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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Luminex Molecular Diagnostics
ClinicalTrials.gov Identifier:
NCT01787227
First received: February 1, 2013
Last updated: March 1, 2016
Last verified: March 2016
  Purpose

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.


Condition Intervention
Respiratory Tract Infection Bronchitis Bronchiolitis Pneumonia Device: xTAG RPP

Study Type: Observational
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

Further study details as provided by Luminex Molecular Diagnostics:

Primary Outcome Measures:
  • 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
Nasopharyngeal swab

Enrollment: 1500
Study Start Date: January 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Clinical specimens collected from patients with clinical signs and symptoms of respiratory tract infection who are either hospitalized, admitted to emergency departments or visiting outpatient clinics.
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01787227

Locations
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
Canada, Ontario
St. Joseph's Hospital
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
Luminex Molecular Diagnostics
Investigators
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
  More Information

Responsible Party: Luminex Molecular Diagnostics
ClinicalTrials.gov Identifier: NCT01787227     History of Changes
Other Study ID Numbers: TDP-736-272
Study First Received: February 1, 2013
Last Updated: March 1, 2016

Additional relevant MeSH terms:
Infection
Pneumonia
Bronchiolitis
Respiratory Tract Infections
Bronchitis
Lung Diseases
Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases, Obstructive

ClinicalTrials.gov processed this record on August 18, 2017