Evaluation of Accuracy and Ease of Use of the FilmArray™ Respiratory Panel (RP EZ) in a CLIA-Waived Clinical Setting
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Pulmonary |
| Therapuetic Areas: | Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2014 |
| End Date: | July 2015 |
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.
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.
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
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