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

Meridian Bioscience

Status: Completed

Conditions: Pharyngitis, Infective

Treatments: Device: Comparison between GenePOC CR and Reference Method

Study type: Interventional

Funder types: Industry

Identifiers

NCT03422341

GPC03-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 497 patients

Sex: All

Ages: 25+ months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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497 participants in 2 patient groups

GenePOC testing

Experimental group

Description:

The swab will be used for the testing on the revogene using the GenePOC Strep A, C/G assay. Intervention will be the Comparison between GenePOC CR and Reference Method.

Treatment:

Device: Comparison between GenePOC CR and Reference Method

Reference Method

Active Comparator group

Description:

The swab will be used to detect the presence or absence of Strep A, C/G using standard microbiology method. Intervention will be the Comparison between GenePOC CR and Reference Method.

Treatment:

Device: Comparison between GenePOC CR and Reference Method