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

BioFire Diagnostics

Status: Completed

Conditions: Upper Respiratory Infections

Study type: Observational

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT02232711

HDTRA1-09-C0068 (Other Grant/Funding Number)

SDY-014162

Details and patient eligibility

About

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.

Enrollment: 1,082 patients

Sex: All

Volunteers: No Healthy Volunteers

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