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

Not Applicable

Completed

• Conditions: Pharyngitis, Infective

• Registration Number: NCT03422341
• Lead Sponsor: Meridian Bioscience, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2018-01-23
• Study First Submitted QC: 2018-01-29
• Study First Posted: 2018-02-05
• Study Start: 2018-02-14
• Primary Completion: 2018-07-11
• Study Completion: 2018-07-11
• Status Verified: 2019-06
• Last Update Submitted: 2021-04-29
• Last Update Posted: 2021-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 497

Inclusion Criteria

• 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

Exclusion Criteria

• Patient/sample not meeting inclusion criteria above

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Performance characteristics of the GenePOC Streap A, C/G assay	Up to 14 months	To establish the performance characteristics of the GenePOC Strep A, C/G assay for its use in determining the presence of Strep A, C/G in throat swab samples obtained from patients with signs and symptoms of pharyngitis infection.; * Sensitivity will be estimated as the proportion of positives that are correctly identified by the GenePOC Strep A, C/G assay when compared to the Reference Method.; * Specificity will be established as the proportion of negatives that are correctly identified by the GenePOC Strep A, C/G assay when compared to the Reference Method.

Secondary Outcome Measures

Name	Time	Method
Unresolved sample results	Up to 14 months	To establish the rate of unresolved results for the GenePOC Strep A, C/G assay due to sample processing control failure (unresolved sample results).
Indeterminate sample results	Up to 14 months	To establish the rate of indeterminate results for the GenePOC Strep A, C/G assay due to an instrument failure (indeterminate results).
Positive and Negative Predictive Values (PPV and NPV)	Up to 14 months	To establish the Positive and Negative Predictive Values (PPV and NPV) of the GenePOC Strep A, C/G assay.; PPV will be calculated as the proportion of positive results with the GenePOC Strep A, C/G assay that are true positive results when compared to the Reference Method.; NPV will be calculated as the proportion of negative results with the GenePOC Strep A, C/G assay that are true negative results when compared to the Reference Method.

Trial Locations

Locations (8)

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