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

NCT ID: NCT02232711

Last Updated: 2015-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1082 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Upper Respiratory Infections

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

BioFire Diagnostics, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Naval Health Research Center

San Diego, California, United States

Site Status

Barnes-Jewish/Washington University School of Medicine

St Louis, Missouri, United States

Site Status

UTMB Primary Care Pavilion

Galveston, Texas, United States

Site Status

South Main Clinic

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 10921934 (View on PubMed)

Buller RS. Molecular detection of respiratory viruses. Clin Lab Med. 2013 Sep;33(3):439-60. doi: 10.1016/j.cll.2013.03.007.

Reference Type BACKGROUND
PMID: 23931834 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24267186 (View on PubMed)

Other Identifiers

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HDTRA1-09-C0068

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SDY-014162

Identifier Type: -

Identifier Source: org_study_id

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