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 |
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.
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
Scott & White Memorial Hospital When Arthur C. Scott, MD, and Raleigh R. White Jr.,...
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