"Prospective Study for Clinical Validation of the Molecular-Based GenePOC Strep A C/G assay for the Detection and identification of Group A ?-hemolytic Streptococcus (Streptococcus pyogenes) and pyogenic Group C and G ?-hemolytic Streptococcus (Streptococcus dysgalactiae subsp. equisimilis) nucleic acids from throat swab samples obtained from patients with signs and symptoms of pharyngitis. GPC-03-002"
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- STATUS
- Not Recruiting
Summary
The purpose of the clinical investigation is to enroll sufficient samples to obtain a total of 120 samples positive for GAS, and 100-120 samples positive for GCS/GGS, based on the Reference Method final result. With the lowest prevalence of GCS/GGS of 4%, it is projected that up to 3000 samples will be needed. The performance obtained and the confidence interval will be monitored during the study in order to stop the enrollment when appropriate. This study is being conducted to develop a rapid test for the identification of streptococcus which is the leading cause of strep throat.
Description
The purpose of the clinical investigation is to enroll sufficient samples to obtain a total of 120 samples positive for GAS, and 100-120 samples positive for GCS/GGS, based on the Reference Method final result. With the lowest prevalence of GCS/GGS of 4%, it is projected that up to 3000 samples will be needed. The performance obtained and the confidence interval will be monitored during the study in order to stop the enrollment when appropriate. This study is being conducted to develop a rapid test for the identification of streptococcus which is the leading cause of strep throat.
Details
| Condition | Strep |
|---|---|
| Age | 100years or below |
| Clinical Study Identifier | TX8540 |
| Last Modified on | 19 February 2024 |
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