Validation of the GenePOC Strep A, C/G Assay for Detecting Group A, C and G β-hemolytic Streptococcus From Throat Swabs.
Primary Purpose
Pharyngitis, Infective
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Comparison between GenePOC CR and Reference Method
Sponsored by
About this trial
This is an interventional diagnostic trial for Pharyngitis, Infective
Eligibility 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
Sites / Locations
- Valley Children's Hospital
- Wishard Health Services
- Detroit Medical Center University Laboratories
- Children's Mercy Hospital
- Medical College of Wisconsin
- BC Children's and Women's Hospital
- Mount Sinai Services
- Centre de Recherche Saint-Louis
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
GenePOC testing
Reference Method
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
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).
Full Information
NCT ID
NCT03422341
First Posted
January 23, 2018
Last Updated
April 29, 2021
Sponsor
Meridian Bioscience, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03422341
Brief Title
Validation of the GenePOC Strep A, C/G Assay for Detecting Group A, C and G β-hemolytic Streptococcus From Throat Swabs.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
February 14, 2018 (Actual)
Primary Completion Date
July 11, 2018 (Actual)
Study Completion Date
July 11, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meridian Bioscience, Inc.
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pharyngitis, Infective
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
497 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GenePOC testing
Arm Type
Experimental
Arm Description
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.
Arm Title
Reference Method
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Comparison between GenePOC CR and Reference Method
Intervention Description
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.
Primary Outcome Measure Information:
Title
Performance characteristics of the GenePOC Streap A, C/G assay
Description
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.
Time Frame
Up to 14 months
Secondary Outcome Measure Information:
Title
Positive and Negative Predictive Values (PPV and NPV)
Description
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.
Time Frame
Up to 14 months
Title
Unresolved sample results
Description
To establish the rate of unresolved results for the GenePOC Strep A, C/G assay due to sample processing control failure (unresolved sample results).
Time Frame
Up to 14 months
Title
Indeterminate sample results
Description
To establish the rate of indeterminate results for the GenePOC Strep A, C/G assay due to an instrument failure (indeterminate results).
Time Frame
Up to 14 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrice Allibert
Organizational Affiliation
Meridian Bioscience, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Valley Children's Hospital
City
Madera
State/Province
California
ZIP/Postal Code
93636
Country
United States
Facility Name
Wishard Health Services
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Detroit Medical Center University Laboratories
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
BC Children's and Women's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3N1
Country
Canada
Facility Name
Mount Sinai Services
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1Z5
Country
Canada
Facility Name
Centre de Recherche Saint-Louis
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Validation of the GenePOC Strep A, C/G Assay for Detecting Group A, C and G β-hemolytic Streptococcus From Throat Swabs.
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