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



Status:Completed
Conditions:Bronchitis, Pneumonia, Infectious Disease, Pulmonary
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:January 2015

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A Two Arm, Multi-Centre Clinical Evaluation of the NxTAG Respiratory Pathogen Panel (NxTAG RPP) in Patients With Clinical Signs and Symptoms of Respiratory Tract Infection

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.


Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.
We found this trial at
4
sites
2401 S. 31st Street
Temple, Texas 76508
254-724-2111
Scott & White Memorial Hospital When Arthur C. Scott, MD, and Raleigh R. White Jr.,...
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Hamilton, Ontario
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Hamilton,
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Lake Success, New York 11042
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Lake Success, NY
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St. Louis, Missouri 63108
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St. Louis, MO
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