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

October 14, 2022 updated by: Convergent Genomics, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

205

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60657
        • UroPartners Urology Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Male and female subjects ≥ 18 years of age who are being tested for COVID-19

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Positive
Enhanced Preservation Media (EPM-IX)
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.
Control
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Lab Processing
Time Frame: 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
At the time of inclusion
Quantitative PCR CT-values
Time Frame: 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
At the time of inclusion
Difference in case rate or detection of viral load samples observed
Time Frame: 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
At the time of inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Convergent Genomics, Inc.

Investigators

  • Principal Investigator: Paul Yonover, MD, UroPartners, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 2, 2022

Primary Completion (ACTUAL)

March 21, 2022

Study Completion (ACTUAL)

March 21, 2022

Study Registration Dates

First Submitted

March 7, 2022

First Submitted That Met QC Criteria

March 7, 2022

First Posted (ACTUAL)

March 16, 2022

Study Record Updates

Last Update Posted (ACTUAL)

October 18, 2022

Last Update Submitted That Met QC Criteria

October 14, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CGI-EPM-IX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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