Bronchiolitis, Bronchitis, Pneumonia, Respiratory Tract Infection
Conditions
Brief summary
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.
Interventions
DEVICExTAG RPP
Sponsors
Luminex Molecular Diagnostics
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy will be expressed in terms of clinical sensitivity and specificity for each claimed target. | Within the first year after sample extraction | Accuracy determinations (diagnostic sensitivity and specificity, positive and negative agreement) were based on the fraction of comparator positive (or negative) results which were also positive (or negative) by xTAG RPP. |
Countries
Canada, United States
Outcome results
None listed