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

Completed · Not applicable

Conditions studied: Pharyngitis, Infective

In brief

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.

Key facts

Study ID

NCT03422341

Run by

Meridian Bioscience, Inc.

People needed

497

Starts

2018-02-14

Expected to finish

2018-07-11

Last updated by the study team

2021-05-04

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Patient/sample not meeting inclusion criteria above

Where it is running

• Valley Children's Hospital — Madera, California, United States
• Wishard Health Services — Indianapolis, Indiana, United States
• Detroit Medical Center University Laboratories — Detroit, Michigan, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• BC Children's and Women's Hospital — Vancouver, British Columbia, Canada
• Mount Sinai Services — Toronto, Ontario, Canada
• Centre de Recherche Saint-Louis — Québec, Quebec, Canada

Full record on ClinicalTrials.gov

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