ClinicalTrials.gov record
Completed Not applicable Interventional

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

ClinicalTrials.gov ID: NCT03422341

Public ClinicalTrials.gov record NCT03422341. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 10, 2026, 11:26 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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.

Study identification

NCT ID
NCT03422341
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Meridian Bioscience, Inc.
Industry
Enrollment
497 participants

Conditions and interventions

Interventions

  • Comparison between GenePOC CR and Reference Method Device

Device

Eligibility (public fields only)

Age range
25 Months and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 13, 2018
Primary completion
Jul 10, 2018
Completion
Jul 10, 2018
Last update posted
May 3, 2021

2018

United States locations

U.S. sites
5
U.S. states
5
U.S. cities
5
Facility City State ZIP Site status
Valley Children's Hospital Madera California 93636
Wishard Health Services Indianapolis Indiana 46202
Detroit Medical Center University Laboratories Detroit Michigan 48201
Children's Mercy Hospital Kansas City Missouri 64108
Medical College of Wisconsin Milwaukee Wisconsin 53226

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03422341, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 3, 2021 · Synced May 10, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03422341 live on ClinicalTrials.gov.

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