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| ID | Type | Description | Link |
|---|---|---|---|
| HDTRA1-09-C0068 | Other Grant/Funding Number | Defense Threat Reduction Agency |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals with signs and/or symptoms of respiratory infections
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Health Research Center | San Diego | California | 92152 | United States | ||
| Barnes-Jewish/Washington University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10921934 | Background | 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. | |
| 23931834 | Background | Buller RS. Molecular detection of respiratory viruses. Clin Lab Med. 2013 Sep;33(3):439-60. doi: 10.1016/j.cll.2013.03.007. |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D000095384 | Pathologic Complete Response |
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D018450 | Disease Progression |
| D020969 | Disease Attributes |
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Nasopharyngeal swab (NPS) specimens
| St Louis |
| Missouri |
| 63103 |
| United States |
| UTMB Primary Care Pavilion | Galveston | Texas | 77550 | United States |
| South Main Clinic | Salt Lake City | Utah | 84115 | United States |
| 24267186 | Background | 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. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |