Comparison of EPM-IX to Currently Used Specimen Transportation and Extraction Devices ( CGI-EPM-IX )
Study Details
Study Description
Brief Summary
This is a research study to evaluate the clinical utility of the Enhanced Preservation Media with Integrated Extraction (EPM-IX)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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.
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| 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.
|
Outcome Measures
Primary Outcome Measures
- Comparison of Diagnostic Performance [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 Outcome Measures
- Comparison of Lab Processing [At the time of inclusion]
Comparison of Lab processing time with accessioning and processing of an EPM-IX tube compared to with Med Schenker's STM viral media
- Quantitative PCR CT-values [At the time of inclusion]
Quantitative PCR CT-values (of internal control and target gene levels) using EPM-IX vs Med Schenker's STM viral media
- Difference in case rate or detection of viral load samples observed [At the time of inclusion]
Difference in case rate or detection of viral load samples observed between EPM-IX and Med Schenker's STM viral media
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject must be ≥18 years of age
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Subject is a current patient at UroPartners and is willing to be tested for Covid- 19 during a routine visit
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Subject must be able to understand and willingly provide informed consent
Exclusion Criteria:
- Cannot provide informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UroPartners Urology Group | Chicago | Illinois | United States | 60657 |
Sponsors and Collaborators
- Convergent Genomics, Inc.
Investigators
- Principal Investigator: Paul Yonover, MD, UroPartners, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CGI-EPM-IX