Program Director/Principal Investigator (Last, First, Middle): DobfOWOlski, Steven Francis PROJECT SUMMARY (See instructions): FilmArray is an emerging technology that concurrently tests for panels of pathogens and genetic mutations, while also providing a broad regimen of controls. Testing utilizes a simplified, pouch-base system that contains all reagents in a stabilized, freeze-dried format. A clinical sample (nasal wash, vaginal swab, etc) is combined with a guanidinium solution and injected into the FilmArraypouch. The pouch contains all reagents required to prepare nucleic acids, amplify gene targets using a novel 2-stage nested multiplex system, collect real-time PCR data, and perform post-PCR melting to detect mutations. TheFilmArray system (instrument and reagents) provide a seamless and simplified system to concurrently test for multiple pathogens. Modifications are proposed to the FilmArrayinstrument that will provide """"""""ruggedization"""""""" making it compatible with frequent transport and the rigors of non-traditional testing venues. The instrument will be adapted to function with alternative power sources including generators and power derived from a vehicle. Instrument validation will be performed with an existing FilmArraytest that concurrently assesses 18 respiratory viruses. A FilmArraypouch will be developed to test for the following sexually transmitted infections: N. gonorrhoeae, T. vaginalis, C. trachomatis, M. genitalium, U. urealyticum, U. parvum, HSV1, HSV2, T. pallidum, and a set of mutations leading to drug resistance in N. gonorrhoeae. The point-of-care adapted FilmArray instrument and tests that assay foreither respiratory infections or sexually transmitted infections will be utilized in on-traditional medical setings. The respiratory testing panel is used in a family-based,prospective cohort study using atypical sampling to assess respiratory virus infections over one year. Additionally the respiratory pathogen test will be used in diseaster scenarios within elementary schools and in a community wide setting. The STItest will be deployed in the urban 4th Street Homeless Clinic to provide testing for STI's to the homeless population in Salt Lake City. Assessments of the modified point-of-care FilmArray instrument and associates reagents will demonstrate the feasibility to use this platform in nontraditional medical settings to perform broad pathogen testing.

Public Health Relevance

FilmArray is an emergingtechnology to concurrently test broad panels pathogens using disposablereagents. A """"""""ruggedized""""""""and portable FilmArray instrumentis developed for nontraditional settings. FilmArray pouches testingfor respiratory infectionsand sexually transmitted infectionswill be developed.The system (instrument, chemistry) is evaluated in non-traditional settingscreating a prescident for sophisticated testing in atvniral PROJECT/

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01AI082482-04
Application #
8298457
Study Section
Special Emphasis Panel (ZAI1-LR-M (J2))
Program Officer
David, Hagit S
Project Start
2009-07-01
Project End
2013-06-30
Budget Start
2012-07-01
Budget End
2013-06-30
Support Year
4
Fiscal Year
2012
Total Cost
$885,081
Indirect Cost
$293,449
Name
Biofire Diagnostics, Inc.
Department
Type
DUNS #
556915205
City
Salt Lake City
State
UT
Country
United States
Zip Code
84108
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