NCT03422341

Validation of the GenePOC Strep A, C/G Assay for Detecting Group A, C and G β-hemolytic Streptococcus From Throat Swabs.

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 497 (actual)
• Sponsor: Meridian Bioscience, Inc. · Industry
• Sex: All
• Age: 25 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Pharyngitis, Infective

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-02-14
• Primary completion: 2018-07-11
• Completion: 2018-07-11
• First posted: 2018-02-05
• Last updated: 2021-05-04

Locations

8 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study