Clinical trial NCT03422341: Validation of the GenePOC Strep A, C/G Assay for Detecting Group A, C and G β-hemolytic Streptococcus From Throat Swabs.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pharyngitis, Infective
Lead sponsor: Meridian Bioscience, Inc.
Sponsor class: INDUSTRY
First posted: 2018-02-05
Enrollment: 497
Sex: ALL
Minimum age (years): 25
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Performance characteristics of the GenePOC Streap A, C/G assay
timeFrame: Up to 14 months
Secondary outcomes:
measure: Positive and Negative Predictive Values (PPV and NPV)
timeFrame: Up to 14 months
measure: Unresolved sample results
timeFrame: Up to 14 months
measure: Indeterminate sample results
timeFrame: Up to 14 months
Other outcomes:
Locations:
city: Madera
country: United States
facility: Valley Children's Hospital
state: California
city: Indianapolis
country: United States
facility: Wishard Health Services
state: Indiana
city: Detroit
country: United States
facility: Detroit Medical Center University Laboratories
state: Michigan
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Vancouver
country: Canada
facility: BC Children's and Women's Hospital
state: British Columbia
city: Toronto
country: Canada
facility: Mount Sinai Services
state: Ontario
city: Québec
country: Canada
facility: Centre de Recherche Saint-Louis
state: Quebec
Study officials:
affiliation: Meridian Bioscience, Inc.
name: Patrice Allibert
role: STUDY_DIRECTOR
References: