Pandemic strains of influenza have arisen in the past and will unquestionably arise in the future. Numerous respiratory viruses, including common influenza strains and pandemic strains, present with essentially identical generalized symptoms. A public health and clinical concern is distinguishing between patients infected with pandemic influenza or a common respiratory virus, to do so requires a sensitive diagnostic system. HT-FilmArray technology provides a dense format to concurrently assay for a panel of respiratory viruses including influenza but to also characterize the influenza H and N genes to differentiate strains (e.g. H5N1). HT-FilmArray employs a plastic disposable in which is performed a seamless progression of biochemical manipulations including: nucleic acid preparation, reverse transcription, PCR using a 2-stage nested multiplex process, and confirmation of product identity by high-resolution melt profiling. Nested PCR while exquisitely sensitive, has seen limited use as it is prone to amplicon contamination. HT-FilmArray contains the nested procedure such that its greatest strength (sensitivity) is realized while its greatest weakness (amplicon contamination) is eliminated. High-resolution melt profiling is used to confirm positive results. Melt profiling rapidly determines curve shape and melting temperature as a 2nd tier analysis to re-enforce positive results and to eliminate false positive results. In a pandemic scenario, communication between laboratories will enable clinicians to better diagnose patients and provide public health officials information to take steps that will contain the outbreak. Proposed is a software module allowing HT- FilmArray users, even in geographically remote locations, to communicate and share data over a secure internet connection. This data sharing module will enable privileged users to view runs in real-time from remote locations and for independent data sets to be shared and analyzed together. A data mining module will allow results to be analyzed together and provide a flexible format for data comparison. Data sharing/data mining will allow public health officials to monitor viral activity using data from multiple distantly located HT-FilmArray instruments and based upon the data make sound decisions to contain an outbreak. While this proposal is focused upon influenza, HT-FilmArray will be equally useful as a standard tool to assess patients during yearly respiratory virus epidemics.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01AI074419-05
Application #
8117719
Study Section
Special Emphasis Panel (ZAI1-CCH-M (M1))
Program Officer
Krafft, Amy
Project Start
2007-08-15
Project End
2012-07-31
Budget Start
2011-08-01
Budget End
2012-07-31
Support Year
5
Fiscal Year
2011
Total Cost
$1,206,303
Indirect Cost
Name
Biofire Diagnostics, Inc.
Department
Type
DUNS #
556915205
City
Salt Lake City
State
UT
Country
United States
Zip Code
84108
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Stockmann, Chris; Ampofo, Krow; Byington, Carrie L et al. (2013) Pneumococcal meningitis in children: epidemiology, serotypes, and outcomes from 1997-2010 in Utah. Pediatrics 132:421-8
Blaschke, Anne J; Heyrend, Caroline; Byington, Carrie L et al. (2012) Rapid identification of pathogens from positive blood cultures by multiplex polymerase chain reaction using the FilmArray system. Diagn Microbiol Infect Dis 74:349-55
Doby, Elizabeth H; Benjamin Jr, Daniel K; Blaschke, Anne J et al. (2012) Therapeutic monitoring of voriconazole in children less than three years of age: a case report and summary of voriconazole concentrations for ten children. Pediatr Infect Dis J 31:632-5

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