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

L

Luminex

Status

Completed

Conditions

Respiratory Tract Infection
Bronchiolitis
Bronchitis
Pneumonia

Treatments

Device: xTAG RPP

Study type

Observational

Funder types

Industry

Identifiers

NCT01787227
TDP-736-272

Details and patient eligibility

About

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.

Enrollment

1,500 patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

1,500 participants in 2 patient groups

Blinded, Pre-selected Arm
Description:
For targets that exhibit lower prevalence rates in the intended use population, banked, pre-selected, positive clinical specimens will be tested.
Treatment:
Device: xTAG RPP
Blinded, Prospective Arm
Description:
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.
Treatment:
Device: xTAG RPP

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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