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

NCT02862262 | Completed FDA Device

• 1 other identifier: LMA-BRD-01-CS-001
• Study Type: interventional
• Target: 1,052
• Locations: 2 countries
• Sites: 6

Brief Summary

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.

Conditions

Bordetella Infections; Bordetella Pertussis Infection; Bordetella Parapertussis Infection

Outcome Measures

Primary Outcomes (1)

• Specificity and sensitivity of the ARIES Bordetella Assay in patients suspected of having respiratory infection attributable to B. pertussis or B. parapertussis.

  Estimates of positive percent agreement and negative percent agreement for each target will be calculated based on a two-by-two table (reference method result vs. result from ARIES Bordetella Assay) for each target. In addition, 95% two sided confidence intervals will be provided. Positive agreement and negative agreement values will be provided for the entire prospective data set.

  5 months

Secondary Outcomes (3)

• Clinical performance of the ARIES Bordetella Assay per clinical site.

  5 months

• Clinical performance of the ARIES Bordetella Assay per age group.

  5 months

• Clinical performance of the ARIES Bordetella Assay per patient sub-population.

  5 months

Study Arms (3)

Blinded, Prospective Arm (1)

EXPERIMENTAL

Clinical performance of the ARIES Bordetella Assay for the detection of B. pertussis and B. parapertussis will be evaluated in prospectively collected, de-identified, left-over, clinical specimens.

Device: ARIES Bordetella Assay

Blinded, Pre-selected Arm (2)

EXPERIMENTAL

In the event that an insufficient number of positive specimens are acquired for B. pertussis / B. parapertussis in Arm 1, clinical performance of the ARIES Bordetella Assay will be tested using banked, pre-selected, positive clinical specimens.

Device: ARIES Bordetella Assay

Blinded, Contrived Arm (3)

EXPERIMENTAL

Contrived specimens will be tested using the ARIES Bordetella Assay to evaluate detection of B. parapertussis in the event that an insufficient number of positive specimens are acquired in Arm 2.

Device: ARIES Bordetella Assay

Interventions

ARIES Bordetella Assay DEVICE

Blinded, Contrived Arm (3); Blinded, Pre-selected Arm (2); Blinded, Prospective Arm (1)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Luminex Molecular Diagnostics: lead

Study Sites (6)

Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

St. John Hospital and Medical Center

Grosse Pointe Woods, Michigan, 48230, United States

Location

Tricore

Albuquerque, New Mexico, 87102, United States

Location

Nationwide Children's Hospital Laboratory

Columbus, Ohio, 43205, United States

Location

Marshfield Labs

Marshfield, Wisconsin, 54449, United States

Location

Luminex Molecular Diagnostics

Toronto, Ontario, M5G 1Y8, Canada

Location

Related Publications (1)

• Relich RF, Leber A, Young S, Schutzbank T, Dunn R, Farhang J, Uphoff TS. Multicenter Clinical Evaluation of the Automated Aries Bordetella Assay. J Clin Microbiol. 2019 Jan 30;57(2):e01471-18. doi: 10.1128/JCM.01471-18. Print 2019 Feb.

  PMID: 30518543 DERIVED

MeSH Terms

Conditions

Bordetella Infections; Whooping Cough

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Ronald Dunn

  Luminex Molecular Diagnostics

  STUDY DIRECTOR

• Timothy S Uphoff, PhD

  Marshfield Labs

  PRINCIPAL INVESTIGATOR

• Stephen Young, PhD

  Tricore Reference Lab

  PRINCIPAL INVESTIGATOR

• Ryan Relich, PhD

  IU Health Pathology Laboratory

  PRINCIPAL INVESTIGATOR

• Ted E Schutzbank, PhD

  St. John Hospital & Medical Center

  PRINCIPAL INVESTIGATOR

• Amy L Leber, PhD

  Nationwide Children's Hospital Laboratory

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: All eligible specimens (de-identified remnants) enrolled are tested using both the investigational device as well as the reference method.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is comprised of three arms: Arm 1: Blinded, Prospective Arm Primary arm comprised of prospectively collected, de-identified, left-over nasopharyngeal swab specimens. Arm 2: Blinded, Pre-selected Arm Because both B. pertussis and B. parapertussis exhibited low prevalence rates in the prospective study cohort, the prospective sample set was supplemented with banked (pre-selected) positive specimens collected at selected sites. Arm 3: Contrived Specimens Because the number of B. parapertussis positive clinical specimens tested in Arm 1 and Arm 2 of the study was insufficient for accurate estimate of positive percent agreement (PPA) for this target, fifty (50) contrived specimens spiked with relevant B. parapertussis strains at different levels were also prepared. The analyte concentrations covered clinically relevant titers.

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: August 11, 2016
• Study Start: July 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 14, 2016
• Last Updated: October 4, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (5); CA (1)