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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

497 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-14

Study Completion Date

2018-07-11

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pharyngitis, Infective

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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GenePOC testing

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.

Group Type EXPERIMENTAL

Comparison between GenePOC CR and Reference Method

Intervention Type DEVICE

The collected swab will be tested with both the GenePOC Strep A, C/G assay and the Reference Method defined as standard microbiology culture and strain identification using a MALDI TOF.

Reference Method

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.

Group Type ACTIVE_COMPARATOR

Comparison between GenePOC CR and Reference Method

Intervention Type DEVICE

The collected swab will be tested with both the GenePOC Strep A, C/G assay and the Reference Method defined as standard microbiology culture and strain identification using a MALDI TOF.

Interventions

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Comparison between GenePOC CR and Reference Method

The collected swab will be tested with both the GenePOC Strep A, C/G assay and the Reference Method defined as standard microbiology culture and strain identification using a MALDI TOF.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

25 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No