Validation of the GenePOC Strep A, C/G Assay for Detecting Group A, C and G β-hemolytic Streptococcus From Throat Swabs.
- Conditions
- Pharyngitis, Infective
- Interventions
- Device: Comparison between GenePOC CR and Reference Method
- Registration Number
- NCT03422341
- Lead Sponsor
- Meridian Bioscience, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 497
- 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
• Patient/sample not meeting inclusion criteria above
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GenePOC testing Comparison between GenePOC CR and Reference Method 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. Reference Method 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.
- Primary Outcome Measures
Name Time Method Performance characteristics of the GenePOC Streap A, C/G assay 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
Name Time Method Unresolved sample results 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).
Indeterminate sample results 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).
Positive and Negative Predictive Values (PPV and NPV) 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.
Trial Locations
- Locations (8)
Wishard Health Services
🇺🇸Indianapolis, Indiana, United States
Centre de Recherche Saint-Louis
🇨🇦Québec, Quebec, Canada
BC Children's and Women's Hospital
🇨🇦Vancouver, British Columbia, Canada
Detroit Medical Center University Laboratories
🇺🇸Detroit, Michigan, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Valley Children's Hospital
🇺🇸Madera, California, United States
Mount Sinai Services
🇨🇦Toronto, Ontario, Canada