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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01787227
Recruitment Status : Completed
First Posted : February 8, 2013
Last Update Posted : March 3, 2016
Information provided by (Responsible Party):
Luminex Molecular Diagnostics

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.

Condition or disease Intervention/treatment
Respiratory Tract Infection Bronchitis Bronchiolitis Pneumonia Device: xTAG RPP

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Study Type : Observational
Actual Enrollment : 1500 participants
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
Study Start Date : January 2015
Actual Primary Completion Date : September 2015

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

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01787227

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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
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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

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Responsible Party: Luminex Molecular Diagnostics Identifier: NCT01787227    
Other Study ID Numbers: TDP-736-272
First Posted: February 8, 2013    Key Record Dates
Last Update Posted: March 3, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases, Obstructive