will incentivize widespread use and thereby potentiate
effective treatment and better head off pandemics Our proposed isothermal amplification assays will
ultimately transduce only a few copies of viruses in unaltered biospecimens into the presence of glucose
which can in turn be read via commercially available hand held glucometers If successful nucleic acid
amplification assays for influenza can readily be reconfigured for other infectious and communicable diseases

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

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