A Multi-Site Clinical Evaluation of the ARIES Bordetella Assay in Symptomatic Patients

Completed · Not applicable

Conditions studied: Bordetella Infections, Bordetella Pertussis Infection, Bordetella Parapertussis Infection

In brief

A three-arm, multi-site clinical evaluation of the ARIES Bordetella Assay for the detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acids in prospectively collected, de-identified, left-over clinical specimens; banked, pre-selected clinical specimens; and contrived specimens.

Key facts

Study ID

NCT02862262

Run by

Luminex Molecular Diagnostics

People needed

1052

Starts

2016-07-01

Expected to finish

2016-11-14

Last updated by the study team

2018-10-04

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The specimen is a nasopharyngeal swab collected using a cleared nasopharyngeal swab and transport medium.
• The specimen is from an adult or pediatric, male or female subject who is either hospitalized, admitted to a hospital emergency department, visiting an outpatient clinica or resident of a long term care facility.
• The specimen is from a patient for whom a requisition has been made for B. pertussis and/or B. parapertussis testing.
• The specimen is from a patient exhibiting clinical signs and symptoms of respiratory tract infection consistent with B. pertussis or B. parapertussis.
• The specimen was received in good condition (no leakage or drying of the specimen).
• The specimen contains a minimum volume of 1000 μL.

You may not qualify if…

• The specimen is not a nasopharyngeal swab collected using a cleared nasopharyngeal swab and transport medium.
• The specimen was not properly collected, transported, processed or stored according to the instructions provided by the Sponsor in Section 10 below.
• The specimen volume is <1000 μL.
• Any specimen that was not tested per the complete testing algorithm provided by the Sponsor.

Where it is running

• Indiana University Health — Indianapolis, Indiana, United States
• St. John Hospital and Medical Center — Grosse Pointe Woods, Michigan, United States
• Tricore — Albuquerque, New Mexico, United States
• Nationwide Children's Hospital Laboratory — Columbus, Ohio, United States
• Marshfield Labs — Marshfield, Wisconsin, United States
• Luminex Molecular Diagnostics — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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