Comparison of EPM-IX to Currently Used Specimen Transportation and Extraction Devices ( CGI-EPM-IX )
Purpose
This is a research study to evaluate the clinical utility of the Enhanced Preservation Media with Integrated Extraction (EPM-IX)
Condition
- SARS-CoV-2
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Subject must be ≥18 years of age - Subject is a current patient at UroPartners and is willing to be tested for Covid- 19 during a routine visit - Subject must be able to understand and willingly provide informed consent
Exclusion Criteria
- Cannot provide informed consent
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Positive | Enhanced Preservation Media (EPM-IX) |
|
Control | Med Schenker's STM viral media |
|
Recruiting Locations
More Details
- NCT ID
- NCT05281692
- Status
- Completed
- Sponsor
- Convergent Genomics, Inc.
Detailed Description
This is a minimal risk study where patients at UroPartners Urology Group will consent to SARS-CoV-2 nasopharyngeal swab testing using both, a standard of care test with standard Viral Transport Medium and a second test using Convergent Genomics' proprietary Enhanced Preservation Media (EPM-IX). Subjects will self-swab each nostril during their medical appointment at UroPartners. UroPartners designated staff with then send the collection kits out for testing. Clinical information will be collected that includes age, gender, race, ethnicity and history of cancer. All of these data points will be anonymized.