Status:
COMPLETED
Validation of the GenePOC Strep A, C/G Assay for Detecting Group A, C and G β-hemolytic Streptococcus From Throat Swabs.
Lead Sponsor:
Meridian Bioscience, Inc.
Conditions:
Pharyngitis, Infective
Eligibility:
All Genders
25+ years
Phase:
NA
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 meth...
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...
Eligibility Criteria
Inclusion
- 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
- • Patient/sample not meeting inclusion criteria above
Key Trial Info
Start Date :
February 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2018
Estimated Enrollment :
497 Patients enrolled
Trial Details
Trial ID
NCT03422341
Start Date
February 14 2018
End Date
July 11 2018
Last Update
May 4 2021
Active Locations (8)
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1
Valley Children's Hospital
Madera, California, United States, 93636
2
Wishard Health Services
Indianapolis, Indiana, United States, 46202
3
Detroit Medical Center University Laboratories
Detroit, Michigan, United States, 48201
4
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108