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

March 1, 2016 updated by: Luminex Molecular Diagnostics

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Hospital
  • United States
    • Missouri
      • St. Louis, Missouri, United States
        • St. Louis Children's Hospital
    • New York
      • Lake Success, New York, United States, 11042
        • North Shore-LIJ Health System Laboratories
    • Texas
      • Temple, Texas, United States, 76508
        • Scott and White Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within the first year after sample extraction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

February 1, 2013

First Submitted That Met QC Criteria

February 6, 2013

First Posted (Estimate)

February 8, 2013

Study Record Updates

Last Update Posted (Estimate)

March 3, 2016

Last Update Submitted That Met QC Criteria

March 1, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TDP-736-272

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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