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A multi-site observational all-comers study that will be conducted at geographically diverse sites within the United States
Prospectively collected Nasopharyngeal swab specimens will be collected from consented individuals with signs and symptoms of respiratory tract infection at a single timepoint
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasopharyngeal Swab Specimens | Nasopharyngeal Swab specimens from individuals with signs and symptoms of respiratory tract infection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xpert ERP | Diagnostic Test | Detection and Identification of DNA and RNA from multiple bacteria and viruses from nasopharyngeal swabs |
|
| Measure | Description | Time Frame |
|---|---|---|
| Xpert test compared to comparator(s) tests | Evaluating the clinical performance (PPA and NPA) of Xpert ERP relative to comparator(s) | Clinical Performance assessed on specimens collected at Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Specimens collected from individuals with signs and symptoms of respiratory tract infection
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quantigen | Fishers | Indiana | 46037 | United States |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
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Nasopharyngeal Swab specimens collected from consented individuals with sign and symptoms of respiratory tract infection