Trials Sponsors Conditions Drugs Pricing

Conditions

Pharyngitis, Infective

Outcome Measures

Primary Outcomes (1)

Performance characteristics of the GenePOC Streap A, C/G assay
To establish the performance characteristics of the GenePOC Strep A, C/G assay for its use in determining the presence of Strep A, C/G in throat swab samples obtained from patients with signs and symptoms of pharyngitis infection. * Sensitivity will be estimated as the proportion of positives that are correctly identified by the GenePOC Strep A, C/G assay when compared to the Reference Method. * Specificity will be established as the proportion of negatives that are correctly identified by the GenePOC Strep A, C/G assay when compared to the Reference Method.
Up to 14 months

Secondary Outcomes (3)

Positive and Negative Predictive Values (PPV and NPV)
Up to 14 months
Unresolved sample results
Up to 14 months
Indeterminate sample results
Up to 14 months

Study Arms (2)

GenePOC testing

EXPERIMENTAL

The swab will be used for the testing on the revogene using the GenePOC Strep A, C/G assay. Intervention will be the Comparison between GenePOC CR and Reference Method.

Device: Comparison between GenePOC CR and Reference Method

Reference Method

ACTIVE COMPARATOR

The swab will be used to detect the presence or absence of Strep A, C/G using standard microbiology method. Intervention will be the Comparison between GenePOC CR and Reference Method.

Device: Comparison between GenePOC CR and Reference Method

Interventions

Comparison between GenePOC CR and Reference MethodDevice

The collected swab will be tested with both the GenePOC Strep A, C/G assay and the Reference Method defined as standard microbiology culture and strain identification using a MALDI TOF.

GenePOC testingReference Method

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age25 Months+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Samples from patients suspected of having signs and symptoms of a pharyngitis infection
Patient that signed the approved Informed Consent Form (if applicable)

Sponsors & Collaborators

Meridian Bioscience, Inc.
Industrylead

Study Sites (8)

Valley Children's Hospital

Madera, California, 93636, United States

Wishard Health Services

Indianapolis, Indiana, 46202, United States

Detroit Medical Center University Laboratories

Detroit, Michigan, 48201, United States

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

BC Children's and Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Mount Sinai Services

Toronto, Ontario, M5G 1Z5, Canada

MeSH Terms

Conditions

Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

Patrice Allibert
Meridian Bioscience, Inc.
STUDY DIRECTOR

Enrollment

497 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: DIAGNOSTIC
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 23, 2018

First Posted

February 5, 2018

Study Start

February 14, 2018

Actual (reported)

Validation of the GenePOC Strep A, C/G Assay for Detecting Group A, C and G β-hemolytic Streptococcus From Throat Swabs.

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

GenePOC testing

Reference Method

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (8)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

GenePOC testing

Reference Method

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (8)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations