Pharyngitis, Infective Clinical Trial
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.
| Verified date | June 2019 |
| Source | Meridian Bioscience, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 497 |
| Est. completion date | July 11, 2018 |
| Est. primary completion date | July 11, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 25 Months and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Centre de Recherche Saint-Louis | Québec | Quebec |
| Canada | Mount Sinai Services | Toronto | Ontario |
| Canada | BC Children's and Women's Hospital | Vancouver | British Columbia |
| United States | Detroit Medical Center University Laboratories | Detroit | Michigan |
| United States | Wishard Health Services | Indianapolis | Indiana |
| United States | Children's Mercy Hospital | Kansas City | Missouri |
| United States | Valley Children's Hospital | Madera | California |
| United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
| Lead Sponsor | Collaborator |
|---|---|
| Meridian Bioscience, Inc. |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 |