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

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