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

• ClinicalTrials.gov Identifier: NCT03422341
• Recruitment Status: Completed
• First Posted: February 5, 2018
• Last Update Posted: May 4, 2021
• Sponsor: Meridian Bioscience, Inc.
• Information provided by (Responsible Party): Meridian Bioscience, Inc.

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Pharyngitis, Infective	Device: Comparison between GenePOC CR and Reference Method	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 497 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: 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.
• Actual Study Start Date: February 14, 2018
• Actual Primary Completion Date: July 11, 2018
• Actual Study Completion Date: July 11, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Performance characteristics of the GenePOC Streap A, C/G assay [ Time Frame: Up to 14 months ]

   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.

Secondary Outcome Measures :

1. Positive and Negative Predictive Values (PPV and NPV) [ Time Frame: Up to 14 months ]

   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.

2. Unresolved sample results [ Time Frame: Up to 14 months ]
   To establish the rate of unresolved results for the GenePOC Strep A, C/G assay due to sample processing control failure (unresolved sample results).
3. Indeterminate sample results [ Time Frame: Up to 14 months ]
   To establish the rate of indeterminate results for the GenePOC Strep A, C/G assay due to an instrument failure (indeterminate results).

Eligibility Criteria

• Ages Eligible for Study: 25 Months and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, California

Valley Children's Hospital

Madera, California, United States, 93636

United States, Indiana

Wishard Health Services

Indianapolis, Indiana, United States, 46202

United States, Michigan

Detroit Medical Center University Laboratories

Detroit, Michigan, United States, 48201

United States, Missouri

Children's Mercy Hospital

Kansas City, Missouri, United States, 64108

United States, Wisconsin

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Canada, British Columbia

BC Children's and Women's Hospital

Vancouver, British Columbia, Canada, V6H 3N1

Canada, Ontario

Mount Sinai Services

Toronto, Ontario, Canada, M5G 1Z5

Canada, Quebec

Centre de Recherche Saint-Louis

Québec, Quebec, Canada, G1W 4R4

Sponsors and Collaborators

Meridian Bioscience, Inc.

Investigators

• Study Director: Patrice Allibert; Meridian Bioscience, Inc.

More Information

• Responsible Party: Meridian Bioscience, Inc.
• ClinicalTrials.gov Identifier: NCT03422341
• Other Study ID Numbers: GPC03-002
• First Posted: February 5, 2018
• Last Update Posted: May 4, 2021
• Last Verified: June 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Pharyngitis; Hemolysis; Pathologic Processes; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases