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Completed

NCT Number: NCT01787227

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.

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Key information

Conditions

Respiratory Tract Infection Bronchial Diseases Bronchiolitis Bronchitis Infections Lung Diseases Lung Diseases, Obstructive Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Joseph's Hospital, Hamilton, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

xTAG RPP

Device

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Luminex Molecular Diagnostics

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
First posted
Feb 8, 2013
Registry last updated
Mar 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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