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

Prospective Study for Clinical Validation of the Molecular-Based GenePOC Strep A, C/G Assay for the Detection and Identification of Group A β-hemolytic Streptococcus (Streptococcus Pyogenes) and Pyogenic Group C and G β-hemolytic Streptococcus (Streptococcus Dysgalactiae Subsp. Equisimilis) Nucleic Acids From Throat Swab Samples Obtained From Patients With Signs and Symptoms of Pharyngitis.

The primary purpose of this clinical investigation is to establish the performance of the GenePOC Strep A, C/G assay on the revogene. This will be achieved by comparing the test to a conventional method for detection of Group A β-hemolytic Streptococcus (GAS) and pyogenic Group C and G β-hemolytic Streptococcus (GCS/GGS) in throat swab samples.

Study Overview

• Status: Completed
• Conditions: Pharyngitis, Infective
• Intervention / Treatment: Device: Comparison between GenePOC CR and Reference Method

Detailed Description

The GenePOC Strep A, C/G assay will be performed using the revogene™ instrument. The revogene instrument, used in conjunction with appropriate reagents, is capable of automated cell lysis, dilution of nucleic acids from multiple sample types as well as automated amplification and detection of target nucleic acid sequences.

A dual swab sample is collected when ICF is signed by patient. One of the swab will be tested on the revogene™, and the second swab will be tested with standard microbiology method at a Reference Center.

• Study Type: Interventional
• Enrollment (Actual): 497
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3N1
      • BC Children's and Women's Hospital
  • Ontario
    • Toronto, Ontario, Canada, M5G 1Z5
      • Mount Sinai Services
  • Quebec
    • Québec, Quebec, Canada, G1W 4R4
      • Centre de recherche Saint-Louis
• United States
  • California
    • Madera, California, United States, 93636
      • Valley Children's Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Wishard Health Services
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Detroit Medical Center University Laboratories
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospital
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Samples from patients suspected of having signs and symptoms of a pharyngitis infection
• Patient that signed the approved Informed Consent Form (if applicable)
• Patient older than 2 years of age
• Only one (1) compliant sample per patient is allowed
• Use of dual swab with either liquid Stuart or liquid Amies transport Medium

Exclusion Criteria:

• Patient/sample not meeting inclusion criteria above

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: GenePOC testing; 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; 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.
ACTIVE_COMPARATOR: Reference Method; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive and Negative Predictive Values (PPV and NPV)	To establish the Positive and Negative Predictive Values (PPV and NPV) of the GenePOC Strep A, C/G assay. PPV will be calculated as the proportion of positive results with the GenePOC Strep A, C/G assay that are true positive results when compared to the Reference Method. NPV will be calculated as the proportion of negative results with the GenePOC Strep A, C/G assay that are true negative results when compared to the Reference Method.	Up to 14 months
Unresolved sample results	To establish the rate of unresolved results for the GenePOC Strep A, C/G assay due to sample processing control failure (unresolved sample results).	Up to 14 months
Indeterminate sample results	To establish the rate of indeterminate results for the GenePOC Strep A, C/G assay due to an instrument failure (indeterminate results).	Up to 14 months

Collaborators and Investigators

• Sponsor: Meridian Bioscience, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 14, 2018
• Primary Completion (ACTUAL): July 11, 2018
• Study Completion (ACTUAL): July 11, 2018

Study Registration Dates

• First Submitted: January 23, 2018
• First Submitted That Met QC Criteria: January 29, 2018
• First Posted (ACTUAL): February 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 4, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pharyngitis; Hemolysis
• Other Study ID Numbers: GPC03-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No