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The objective of this Clinical Trial is to define the methods to be used to document that illumigene® Mycoplasma Direct meets its intended use claims, using the illumipro instrument, with throat swab samples collected from symptomatic patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Specimen Collection | Prospective patients with symptoms of upper respiratory infections which may be attributable to Mycoplasma pneumoniae, or from patients suspected of having Mycoplasma pneumoniae. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| illumigene® Mycoplasma Direct, illumipro-10 | Device | DNA amplification assay |
|
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative detection of Mycoplasma Pneumoniae to aid in the diagnosis of M. pneumoniae infections. | Testing of each enrolled subject's samples will be performed within 14 days of collection. | Up to 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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Prospective patients with symptoms of upper respiratory infections which may be attributable to Mycoplasma pneumoniae, or from patients suspected of having Mycoplasma pneumoniae.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sacred Heart Health System | Pensacola | Florida | 32513 | United States | ||
| The Children's Mercy Hospital |
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Dual throat swabs.
| Kansas City |
| Missouri |
| 64108 |
| United States |
| Cook Children's Healthcare System (CCHCS) | Fort Worth | Texas | 76104-2796 | United States |