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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

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (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.

Study Sites (6)

Indiana University Health

Indianapolis, Indiana, 46202, United States

St. John Hospital and Medical Center

Grosse Pointe Woods, Michigan, 48230, United States

Tricore

Albuquerque, New Mexico, 87102, United States

Nationwide Children's Hospital Laboratory

Columbus, Ohio, 43205, United States

Marshfield Labs

Marshfield, Wisconsin, 54449, United States

Luminex Molecular Diagnostics

Toronto, Ontario, M5G 1Y8, Canada

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

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.

Sponsor Type

INDUSTRY

Responsible Party

SPONSOR

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (3)

Blinded, Prospective Arm (1)

Blinded, Pre-selected Arm (2)

Blinded, Contrived Arm (3)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (3)

Blinded, Prospective Arm (1)

Blinded, Pre-selected Arm (2)

Blinded, Contrived Arm (3)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations