Clinical trial NCT02232711: Evaluation of Accuracy and Ease of Use of the FilmArray™ Respiratory Panel (RP EZ) in a CLIA-Waived Clinical Setting
Official title: Evaluation of Accuracy and Ease of Use of the FilmArray™ Respiratory Panel (RP EZ) in a CLIA-Waived Clinical Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Upper Respiratory Infections
Keywords: multiplex, polymerase chain reaction, PCR, BioFire, respiratory infection, infectious disease, point of care, CLIA waived, rapid diagnostics
Lead sponsor: BioFire Diagnostics, LLC
Sponsor class: INDUSTRY
Collaborators: name: United States Department of Defense
First posted: 2014-09-05
Enrollment: 1082
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with signs and/or symptoms of respiratory infections

Brief summary: The purpose of this study is to assess the accuracy and ease-of-use of a simplified FilmArray Respiratory Panel test (FilmArray RP EZ) when performed according to the manufacturer's instructions by personnel in laboratories holding Clinical Laboratory Improvement Amendments (CLIA) waivers (or equivalent) on nasopharyngeal swab samples obtained from volunteers with signs and/or symptoms of a respiratory infection. The study data will be used to support an application to the FDA for CLIA-waived categorization of FilmArray RP EZ. It is hypothesized that the results of the FilmArray RP EZ test performed in a laboratory with CLIA waiver with be 95% accurate when compared to FilmArray RP testing performed in a lab with a moderate or high complexity CLIA certification.


Eligibility criteria: Inclusion Criteria:

* Displays signs and/or symptoms of respiratory infections
* Adult patients must provide informed consent
* Parental consent for children (\<18)

Exclusion Criteria:

* Adult patients unable to provide informed consent
* Children that are currently in foster care, or are wards of the state

Primary outcomes:
measure: Accuracy of FilmArray RP EZ System in detecting cause of respiratory illness
timeFrame: 1.5 hour
Secondary outcomes:
measure: Epidemiology of respiratory infections in a CLIA-waived setting
timeFrame: Up to 9 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Health Research Center
state: California
city: St. Louis
country: United States
facility: Barnes-Jewish/Washington University School of Medicine
state: Missouri
city: Galveston
country: United States
facility: UTMB Primary Care Pavilion
state: Texas
city: Salt Lake City
country: United States
facility: South Main Clinic
state: Utah
Study officials:
References:
citation: Barenfanger J, Drake C, Leon N, Mueller T, Troutt T. Clinical and financial benefits of rapid detection of respiratory viruses: an outcomes study. J Clin Microbiol. 2000 Aug;38(8):2824-8. doi: 10.1128/JCM.38.8.2824-2828.2000.
citation: Buller RS. Molecular detection of respiratory viruses. Clin Lab Med. 2013 Sep;33(3):439-60. doi: 10.1016/j.cll.2013.03.007.
citation: Fairfax MR, Salimnia H. Diagnostic molecular microbiology: a 2013 snapshot. Clin Lab Med. 2013 Dec;33(4):787-803. doi: 10.1016/j.cll.2013.08.003.