A Two Arm, Multi-Centre Clinical Evaluation of the NxTAG Respiratory Pathogen Panel

Completed

Conditions studied: Respiratory Tract Infection, Bronchitis, Bronchiolitis, Pneumonia

In brief

xTAG RPP assay is a PCR-based assay to detect the presence or absence of viral and bacterial DNA / RNA in clinical specimens (nasopharyngeal swabs). The objective of this study is to establish diagnostic accuracy of the xTAG RPP.

Key facts

Study ID

NCT01787227

Run by

Luminex Molecular Diagnostics

People needed

1500

Starts

2015-01-01

Last updated by the study team

2016-03-03

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The specimen is a nasopharyngeal swab.
• The specimen is from a pediatric or adult, male or female subject who is either hospitalized, admitted to a hospital emergency department, visiting an outpatient clinic or resident of a long-term care facility.
• The specimen is from a patient exhibiting clinical signs and symptoms of respiratory tract infection such as fever, sore throat, shortness of breath, bronchitis, bronchiolitis and pneumonia.

You may not qualify if…

• The specimen is not a nasopharyngeal swab.
• The specimen is from an individual who does not exhibit clinical signs and symptoms of respiratory tract infection.

Where it is running

• St. Louis Children's Hospital — St Louis, Missouri, United States
• North Shore-LIJ Health System Laboratories — Lake Success, New York, United States
• Scott and White Memorial Hospital — Temple, Texas, United States
• St. Joseph's Hospital — Hamilton, Ontario, Canada

Full record on ClinicalTrials.gov

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