Detection of Mycoplasma Pneumoniae

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.

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.