A Two Arm, Multi-Centre Clinical Evaluation of the NxTAG Respiratory Pathogen Panel
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.
Respiratory Tract Infection
Device: xTAG RPP
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||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|
- Diagnostic accuracy will be expressed in terms of clinical sensitivity and specificity for each claimed target. [ Time Frame: 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.
Biospecimen Retention: Samples With DNA
|Study Start Date:||January 2015|
|Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Blinded, Pre-selected Arm
For targets that exhibit lower prevalence rates in the intended use population, banked, pre-selected, positive clinical specimens will be tested.
|Device: xTAG RPP|
Blinded, Prospective Arm
Diagnostic accuracy for the more prevalent targets will be evaluated in prospectively collected, de-identified, left-over, clinical specimens accrued during the 2012/2013 flu season.
|Device: xTAG RPP|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01787227
|United States, Missouri|
|St. Louis Children's Hospital|
|St. Louis, Missouri, United States|
|United States, New York|
|North Shore‐LIJ Health System Laboratories|
|Lake Success, New York, United States, 11042|
|United States, Texas|
|Scott and White Memorial Hospital|
|Temple, Texas, United States, 76508|
|St. Joseph's Hospital|
|Hamilton, Ontario, Canada, L8N 4A6|
|Study Director:||Jeremy Liu, Ph.D||Luminex Molecular Diagnostics|
|Principal Investigator:||James Mahony, Ph.D, FCCM, FAAM||St. Joseph's Health Care London|
|Principal Investigator:||Richard Buller, PhD, D (ABMM)||St. Louis Children's Hospital|
|Principal Investigator:||Arundhati Rao, M.D., Ph.D.||Scott and White Hospital & Clinic|
|Principal Investigator:||Christine Ginocchio, Ph.D., M.T.(A.S.C.P.)||North Shore‐LIJ Health System Laboratories, NY|