An observational study in SARS-CoV-2, sponsored by Convergent Genomics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-18.
Sponsored by Convergent Genomics, Inc. · Observational
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.
Convergent Genomics, Inc. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Male and female subjects ≥ 18 years of age who are being tested for COVID-19
Exclusion Criteria:
Enhanced Preservation Media (EPM-IX)
Diagnostic Test: Enhanced Preservation Media (EPM-IX)
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.
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.
Time frame: At the time of inclusion
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
Time frame: 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
Time frame: 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
Time frame: At the time of inclusion
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Convergent Genomics, Inc.