Evaluation of Accuracy and Ease of Use of the FilmArray™ Respiratory Panel (RP EZ) in a CLIA-Waived Clinical Setting

Upper Respiratory Infections Clinical Trial

Official title:

Evaluation of Accuracy and Ease of Use of the FilmArray™ Respiratory Panel (RP EZ) in a CLIA-Waived Clinical Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02232711
• Other study ID #: SDY-014162
• Secondary ID: HDTRA1-09-C0068
• Status: Completed
• Phase: N/A
• First received: August 28, 2014
• Last updated: July 23, 2015
• Start date: November 2014
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: BioFire Diagnostics, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1082
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Respiratory Tract Infections
• Upper Respiratory Infections

Locations

Country	Name	City	State
United States	UTMB Primary Care Pavilion	Galveston	Texas
United States	South Main Clinic	Salt Lake City	Utah
United States	Naval Health Research Center	San Diego	California
United States	Barnes-Jewish/Washington University School of Medicine	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
BioFire Diagnostics, LLC	United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of FilmArray RP EZ System in detecting cause of respiratory illness	In general, performance of the FilmArray RP EZ test in the CLIA-waived setting is expected to meet at least 95% positive and negative percent agreement with the results obtained from FilmArray RP in the moderate/high- complexity setting for each pathogen on the panel.	1.5 hour	No
Secondary	Epidemiology of respiratory infections in a CLIA-waived setting	Seasonality and rate of respiratory infection at each of the CLIA-waived sites using the FilmArray RP EZ to collect prospectively enrolled specimens will be evaluated at the end of the study.	Up to 9 months	No