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

Convergent Genomics, Inc.205 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

205

Conditions

SARS-CoV-2

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

UroPartners Urology Group

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.