Detection of Mycoplasma Pneumoniae
| Status: | Completed |
|---|---|
| Conditions: | Pneumonia |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | August 2015 |
Clinical Trial Protocol for the Illumigene® Mycoplasma Direct Assay
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.
illumigene® Mycoplasma Direct meets its intended use claims, using the illumipro instrument,
with throat swab samples collected from symptomatic patients.
Inclusion Criteria:
- The subject has willingly given written informed consent.
- Specimens provided from subjects with symptoms of upper respiratory infections which
may be attributable to Mycoplasma pneumoniae, or from patients suspected of having
Mycoplasma pneumoniae.
- Dual throat swab collected per subject.
Exclusion Criteria:
- Subjects who are unwilling to sign the written informed consent.
- Multiple sets of specimens collected from the same subject.
- Subjects who are unwilling or unable to provide the required number of throat swabs.
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