Prospective, Non-Randomized, Parallel Assignment and Single Site Comparison of EPM-IX to Currently Used Specimen Transportation and Extraction Devices
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 205
- Locations
- 1
- Primary Endpoint
- Comparison of Diagnostic Performance
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
Comparison of Diagnostic Performance
Time Frame: At the time of inclusion
Comparison of diagnostic performances (sensitivity, specificity, and predictive values) of EPM-IX vs Med Schenker's STM viral media with detection of SARS-CoV-2 infection.
Secondary Outcomes
- Quantitative PCR CT-values(At the time of inclusion)
- Comparison of Lab Processing(At the time of inclusion)
- Difference in case rate or detection of viral load samples observed(At the time of inclusion)