Implementation Assessment and Clinical Utility of the FilmArray® Respiratory Panel (RP) EZ in a CLIA-waived Setting
| Status: | Completed |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any - 100 |
| Updated: | 9/27/2017 |
| Start Date: | April 4, 2017 |
| End Date: | September 15, 2017 |
BioFire Diagnostics, LLC (BioFire; a bioMerieux company), has developed a multiplexed
molecular-based in vitro diagnostic platform for infectious disease testing known as the
FilmArray. The FilmArray Respiratory Panel (RP) EZ is a test designed for use with the
FilmArray 2.0 EZ Configuration instrument that identifies common bacterial and viral
microorganisms associated with respiratory tract infections from a nasopharyngeal swab (NPS)
specimen collected in viral transport media (VTM). The RP EZ was granted CLIA-waived
classification by the FDA in October 2016 and is the first highly-multiplexed molecular test
to receive this designation.
The purpose of this study is to measure patient outcomes following implementation of the RP
EZ test and to also gather data about physician office workflow and user interactions with
the device. These data will be used to understand how the adoption of such tests may
influence patient care in the CLIA-waived setting.
molecular-based in vitro diagnostic platform for infectious disease testing known as the
FilmArray. The FilmArray Respiratory Panel (RP) EZ is a test designed for use with the
FilmArray 2.0 EZ Configuration instrument that identifies common bacterial and viral
microorganisms associated with respiratory tract infections from a nasopharyngeal swab (NPS)
specimen collected in viral transport media (VTM). The RP EZ was granted CLIA-waived
classification by the FDA in October 2016 and is the first highly-multiplexed molecular test
to receive this designation.
The purpose of this study is to measure patient outcomes following implementation of the RP
EZ test and to also gather data about physician office workflow and user interactions with
the device. These data will be used to understand how the adoption of such tests may
influence patient care in the CLIA-waived setting.
The FilmArray RP EZ may offer improvements over conventional CLIA-waived testing for
respiratory infections. Molecular-based testing provides increased sensitivity and
specificity relative to current clinical reference methods and multiplexed panels offer a
greater breadth of organism identification and diagnostic yield than is available using
standard methods available in the CLIA-waived setting. Because of these attributes, the
results from this test have the potential to enable clinicians to more accurately diagnose
and treat respiratory illness.
It is hypothesized that the sensitive, specific, and comprehensive results provided by
FilmArray RP EZ will allow clinicians to more rapidly diagnose respiratory illness and
implement appropriate therapy, as well as provide subjects with appropriate expectations
about their course of illness.
This interventional clinical trial that will be initiated during the 2016-2017 respiratory
illness season to measure the utility of FilmArray RP EZ when implemented in an outpatient
care setting. At least three different outpatient or urgent care clinics within the UCLA
Health system will be selected for participation. Subjects will be randomized into two groups
within each site. The control group will receive standard of care according to the subject's
provider's determination. The intervention group will receive testing with FilmArray RP EZ.
Outcome measures will include (but are not limited to) total healthcare costs, antimicrobial
prescription rates, timeliness, and appropriateness of therapy, clinician attitudes towards
laboratory test capabilities, and subject satisfaction with their healthcare encounter.
As specimens will be collected specifically for this research study, written informed
consent, assent, and/or parental permission will be obtained from all study participants.
respiratory infections. Molecular-based testing provides increased sensitivity and
specificity relative to current clinical reference methods and multiplexed panels offer a
greater breadth of organism identification and diagnostic yield than is available using
standard methods available in the CLIA-waived setting. Because of these attributes, the
results from this test have the potential to enable clinicians to more accurately diagnose
and treat respiratory illness.
It is hypothesized that the sensitive, specific, and comprehensive results provided by
FilmArray RP EZ will allow clinicians to more rapidly diagnose respiratory illness and
implement appropriate therapy, as well as provide subjects with appropriate expectations
about their course of illness.
This interventional clinical trial that will be initiated during the 2016-2017 respiratory
illness season to measure the utility of FilmArray RP EZ when implemented in an outpatient
care setting. At least three different outpatient or urgent care clinics within the UCLA
Health system will be selected for participation. Subjects will be randomized into two groups
within each site. The control group will receive standard of care according to the subject's
provider's determination. The intervention group will receive testing with FilmArray RP EZ.
Outcome measures will include (but are not limited to) total healthcare costs, antimicrobial
prescription rates, timeliness, and appropriateness of therapy, clinician attitudes towards
laboratory test capabilities, and subject satisfaction with their healthcare encounter.
As specimens will be collected specifically for this research study, written informed
consent, assent, and/or parental permission will be obtained from all study participants.
Inclusion Criteria:
- Subject presents with signs/symptoms of respiratory infection including but not
limited to fever, cough, sore throat, runny nose, myalgia, headache, chills, or
fatigue.
- Subject provides written informed consent/assent/parental permission
- Willing and able to provide NPS specimen
Exclusion Criteria:
- Subject is unable to provide consent/assent/parental permission
- Children whose legal guardian is not available to give permission
- Unable/unwilling to provide NPS specimen
- Non-English speaking
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