Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A multi-center evaluation to assess the diagnostic sensitivity and specificity of the ARIES Group A Strep Assay will be established through a method comparison using prospectively collected, de-identified, clinical samples collected during the enrollment period.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A Strep Assay |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARIES Group A Strep Assay | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical performance (sensitivity/specificity) for Group A Strep Assay | Day 1 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Patients presenting with signs and symptoms of pharyngitis for which their doctors ordered a Group A Strep test.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ronald Dunn | Luminex Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States | ||
| Sacred Heart Hospital |
Not provided
Not provided
Not provided
Not provided
| Pensacola |
| Florida |
| 32504 |
| United States |
| Children's Mercy Hospital | Kansas City | Missouri | 54449 | United States |
| Advanced Pediatrics Research | Vienna | Virginia | 22180 | United States |
| Marshfield Labs | Marshfield | Wisconsin | 54449 | United States |