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

Meridian Bioscience, Inc.497 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

497

Conditions

Pharyngitis, Infective

Interventions

Comparison between GenePOC CR and Reference MethodDEVICE

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.

Eligibility

Sex: ALLMin age: 25 Months

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Performance characteristics of the GenePOC Streap A, C/G assay

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.

Time frame: Up to 14 months

Secondary Outcomes

Positive and Negative Predictive Values (PPV and NPV)

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.

Time frame: Up to 14 months

Unresolved sample results

To establish the rate of unresolved results for the GenePOC Strep A, C/G assay due to sample processing control failure (unresolved sample results).

Time frame: Up to 14 months

Indeterminate sample results

To establish the rate of indeterminate results for the GenePOC Strep A, C/G assay due to an instrument failure (indeterminate results).

Time frame: Up to 14 months

Data from ClinicalTrials.gov

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