Official Title
Prospective, Non-Randomized, Parallel Assignment and Single Site Comparison of EPM-IX to Currently Used Specimen Transportation and Extraction Devices
Brief Title
Comparison of EPM-IX to Currently Used Specimen Transportation and Extraction Devices ( CGI-EPM-IX )
Protocol ID
NCT05281692
Lead Sponsor
Convergent Genomics, Inc.
Brief Summary
This is a research study to evaluate the clinical utility of the Enhanced Preservation
Media with Integrated Extraction (EPM-IX)
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.
Study Period
-
Enrollment Count
205 participants
Eligibility Criteria
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
Filters
SARS-CoV-2
COMPLETED
ADULT
OLDER_ADULT