Tuesday, April 29, 2025
4/29/2025
STI AND RESPIRATORY PATHOGEN TESTING IN NONTRADITIONAL SETTINGS - DESCRIPTION (provided by applicant): 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 FilmArray pouch. 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. The FilmArray system (instrument and reagents) provide a seamless and simplified system to concurrently test for multiple pathogens. Modifications are proposed to the FilmArray instrument 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 FilmArray test that concurrently assesses 18 respiratory viruses. A FilmArray pouch 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 settings. 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 disaster scenarios within elementary schools and in a community wide setting. The STI test 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.
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