Validation of the GenePOC Strep A, C/G Assay for Detecting Group A, C and G β-hemolytic Streptococcus From Throat Swabs.
Study Details
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 |
|---|---|---|
|
N/A |
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
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
- 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
- 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.
- 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).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Samples from patients suspected of having signs and symptoms of a pharyngitis infection
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Patient that signed the approved Informed Consent Form (if applicable)
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Patient older than 2 years of age
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Only one (1) compliant sample per patient is allowed
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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
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Valley Children's Hospital | Madera | California | United States | 93636 |
| 2 | Wishard Health Services | Indianapolis | Indiana | United States | 46202 |
| 3 | Detroit Medical Center University Laboratories | Detroit | Michigan | United States | 48201 |
| 4 | Children's Mercy Hospital | Kansas City | Missouri | United States | 64108 |
| 5 | Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
| 6 | BC Children's and Women's Hospital | Vancouver | British Columbia | Canada | V6H 3N1 |
| 7 | Mount Sinai Services | Toronto | Ontario | Canada | M5G 1Z5 |
| 8 | Centre de Recherche Saint-Louis | Québec | Quebec | Canada | G1W 4R4 |
Sponsors and Collaborators
- Meridian Bioscience, Inc.
Investigators
- Study Director: Patrice Allibert, Meridian Bioscience, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GPC03-002