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

ArmDescriptionAssigned Intervention
Positive Enhanced Preservation Media (EPM-IX)
  • Diagnostic Test: Enhanced Preservation Media (EPM-IX)
    EPM-IX is a clinical specimen collection medium that inactivates pathogens, preserves nucleic acids, and integrates DNA/RNA purification. EPM-IX eliminates the need for additional extraction reagents or kits and purifies DNA/ RNA from the entire sample to enable optimal test performance.
Control Med Schenker's STM viral media
  • Diagnostic Test: Enhanced Preservation Media (EPM-IX)
    EPM-IX is a clinical specimen collection medium that inactivates pathogens, preserves nucleic acids, and integrates DNA/RNA purification. EPM-IX eliminates the need for additional extraction reagents or kits and purifies DNA/ RNA from the entire sample to enable optimal test performance.

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.