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

Completed

• Conditions: SARS-CoV-2

• Registration Number: NCT05281692
• Lead Sponsor: Convergent Genomics, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2022-02-02
• Study First Submitted: 2022-03-07
• Study First Submitted QC: 2022-03-07
• Study First Posted: 2022-03-16
• Primary Completion: 2022-03-21
• Study Completion: 2022-03-21
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-14
• Last Update Posted: 2022-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

UroPartners Urology Group; 🇺🇸 Chicago, Illinois, United States