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

Study Overview
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Brief Summary
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This is a research study to evaluate the clinical utility of the Enhanced Preservation Media with Integrated Extraction (EPM-IX)

Detailed Description
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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.

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

Conditions
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SARS-CoV-2

Intervention / Treatment
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* Diagnostic Test: Enhanced Preservation Media (EPM-IX)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Positive<br>Enhanced Preservation Media (EPM-IX) | Diagnostic Test: Enhanced Preservation Media (EPM-IX)<br>* 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.<br>|
| Control<br>Med Schenker's STM viral media | Diagnostic Test: Enhanced Preservation Media (EPM-IX)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Diagnostic Performance | 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. | At the time of inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Lab Processing | Comparison of Lab processing time with accessioning and processing of an EPM-IX tube compared to with Med Schenker's STM viral media | At the time of inclusion | 
| Quantitative PCR CT-values | Quantitative PCR CT-values (of internal control and target gene levels) using EPM-IX vs Med Schenker's STM viral media | At the time of inclusion | 
| Difference in case rate or detection of viral load samples observed | Difference in case rate or detection of viral load samples observed between EPM-IX and Med Schenker's STM viral media | At the time of inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EPM-IX, Covid-19, SARS-CoV-2, Nasopharyngeal swab, Med Schenker's STM viral media