NCT05281692

Comparison of EPM-IX to Currently Used Specimen Transportation and Extraction Devices ( CGI-EPM-IX )

Prospective, Non-Randomized, Parallel Assignment and Single Site Comparison of EPM-IX to Currently Used Specimen Transportation and Extraction Devices

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 205 (actual)
• Sponsor: Convergent Genomics, Inc. · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• SARS-CoV-2

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-02-02
• Primary completion: 2022-03-21
• Completion: 2022-03-21
• First posted: 2022-03-16
• Last updated: 2022-10-18

Locations

1 site across 1 country: United States