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This is a research study to evaluate the clinical utility of the Enhanced Preservation Media with Integrated Extraction (EPM-IX)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive | Enhanced Preservation Media (EPM-IX) |
| |
| Control | Med Schenker's STM viral media |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Preservation Media (EPM-IX) | Diagnostic Test | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Male and female subjects ≥ 18 years of age who are being tested for COVID-19
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| Name | Affiliation | Role |
|---|---|---|
| Paul Yonover, MD | UroPartners, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UroPartners Urology Group | Chicago | Illinois | 60657 | United States |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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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.
|
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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |