Detection of Mycoplasma Pneumoniae

Meridian Bioscience, Inc.471 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

471

Conditions

Mycoplasma Pneumoniae

Interventions

illumigene® Mycoplasma Direct, illumipro-10DEVICE

DNA amplification assay

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (3)

Sacred Heart Health System

Pensacola, Florida, United States

The Children's Mercy Hospital

Kansas City, Missouri, United States

Cook Children's Healthcare System (CCHCS)

Fort Worth, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: Up to 14 days

Data from ClinicalTrials.gov

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