Detection of Mycoplasma Pneumoniae

Meridian Bioscience

Status: Completed

Conditions: Mycoplasma Pneumoniae

Treatments: Device: illumigene® Mycoplasma Direct, illumipro-10

Study type: Observational

Funder types: Industry

Identifiers

NCT02511262

CLIN-DHF-309-004.001

Details and patient eligibility

About

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.

Enrollment: 471 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

471 participants in 1 patient group

Specimen Collection

Description:

Prospective patients with symptoms of upper respiratory infections which may be attributable to Mycoplasma pneumoniae, or from patients suspected of having Mycoplasma pneumoniae.

Treatment:

Device: illumigene® Mycoplasma Direct, illumipro-10