This study is currently not recruiting participants.

"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"

Investigation of a Rapid Test for Streptococcus Identification (a type of bacteria)

Not Recruiting
100 years or below
All
Phase N/A

Brief description of study.

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.

Detailed description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Strep
  • Age: 100 years or below
  • Gender: All

This study investigates a rapid test for identifying streptococcus, a bacteria that causes strep throat. Streptococcus can be divided into groups such as GAS (Group A Streptococcus) and GCS/GGS (Group C and Group G Streptococcus). The study aims to collect enough samples to confirm the presence of these bacteria.

The study involves collecting samples to test for GAS and GCS/GGS using a reference method. The goal is to gather 120 samples positive for GAS and between 100-120 samples positive for GCS/GGS. The study will continue until enough samples are collected to meet these targets.

  • Who can participate: The study is open to individuals aged 18 and older who have symptoms of strep throat. Participants should not have used antibiotics in the past two weeks.
  • Study details: Participants will provide throat swabs for testing. The swabs will be analyzed using the investigational rapid test as well as a reference method.
Updated on 19 Feb 2024. Study ID: 1801645755

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