Validation of the GenePOC Strep A, C/G Assay for Detecting Group A, C and G β-hemolytic Streptococcus From Throat Swabs.
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Other Indications, Hematology |
| Therapuetic Areas: | Hematology, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/20/2018 |
| Start Date: | February 14, 2018 |
| End Date: | April 30, 2019 |
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.
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.
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.
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.
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
We found this trial at
6
sites
4201 Saint Antoine Street
Detroit, Michigan 48201
Detroit, Michigan 48201
Principal Investigator: Hossein Salimnia, Ph.D
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2401 Gillham Rd
Kansas City, Missouri 64108
Kansas City, Missouri 64108
(816) 234-3000
Principal Investigator: Raj Selvarangan
Phone: 816-234-3031
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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Indianapolis, Indiana 46202
Principal Investigator: Bryan H Schmitt, Dr.
Phone: 317-630-6331
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Madera, California 93638
Principal Investigator: Nael Mhaissen
Phone: 559-353-6450
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Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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